Development of a core outcome set for treatment studies for provoked vestibulodynia.

BACKGROUND: There is an inconsistency in treatment outcomes used in clinical trials for provoked vestibulodynia (PVD), which makes it impossible to compare the effects of different interventions. AIM: In this study, we completed the first step in creating a core outcome set (COS), defining what outcomes should be measured in clinical trials for PVD. METHODS: Identification of outcomes used in studies was done by extracting data from clinical trials in a recently published systematic review and via review of clinical trials for PVD registered on ClinicalTrials.gov. The COS process consisted of 2 rounds of Delphi surveys and a consensus meeting, during which the final COS was decided through a modified nominal group technique. OUTCOMES: Consensus on what outcomes to include in a COS for PVD. RESULTS: Forty scientific articles and 92 study protocols were reviewed for outcomes. Of those, 36 articles and 25 protocols were eligible, resulting in 402 outcomes, which were then categorized into 63 unique outcomes. Participants consisted of patients, relatives/partners of patients, health care professionals, and researchers. Out of 463 who registered for participation, 319 and 213 responded to the first and second surveys, respectively. The consensus meeting consisted of 18 members and resulted in 6 outcomes for the COS to be measured in all treatment trials regardless of intervention: insertional pain (nonsexual), insertional pain (sexual), provoked vulvar pain by pressure/contact, pain-related interference on one's life, pain interference on sexual life, and sexual function. CLINICAL IMPLICATIONS: Critical outcomes to be measured in clinical trials will allow for accurate comparison of outcomes across treatment interventions and provide solid treatment recommendations. STRENGTHS AND LIMITATIONS: The major strengths of the study are the adherence to methodological recommendations and the intentional focus on aspects of diversity of participating stakeholders (eg, status such as patients with lived experience and researchers, inclusiveness with respect to sexual identity), the latter of which will allow for broader application and relevance of the COS. Among the limitations of the study are the low rate of participants outside North America and Europe and the lower response rate (about 50%) for the second Delphi survey. CONCLUSION: In this international project, patients, health care professionals, and researchers have decided what critical outcomes are to be used in future clinical trials for PVD. Before the COS can be fully implemented, there is also a need to decide on how and preferably when the outcomes should be measured.

Accuracy of the Swedish quality registry for caries and periodontal diseases (SKaPa) - evaluation in 6- and 12-year-olds in the region of Värmland, Sweden.

OBJECTIVES: This study evaluates the agreement of data on dental caries between electronic dental records and data retrieved from the national SKaPa-registry (Swedish Quality Registry for caries and periodontal disease), with special reference to e/M in deft/DMFT. METHODS: In a random sample of 500 6- and 12-year-old children having received dental care in 2014 in the county region of Värmland, Sweden, the diagnostic accuracy of data in electronic dental records with corresponding data obtained from the SKaPa-registry was compared by using Cohen's Kappa and Intraclass correlation coefficient (ICC). RESULTS: For dft/DFT the Kappa was 0.95, and ICC 0.98 (total population). For deft/DMFT in the total population the Kappa was 0.80 and ICC 0.96. For 6-year-olds (deft) the Kappa was 0.89 and ICC 0.99 and for 12-year-olds (DMFT) the Kappa was 0.70, and ICC 0.83. The corresponding figures for Kappa and ICC when excluding individuals without caries (deft/DMFT = 0) were: Total population 0.63 and 0.94; 6-year-olds 0.79 and 0.99; 12-year-olds 0.42 and 0.68. CONCLUSION: Agreement between data in the dental records and SKaPa was very high for dft/DFT confirming that transfer from the dental records to the SKaPa-registry is safe and correct. As the accuracy of deft/DMFT was considerably lower than for dft/DFT we advise against using deft/DMFT data from SKaPa for research purposes at this point.

How old are you? A systematic review investigating the relationship between age and mandibular third molar maturity.

