Immediate versus delayed implant placement of novel fully tapered tissue-level implants - A retrospective multicenter clinical study.

OBJECTIVES: To compare the clinical and radiological outcomes of novel fully tapered tissue-level implants in immediate implant placement (type 1) versus late implant placement (type 4) for the first time. MATERIALS AND METHODS: For this clinical study, 318 fully tapered tissue-level implants in 65 patients were inserted immediately (n = 68 implants) or late (n = 250 implants) in two different centers. Implant survival and success rates and marginal bone levels were analyzed. RESULTS: After a mean follow-up of 12.0 ± 5 months, implant survival rates were 97.8% for all implants. No statistically significant difference in implant survival rates between type 1 and type 4 could be detected (98.5% vs 97.6%, HR 0.70, 95%-CI 0.084-5.81). Neither for implant length (HR 0.53, 95%-CI 0.055-5.08) nor for implant width (HR 0.27, CI 0.028-2.55), a significant influence on implant survival could be detected. Type of used biomaterial for filling the gap and immediate loading showed no effect on implant survival. Mean marginal bone loss was 0.02 ± 0.05 mm for type 1 and 0.04 ± 0.1 for type 4. CONCLUSIONS: Within the limitations of this retrospective study and the short follow-up, the results demonstrated comparable high survival and success rates and stable marginal bone levels for type 1 and type 4 placement of this novel tissue-level implant (no clinical trial registration as retrospective study design).

Association between breast cancer chemotherapy, oral health and chronic dental infections: a pilot study.

Breast cancer has developed to become the leading type of cancer in females. For this study, 80 women were examined after chemotherapy for breast cancer and compared to 80 healthy age-matched women. This cross-sectional study comprised a dental examination with number of teeth, caries frequency (DMFT) and the presence of periodontal diseases (PSI). With the help of X-rays (OPG), the number of root canal fillings and apical lesions (LEO/LPO) were recorded. Furthermore, the education level, body mass index (BMI), smoking habits and general health conditions were recorded. All women completed questionnaires on oral health-related quality of life (OHIP-G14) and general well-being (HADS-D). To assess the influence of cancer therapy on oral health parameters, appropriate generalized linear models were fitted with disease status as main explanatory variable, adjusting for age and education. For OHIP and HADS, we additionally adjusted for number of missing teeth. The examined 160 women showed a comparable mean age (60.4 years) and an average BMI of 24.6. Cancer patients showed a higher risk for missing teeth (p < 0.001) and more apical lesions (p < 0.0041), particularly those of endodontic origin without root canal fillings (p = 0.0046), than the control women. The general well-being of cancer patients was significantly reduced with a HADS score of 9.4 for women with breast cancer compared to 5.3 for the healthy control. This study suggests that women after breast cancer chemotherapy are inclined to have a poorer oral health status with more missing teeth and apical lesions. Therefore, tightly scheduled dental recall visits should be recommended.

Photodynamic Therapy has no Adverse Effects In Vitro on Human Gingival Fibroblasts and Osteoblasts.

BACKGROUND: Invasion of periodontal pockets with persistent microorganisms and subsequent development of a biofilm are the main cause of periodontal infections. In severe cases, additional use of antibiotics to the standard therapy of scaling and root planing (SRP), is necessary, but the use of antibiotics may lead to resistance. As an alternative, the combination of SRP and adjunct photodynamic therapy (PDT) is applied in the treatment of periodontal infections to improve periodontal therapy. The aim of this study was to determine possible side effects of PDT on human gingival fibroblasts (GF) and human osteoblasts (OB). METHODS: GF and OB were either untreated or treated with methylene blue (MB) only, with MB and subsequently irradiation with a soft laser (PDT) or irradiated with a soft laser only. All cells were analyzed for viability using the MTT test, migration capacity using Boyden chambers, and the scratch wound assay. RESULTS: Viability and migration capacity of GF and OB were not affected by PDT (for GF: p = 0.48, for OB: p = 0.08 compared to control group) whereas soft laser irradiation only improved cell viability and migration and MB treatment only reduced cell viability and migration. After 72 hours of incubation of both GF and OB, the gaps were almost closed. CONCLUSIONS: In vitro, PDT did not affect viability and migration capacity of GF and OB whereas soft laser treatment only had a positive effect on GF and OB. Therefore, PDT seems to be a safe method in the treatment of periodontal infections without significant side effects.

Efficacy of photodynamic therapy as adjunct treatment of chronic periodontitis: a systematic review and meta-analysis.