INTRODUCTION AND OBJECTIVE: Radiographic evaluation of the maturity of mandibular third molars is a common method used for age estimation of adolescents and young adults. The aim of this systematic review was to examine the scientific base for the relationship between a fully matured mandibular third molar based on Demirjian's method and chronological age, in order to assess whether an individual is above or below the age of 18 years. METHODS: The literature search was conducted in six databases until February 2022 for studies reporting data evaluating the tooth maturity using Demirjian´s method (specifically stage H) within populations ranging from 8 to 30 years (chronological age). Two reviewers screened the titles and abstracts identified through the search strategy independently. All studies of potential relevance according to the inclusion criteria were obtained in full text, after which they were assessed for inclusion by two independent reviewers. Any disagreement was resolved by a discussion. Two reviewers independently evaluated the risk of bias using the assessment tool QUADAS-2 and extracted the data from the studies with low or moderate risk of bias. Logistic regression was used to estimate the relationship between chronological age and proportion of subjects with a fully matured mandibular third molar (Demirjian´s tooth stage H). RESULTS: A total of 15 studies with low or moderate risk of bias were included in the review. The studies were conducted in 13 countries and the chronological age of the investigated participants ranged from 3 to 27 years and the number of participants ranged between 208 and 5,769. Ten of the studies presented the results as mean age per Demirjian´s tooth stage H, but only five studies showed the distribution of developmental stages according to validated age. The proportion of subjects with a mandibular tooth in Demirjian´s tooth stage H at 18 years ranged from 0% to 22% among males and 0 to 16% in females. Since the studies were too heterogenous to perform a meta-analysis or a meaningful narrative review, we decided to refrain from a GRADE assessment. CONCLUSION: The identified literature does not provide scientific evidence for the relationship between Demirjian´s stage H of a mandibular third molar and chronologic age in order to assess if an individual is under or above the age of 18 years.

Impact of direct oral anticoagulants on bleeding tendency and postoperative complications in oral surgery: a systematic review of controlled studies.

OBJECTIVE: The recommendations for the management of direct oral anticoagulants (DOACs) in oral surgery are inconsistent. The present review evaluated whether DOACs increase the risk of bleeding during oral surgery and postoperative complications. STUDY DESIGN: The patients undergoing oral surgery and receiving a DOAC were compared with the patients receiving a DOAC different from the exposure, a vitamin K antagonist (VKA), or no anticoagulant. Three electronic databases were searched for eligible clinical trials and systematic reviews. The risk of bias was assessed, data were extracted, a meta-analysis was done, and the Grading of Recommendations, Assessment, Development and Evaluations certainty-of-evidence ratings were determined. RESULTS: Three clinical trials comparing patients receiving DOAC medication with patients on a VKA were eligible. A meta-analysis of bleeding 7 days postoperatively detected no significant differences between patients continuing DOAC or VKA medication during and after surgery. All of the point estimates favored uninterrupted DOAC over VKA therapy. Tranexamic acid was topically administered to some patients. CONCLUSIONS: Based on an interpreted trend among 3 studies with mixed patient populations, the risk of bleeding during the first 7 postoperative days may be lower for patients on uninterrupted DOAC than VKA therapy (⨁⨁⭘⭘), but the effect size of the risk is unclear. 80 of 274 included patients experienced postoperative bleeding.

Swedish quality registry for caries and periodontal diseases (SKaPa): validation of data on dental caries in 6- and 12-year-old children.

BACKGROUND: The Swedish Quality Registry for caries and periodontal disease (SKaPa) automatically collects data on caries and periodontitis from patients' electronic dental records. Provided the data entries are reliable and accurate, the registry has potential value as a data source for registry-based research. The aim of this study was to evaluate the reliability and accuracy of the SKaPa registry information on dental caries in 6- and 12-year-old children. METHOD: This diagnostic accuracy study compared dental caries data registered at an examination with dental health status registered in the patient's electronic dental records, and with corresponding data retrieved from the SKaPa registry. Clinical examinations of 170 6- and 12-year-old children were undertaken by one of the researchers in conjunction with the children's regular annual dental examinations where the number of teeth were registered, and dental caries was diagnosed using ICDAS II. Teeth with fillings were defined as filled and were added to the ICDAS II score and subsequently dft/DFT was calculated for each individual. Cohen's Kappa, the intraclass correlation coefficient (ICC), and sensitivity and specificity were calculated to test the agreement of the 'decayed and filled teeth' in deciduous and permanent teeth (dft/DFT) from the three sources. RESULTS: Cohen's Kappa of the dft/DFT-values was calculated to 0.79 between the researcher and the patient record, to 0.95 between patient dental record and SKaPa, and to 0.76 between the researcher and SKaPa. Intraclass correlation coefficient (ICC) was calculated to 0.96 between the researcher and the patient journal, to 0.99 between the patient dental record vs. SKaPa, and to 0.95 between the researcher and SKaPa. CONCLUSION: The SKaPa registry information demonstrated satisfactory reliability and accuracy on dental caries in 6- and 12-year-old children and is a reliable source for registry-based research. Trial registration The study was registered in Clinical Trials ( www.ClinicalTrials.gov , NCT03039010).