Meta-analysis of treatment effects of antimicrobial photodynamic therapy (aPDT) adjunct to non-surgical scaling and root planing (SRP) in comparison to SRP alone on patients with chronic periodontitis. The meta-analysis was performed according to PRISMA statement and Cochrane Collaboration guidelines. Electronic search complemented by hand search assured a high yield of randomized controlled trials (RCTs) of aPDT as adjunct modality to SRP. Differences in probing depth (PD) and clinical attachment level (CAL) were calculated with 95% confidence intervals and pooled in a random effects model. Analysis for intra- and inter-study heterogeneity was provided by χ 2 and I 2 tests, and publication bias was checked by funnel plots. Pooled overall effects of 26 RCTs attested significant benefits of aPDT adjunct to SRP with respect to PD reduction (MD 0.37; 95% CI 0.12-0.53; P < 0.0001) and CAL gain (MD 0.33; 95% CI 0.19-0.48; P < 0.00001) after 3 and 6 months. Sensitivity analysis minimized heterogeneity of PD reduction (MD 0.21; 95% CI 0.13-0.30; P < 0.00001) and CAL gain (MD 0.36; 95% CI 0.27-0.46). aPDT adjunct to SRP provides significant PD reduction and CAL gain in treatment of chronic periodontitis. This moderate effect was found after 3 and 6 months which is short from a clinical perspective.

Comparison of conventional twist drill protocol and piezosurgery for implant insertion: an ex vivo study on different bone types.

OBJECTIVE: The aim of this ex vivo study was to compare implant insertion procedures using piezosurgery and conventional drilling in different qualities of bone. Implant bed preparation time, generated heat, and primary implant stability were analyzed. MATERIAL AND METHODS: Fresh ex vivo porcine bone block samples (cancellous, mixed, and cortical bone) were obtained. The bone quality was quantified by ultrasound transmission velocity (UTV). Each bone sample received three implants of the same diameter using each of the techniques of piezosurgery and conventional twist drills. Time for preparation was taken and the temperature while performing the osteotomy was measured using infrared spectroscopy. The primary implant stability after osteotomy was measured using resonance frequency analysis (RFA) and extrusion torque (ET). ANOVA with post hoc Tukey test was carried out to compare the values for the three different groups. RESULTS: The UTV values strongly correlated with the density of the bone samples. There was a significant increase in time (threefold, P < 0.05 [302 s vs. 122 s in cortical bone]) but no difference in the temperature for the piezo group (~37°C in cortical bone). Regardless of the osteotomy technique, there was a statistically significant increase in RFA and ET values in implants inserted in cancellous bone (RFA: piezo 77, drill 76; ET: piezo 22, drill 21), mixed bone (RFA: piezo 85, drill 86; ET: piezo 105, drill 61), and cortical bone (RFA: piezo 90, drill 87; ET piezo 184, drill 79) samples, respectively (P < 0.05). In between the different osteotomy groups, there was no difference in the RFA values but significant higher ET values in mixed/cortical bone samples in favor for the piezosurgery group. CONCLUSION: Piezosurgery and conventional implant bed drilling procedure do have similar mechanical outcomes regarding primary stability with high RFA values, but the preparation does need more time for piezosurgery group, so that piezosurgery might be a valuable tool in only very specific cases for implant bed preparation.

Root coverage with connective tissue graft associated with coronally advanced flap or tunnel technique: a randomized, double-blind, mono-centre clinical trial.

AIM: The aim of this randomized clinical trial was to compare the coronally advanced flap (CAF) with the modified microsurgical tunnel technique (MMTT) for treatment of Miller class I and II recessions. MATERIAL AND METHODS: Forty patients with 71 gingival recessions were recruited and randomly assigned to either CAF or to MMTT. In both groups, a connective tissue graft was applied. Clinical evaluations were performed after 3, 6, and 12 months. Impressions were taken and digitally scanned three-dimensionally to evaluate the quantitative soft tissue changes in the operative region. Patient satisfaction was measured with the root coverage aesthetic score (RES). RESULTS: After a period of 12 months, significant differences were not found between the two groups. Root coverage was 98.3% for CAF and 97.2% for MMTT. The evaluation of the aesthetic outcome using RES showed good results in both groups. The RES score was in accordance with subjective patient satisfaction. There was no significant difference in the amount of volumetric changes. CONCLUSIONS: CAF and MMTT with the additional use of a graft are equally successful in covering gingival recessions of Miller class I and II, with high aesthetic results. All patients indicated their willingness for further periodontal surgery.