The risk for infraposition of dental implants and ankylosed teeth in the anterior maxilla related to craniofacial growth, a systematic review.

BACKGROUND: The aim of the study was to evaluate a potential association between individuals with different craniofacial types or other exposures, and the risk of infraposition due to continued growth/eruption of adjacent teeth in the anterior maxilla. MATERIALS AND METHODS: This is a systematic review in which primary studies as well as other systematic reviews are scrutinised. A search of PubMed (Medline), Scopus, Web of science and Health technology assessment (HTA) organisations and a complementary handsearch was carried out. Selected studies were read in full-text by several reviewers. The quality of the included primary studies was assessed using a protocol for assessment of risk of bias in exposure studies. RESULTS: The literature search resulted in 3,296 publications. Title and abstract screening yielded 25, whereof one systematic review, potential publications allocated for full-text inspection. The quality assessment resulted in a total of seven studies with a low/moderate risk of bias and four studies with a high risk of bias. CONCLUSION: In conclusion, a long-term risk for infraposition of dental implants, or ankylosed teeth, among natural teeth can be observed in some cases. The predisposing factors are still not fully understood since the current scientific evidence is very limited.

Cost-effectiveness of caries preventive interventions - a systematic review.

OBJECTIVE: The primary purpose of this study was to assess the cost-effectiveness of caries preventive interventions. MATERIAL AND METHODS: A systematic review was conducted, following the PRISMA Statement. Four electronic databases were searched (final search 16 March 2020). Studies fulfilling the inclusion criteria were independently critically appraised, by two reviewers in parallel. Data from each included study were extracted and tabulated: the analysis used a narrative approach to present the results of the estimated cost-effectiveness. RESULTS AND CONCLUSIONS: Twenty-six publications fulfilled the inclusion criteria and were of low or moderate risk of bias. Ten publications were economic evaluations, directly based on empirical studies, and the other 16 were modelling studies. Most of the studies concerned interventions for children and the most common were analyses of fluoride varnish and risk-based programs. Some of the studies showed both reduced cost and improved outcomes, but most studies reported that the improved outcome came with an additional cost. The results disclosed several cost-effectiveness evaluations of caries preventive interventions in the literature, but these target primarily children at high risk. There is a scarcity of studies specifically targeting adults and especially the elderly.

Prophylactic antibiotics for staged bone augmentation in implant dentistry.

Background: The objective of the study was to assess the effect of prophylactic antibiotics on the outcome of bone augmentation and subsequent dental implant placement by combining the recommended quality assessment methods for systematic reviews and primary studies.Materials and methods: This is a complex systematic review in which systematic reviews as well as primary studies are scrutinised. A search of Medline (OVID), The Cochrane Library (Wiley) and EMBASE, PubMed and Health technology assessment (HTA) organisations as-well as a complementary hand-search was carried out. Selected primary studies were assessed using GRADE. Each study was reviewed by three authors independently.Results: Abstract screening yielded six potential systematic reviews allocated for full-text inspection. A total of ten primary studies were read in full-text. No relevant systematic reviews regarding the topic of this article were found. The quality assessment resulted in two primary studies with a moderate risk of bias. Of the two studies with a moderate risk of bias, one compared a single dose of clindamycin 600 mg preoperatively with the same preoperative dose followed by four doses of 300 mg every 6 h. The second study compared a single dose prophylaxis of two different types of antibiotic compounds.Conclusion: In conclusion, the scientific evidence regarding the use of antibiotic prophylaxis for reducing the risk of infection in conjunction with bone augmentation procedures during dental implant placement is very limited. The infection rate as compared to nonusage of prophylactic antibiotics, selection of the most suitable compound, and the optimal duration of prophylactic treatment is still unknown.

Organisational models of health services for children and adolescents in out-of-home care: Health technology assessment.

AIM: Decades of research confirm that children and adolescents in out-of-home care (foster family, residential care) have much greater health care needs than their peers. A systematic literature review was conducted to evaluate organisational health care models for this vulnerable group. METHODS: A systematic literature search was undertaken of the following databases: Academic Search Elite, CENTRAL, Cochrane Database of Systematic Reviews, Cinahl, DARE, ERIC, HTA, PsycInfo, Psychology and Behavioural Sciences Collection, PubMed, SocIndex. Randomised and non-randomised controlled trials were to be included. Two pairs of reviewers independently assessed abstracts of the identified published papers. Abstracts meeting the inclusion criteria were ordered in full text. Each article was reviewed independently, by pairs of reviewers. A joint assessment was made based on the inclusion criteria and relevance. Cases of disagreement were resolved by consensus discussion. RESULTS: No study with low or medium risk of bias was identified. CONCLUSION: In the absence of studies of acceptable quality, it is not possible to assess the impact of organisational models intended to ensure adequate health and dental care for children and adolescents in out-of-home care. Therefore, well-designed follow-up studies should be conducted following the implementation of such models.

Caries as experienced by adult caries active patients: a qualitative study.

Objective: In the western world, increased oral health has resulted in a skewed occurrence of caries disease where relatively few individuals now account for most caries disease. This study examines how adults with recurrent caries activity experience caries disease and treatment.Materials and methods: The study is based on qualitative data from individual interviews, which were subjected to qualitative content analysis. The interviews were semi-structured and thematic and an interview guide was used that consisted of two main areas with open ended questions. Meaning units were condensed and labelled with a code which preserved the core content of the reduced text. Codes were assigned to different subcategories according to their similarities or differences. Subcategories formed categories which describe the manifest content of the text.Results: The domain "experience with caries" consisted of four subcategories that formed the main category Caries - an unwelcomed acquaintance. The domain "experience with caries treatment" consisted of three subcategories that formed the category Caries treatment - pain for gain.Conclusion: Comprehensive non-operative treatment and close follow-ups should precede restorations; this would probably gain insight in how to avoid new cavities to a greater extent. If to be supportive, information and advice about self-care given to individuals with recurrent cavities should be delivered with respect to the patient's feelings about their experience of dental caries.

Oral health and dental care of older persons-A systematic map of systematic reviews.

OBJECTIVES: To examine the current knowledge on oral health status and dental care of older persons through a systematic mapping of systematic reviews of low or moderate risk of bias. BACKGROUND: Geriatric dentistry covers all aspects of oral health and oral care of older persons. Oral health is part of general health and contributes to a person's physical, psychological and social wellbeing. METHODS: A literature search was performed in three different databases (PubMed, The Cochrane Library and Cinahl) within 12 domains: Dental caries, periodontitis, Orofacial pain and temporomandibular joint (TMJ) pain, mucosal lesions, oral motor function, dry mouth, halitosis, interaction between oral status and other medical conditions, ability to interrelate and communicate, quality of life, ethics and organisation of dental care for older persons. Systematic reviews were identified and scrutinised, highlighting scientific knowledge and knowledge gaps. RESULTS: We included 32 systematic reviews of which 14 were judged to be of low/moderate risk of bias. Most of the domains lack systematic reviews with low or moderate risk of bias. In two of the domains evidence was identified; in institutionalised people aged 65 or older, effective oral hygiene can prevent pneumonia. Furthermore, there is an evidence of a relationship between malnutrition (protein energy-related malnutrition, PEM) and poor appetite and edentulousness. CONCLUSIONS: There is an urgent need for further research and evidence-based knowledge within most domains in geriatric dentistry and in other fields related to oral health and dental care for older persons striving for multi-disciplinary research programmes.

Antibiotic prophylaxis in orthognathic surgery: A complex systematic review.

OBJECTIVE: In orthognathic surgery, antibiotics are prescribed to reduce the risk of postoperative infection. However, there is lack of consensus over the appropriate drug, the dose and duration of administration. The aim of this complex systematic review was to assess the effect of antibiotics on postoperative infections in orthognathic surgery. METHODS: Both systematic reviews and primary studies were assessed. Medline (OVID), The Cochrane Library (Wiley) and EMBASE (embase.com), PubMed (non-indexed articles) and Health Technology Assessment (HTA) publications were searched. The primary studies were assessed using GRADE and the systematic reviews by AMSTAR. RESULTS: Screening of abstracts yielded 6 systematic reviews and 36 primary studies warranting full text scrutiny. In total,14 primary studies were assessed for risk of bias. Assessment of the included systematic reviews identified two studies with a moderate risk of bias, due to inclusion in the meta-analyses of primary studies with a high risk of bias. Quality assessment of the primary studies disclosed one with a moderate risk of bias and one with a low risk. The former compared a single dose of antibiotic with 24 hour prophylaxis using the same antibiotic; the latter compared oral and intravenous administration of antibiotics. Given the limited number of acceptable studies, no statistical analysis was undertaken, as it was unlikely to contribute any relevant information. CONCLUSION: With respect to antibiotic prophylaxis in orthognathic surgery, most of the studies to date have been poorly conducted and reported. Thus scientific uncertainty remains as to the preferred antibiotic and the optimal duration of administration.