Efficacy of an aluminium triformate mouthrinse during the maintenance phase in periodontal patients: a pilot double blind randomized placebo-controlled clinical trial.

BACKGROUND: The aim of this prospective placebo-controlled pilot study was to evaluate short-term effects of a mouthrinse containing aluminium triformate (ATF) on gingival inflammation and plaque formation in periodontal patients who are in the maintenance phase. ATF has styptic (astringent) and anti-inflammatory effects. METHODS: Forty non-smoking periodontal patients with modified sulcus bleeding index (MSBI) ≥40 % were randomly divided into two groups. The participants received a masked mouthrinse (ATF or placebo) and were instructed with the rinsing protocol of 3 daily rinses during 30 s for 7 days. One blinded investigator (CE) performed all clinical examinations. The primary outcome was reduction in gingival inflammation as measured by MSBI. The secondary outcomes were reduction of the amount of plaque as measured by plaque index (PI) and approximal plaque index (API) and the occurrence of side effects. The patients were evaluated at the start and the end of the rinsing period, including the compliance of the patients. RESULTS: MSBI was reduced in both groups compared to baseline, but the ATF group showed significantly more reduction in MSBI compared to the placebo group (ATF: 17.6 %, placebo: 7.6 %, p = 0.035). ATF and placebo had no effects on dental plaque. Patients reported ATF mouthrinse not to have side effects other than oral sensation, whereas compliance of the patients was good. Almost all patients in the ATF group reported reduction of gum bleeding after 1 week of rinsing with ATF. CONCLUSIONS: This short-term pilot clinical trial is a firm basis to design a long-term controlled clinical trial to show whether ATF helps to inhibit further periodontal breakdown in maintenance patients with high MSBI. TRIAL REGISTRATION: This trial was registered in the WHO International Clinical Trials Registry Platform as DRKS00007672 , date of registration: 21/01/2015.

Oral Hygiene and Dietary Habits in Adolescents with Fixed Orthodontic Appliances: A Cross-sectional Study.

OBJECTIVES: Fixed orthodontic appliances (FOAs) may cause a temporary deterioration of oral hygiene with corresponding gingival inflammatory changes. Optimal oral hygiene and dietary changes are essential in order to avoid periodontal inflammation. The present study investigates to what extent the recommendations made by the orthodontist are followed by young patients. MATERIALS AND METHODS: A total of 67 adolescent patients with FOA were examined and interviewed. The control group consisted of 70 patients of the same age who had not undergone any orthodontic treatment. A specific questionnaire (assessing dietary habits, oral hygiene measures) was used and comprehensive oral findings along with oral hygiene status were evaluated. RESULTS: The analysis of the data showed that despite intensive oral hygiene and dietary advice in the patients with FOA, there was no change in diet or oral hygiene habits. There were significantly higher signs of gingival inflammation and amount of dental plaque in FOA patients. Nutritional recommendations and oral hygiene measures for young people with FOA were not adequately enforced. CONCLUSION: The findings indicate that frequent recalls should be scheduled with repeated reinforcement of oral hygiene and dietary modifications in FOA patients.

Penetration Potential of a Silver Diamine Fluoride Solution on Dentin Surfaces. An Ex Vivo Study.

BACKGROUND: Occurrence of open dentinal tubules as a cause of dental hypersensitivity is a very common pnenomenon in patients. The aim of this in vitro study was to assess the effect of a silver diamine fluoride solution (Ag(NH3)2 F) on human dentin samples. METHODS: A total of five fully retained wisdom teeth were selected for this study. The crowns of the teeth were separated from the roots and the occlusal enamel surface was removed. All dentin samples were treated for 60 seconds with phosphoric acid (36%) and rinsed thoroughly to remove the smear layer. Then the desensitizing agent (Riva Star, SDI; 38% Ag(NH3)2 F) was placed according to the manufacturer's instruction. Three dentin samples were prepared for element analysis using an electron beam microprobe analyzer (JEOL JXA 8900RL). The Ag concentrations in the dentin samples were measured in depths ranging from 5 to 40 µm. The other two dentin samples were vertically fractured and accordingly prepared for visualization with SEM (Zeiss DSM). RESULTS: The application of the desensitizing agent on the dentin areas demonstrated an increased Ag concentration (JEOL JXA 8900RL). On the dentin surface an Ag concentration of 1.7 weight % (? 0.7) was measured, but at a depth of 20 µm only 0.3 weight % (± 0.1) were detected. In depths greater than 40 µm the Ag concentration was below the detection limit. The SEM results showed that deposits could be found in a covering on the dentin layer and in the dentinal tubules to a depth of 20 µm. CONCLUSIONS: In this ex vivo study, the effect of silver diamine fluoride on dentin surfaces could be demonstrated. The desensitizing agent formed a film on the dentin surface and in some dentinal tubules deposits were detected. These findings can explain a certain desensitizing effect, but a direct translation to in vivo conditions can only be done with caution.