Effects of Bacterial Contamination on Dental Implants During Surgery: A Systematic Review.

INTRODUCTION: Contamination during surgery negatively influences the prognosis of orthopaedic implants; however, it has not been proven whether contamination influences the success of dental implant treatment. The aim of the systematic review was to investigate if there exists evidence in the literature whether contamination of dental implants during surgery affects osseointegration and clinical success. MATERIALS AND METHODS: Four data bases were used for the literature search. Primary studies and reviews regarding both clinical and preclinical research were eligible. Rating of the summarized quality of the evidence was performed. RESULTS: Five preclinical studies were included. Because of the estimated high risk of bias in all included studies and extensive differences in study design between the included studies, meta-analysis was not performed and no reliable aggregated data could be extracted. CONCLUSIONS: It is suggested that the scientific evidence with regard to the current topic is insufficient. Further controlled studies are warranted.

KNOWLEDGE GAPS IN ORAL AND MAXILLOFACIAL SURGERY: A SYSTEMATIC MAPPING.

OBJECTIVES: The aim of this study was to evaluate available knowledge and identify knowledge gaps within the field of oral and maxillofacial surgery, by systematically collecting and evaluating systematic reviews. Twelve specific domains were selected: surgical removal of teeth, antibiotic and corticosteroid prophylaxis, orofacial infections, dental and facial trauma, orthognathic surgery, reconstructive surgery, benign tumors, cysts, premalignant lesions, oral complications of treatment of malignant tumors, hyperbaric oxygen therapy, temporomandibular joint surgery, cost effectiveness of different surgical treatments, and ethics. METHODS: The literature search, covering four databases, was conducted during September 2014: PubMed, The Cochrane library, Centre for Reviews and Dissemination and EBSCO dentistry and oral science source. Retrieved systematic reviews were quality assessed by AMSTAR. RESULTS: In all, 1,778 abstracts were identified, of which 200 met the inclusion criteria. Forty-five systematic reviews were assessed as of high to moderate quality. The results disclosed some existing evidence in a few domains, such as surgical removal of teeth and implant survival after sinus lifts. However, in all domains, the search revealed a large number of knowledge gaps. Also of concern was the lack of data regarding health economics and ethics. CONCLUSIONS: In conclusion, there is a need for well-conducted clinical research in the fields of oral and maxillofacial surgery.

The GRADE Working Group clarifies the construct of certainty of evidence.

OBJECTIVE: To clarify the grading of recommendations assessment, development and evaluation (GRADE) definition of certainty of evidence and suggest possible approaches to rating certainty of the evidence for systematic reviews, health technology assessments, and guidelines. STUDY DESIGN AND SETTING: This work was carried out by a project group within the GRADE Working Group, through brainstorming and iterative refinement of ideas, using input from workshops, presentations, and discussions at GRADE Working Group meetings to produce this document, which constitutes official GRADE guidance. RESULTS: Certainty of evidence is best considered as the certainty that a true effect lies on one side of a specified threshold or within a chosen range. We define possible approaches for choosing threshold or range. For guidelines, what we call a fully contextualized approach requires simultaneously considering all critical outcomes and their relative value. Less-contextualized approaches, more appropriate for systematic reviews and health technology assessments, include using specified ranges of magnitude of effect, for example, ranges of what we might consider no effect, trivial, small, moderate, or large effects. CONCLUSION: It is desirable for systematic review authors, guideline panelists, and health technology assessors to specify the threshold or ranges they are using when rating the certainty in evidence.

TOP TEN RESEARCH PRIORITIES FOR ATTENTION DEFICIT/HYPERACTIVITY DISORDER TREATMENT.

OBJECTIVES: The aim of this project was to identify the ten most important research questions for attention deficit/hyperactivity disorder (ADHD) treatment as identified by people with ADHD together with personnel involved in the treatment of ADHD in school, health, and correction services. METHODS: A working group consisting of consumers and personnel was established. The method for prioritization was primarily based on James Lind Alliance's guidebook, consisting of an interim priority setting exercise and a workshop. RESULTS: The top ten list includes the risk of drug dependency later in life when treated with methylphenidate as a child, teacher support, multimodal therapy, comparisons between atomoxetine and methylphenidate, methylphenidate treatment in substance abusers, parental support programmes, supported conversation, computer-aided working memory training, psychoeducative treatment, and melatonin. CONCLUSIONS: We have shown that consumers and personnel can reach consensus on research priorities for treatments for ADHD. We encourage researchers and funders to consider the list for future studies.

Arginine and Caries Prevention: A Systematic Review.

OBJECTIVES: To evaluate the available evidence that the use of arginine-containing dental care products prevents the development of new caries lesions and the progression of existing lesions. SEARCH METHODS: We performed a systematic literature search of databases including PubMed, the Cochrane Library and EMBASE. SELECTION CRITERIA: We selected randomized controlled trials of treatment with arginine in fluoride-containing dental products measuring dental caries incidence or progression in children, adults and elderly subjects. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for risk of bias and evaluated overall study quality using the GRADE classification. MAIN RESULTS: Due to conflicts of interest and weak transferability to Swedish conditions, no conclusions can be drawn from studies on the effects of arginine-fluoride toothpaste in children. Arginine-containing toothpaste costs about 40% more than basic fluoride toothpaste; to determine whether it is more cost-effective, the higher cost must be considered in relation to any additional caries-preventive effect. The literature review also disclosed some questionable research ethics: in several of the studies, the children in the control group used non-fluoride toothpaste. Toothpaste without fluoride is not as effective against dental caries as the standard treatment - fluoride toothpaste - which has a well-documented effect. This contravenes the fundamental principles of research ethics. CONCLUSION: At present there is insufficient evidence in support of a caries-preventive effect for the inclusion of arginine in toothpastes. More rigorous studies, and studies which are less dependent on commercial interests, are required.

Framework for systematic identification of ethical aspects of healthcare technologies: the SBU approach.

OBJECTIVES: Assessment of ethical aspects of a technology is an important component of health technology assessment (HTA). Nevertheless, how the implementation of ethical assessment in HTA is to be organized and adapted to specific regulatory and organizational settings remains unclear. The objective of this study is to present a framework for systematic identification of ethical aspects of health technologies. Furthermore, the process of developing and adapting the framework to a specific setting is described. METHODS: The framework was developed based on an inventory of existing approaches to identification and assessment of ethical aspects in HTA. In addition, the framework was adapted to the Swedish legal and organizational healthcare context, to the role of the HTA agency and to the use of non-ethicists. The framework was reviewed by a group of ethicists working in the field as well as by a wider set of interested parties including industry, interest groups, and other potential users. RESULTS: The framework consists of twelve items with sub-questions, short explanations, and a concluding overall summary. The items are organized into four different themes: the effects of the intervention on health, its compatibility with ethical norms, structural factors with ethical implications, and long term ethical consequences of using the intervention. CONCLUSIONS: In this study, a framework for identifying ethical aspects of health technologies is proposed. The general considerations and methodological approach to this venture will hopefully inspire and present important insights to organizations in other national contexts interested in making similar adaptations.

Complex systematic review - Perioperative antibiotics in conjunction with dental implant placement.

OBJECTIVES: The aim of this study was to revisit the available scientific literature regarding perioperative antibiotics in conjunction with implant placement by combining the recommended methods for systematic reviews and complex systematic reviews. MATERIAL AND METHODS: A search of Medline (OVID), The Cochrane Library (Wiley), EMBASE, PubMed and Health technology assessment (HTA) organizations was performed, in addition to a complementary hand-search. Selected systematic reviews and primary studies were assessed using GRADE and AMSTAR, respectively. A meta-analysis was performed. RESULTS: The literature search identified 846 papers of which 10 primary studies and seven systematic reviews were included. Quality assessment of the systematic reviews revealed two studies of moderate risk of bias and five with high risk of bias. The two systematic reviews of moderate risk of bias stated divergent numbers needed to treat (NNT) to prevent one patient from implant failure. Four of the primary studies comparing antibiotic prophylaxis with placebo were estimated to be of low, or moderate, risk of bias and subjected to meta-analysis. The NNT was 50 (pooled RR 0.39, 95% CI 0.18, 0.84; P = 0.02). None of these four studies individually show a statistical significant benefit of antibiotic prophylaxis. Furthermore, narrative analysis of the studies eligible for meta-analysis reveals clinical heterogeneity regarding intervention and smoking. CONCLUSION: Antibiotic prophylaxis in conjunction with implant placement reduced the risk for implant loss by 2%. However, the sub-analysis of the primary studies suggests that there is no benefit of antibiotic prophylaxis in uncomplicated implant surgery in healthy patient.