Traumatic dental injuries in a university hospital: a four-year retrospective study.

BACKGROUND: Traumatic dental injuries present complex injuries of the dentoalveolar system. Aim of this study was to investigate the frequency and patterns of traumatic dental injuries in a University dental emergency service over four years. METHODS: A retrospective investigation on all dental trauma patients presenting at the dental emergency service of the University Medical Center Mainz, Germany between 01/2010 and 12/2013 was conducted. Demographic data, the cause and type of trauma and the initial therapy were analyzed. RESULTS: Out of 16,301 patients, 1,305 patients (8 %; average age 14.7 years ±15.7; 60.1 % male, 39.9 % female) came due to trauma. 63.9 % of the traumas occurred on weekends. The most frequent reason for injuries was falls (54.6 %). No correlation could be found between the cause and the kind of trauma. In 48.6 % of the cases only one tooth was involved, in 33.5 % two. The permanent dentition was traumatized in 56.6 % of cases, the deciduous teeth in 41.1 %. The most frequently affected tooth was the central upper incisor (61.0 %). Hard-tissue injuries were significantly more frequent in the permanent dentition, while periodontal injuries were seen significantly more often in the deciduous dentition. CONCLUSION: Eight percent of all patients seeking help at the dental emergency service presented with trauma, meaning that dental traumatology is one of the major topics in emergencies. To improve the quality of care, further public education, expert knowledge among dental professionals and a well-structured emergency service are necessary.

Odontogenic Infections: A 1-year Retrospective Study.

OBJECTIVES: The purpose of this study was to analyze the prevalence, demographic patterns and management of odontogenic infections in patients undergoing treatment in an outpatient dental emergency service of a university hospital. MATERIALS AND METHODS: In a retrospective study of the year 2012, all patients suffering from odontogenic infections were included. Demographic data, diagnosis and the conducted treatment were analyzed. Odontogenic infections were defined as pulpitis, apical and marginal periodontitis, abscesses and pericoronitis. RESULTS: A total of 2,058 out of 4,209 emergency patients suffered from odontogenic infections. The majority (45.0%) had an apical periodontitis, 20.8% abscesses, 17.3% a marginal periodontitis, 16.3% a pulpitis and 5.8% a pericoronitis. Mean age was 37.5 ± 17.0 years standard deviation (SD) (1.2-96.4). Most patients were 20 to 29 years (24.6%), followed by the age group of 30 to 39 year old patients (21.0%). Males were affected more frequently (55.5%) than females (45.5%). Most of the patients (64.5%) of the patients received a dental or surgical treatment. Antibiotics were prescribed in 31.7% of cases. Amoxicillin was the most common prescribed antibiotic (54.5%). CONCLUSION: Odontogenic infections represent one of the main reasons for consulting the emergency service. Due to the high number of cases and the severe complications, dentists have to be familiar with the surgical management of odontogenic infections as well as the appropriate use of antibiotics. CLINICAL SIGNIFICANCE: Nearly half of all patients who sought, treatment in the emergency service had an odontogenic infectious disease. This should be considered for the organization and planning of the service.

The Use of a Soft Tissue Substitute at Immediate Postextractive Implants to Reduce Tissue Shrinkage: One-Year Results from a Randomized Controlled Trial.

The aim of this randomized controlled trial (RCT) was to evaluate whether placement of a soft tissue graft substitute (STGS) could decrease peri-implant tissue shrinkage at immediate postextractive implants. Twenty patients with one missing tooth between two adjacent healthy teeth in esthetic areas and at least 4 mm of bone apical to the tooth apex were randomly allocated (after tooth extraction) to receive (n = 10; test group) or not receive (n = 10; control group) a subepithelial buccal STGS. Implants were inserted with a torque of at least 30 Ncm, and sites were grafted with a cancellous particulate allograft. All patients were restored with nonoccluding immediate provisional screw-retained crowns, replaced after 6 months by definitive metal-ceramic crowns. One year after loading, no dropouts, crown or implant failure, or complications occurred. No statistically significant difference or trends in volume shrinkage, esthetics, peri-implant marginal bone loss, and keratinized mucosa heights between the two groups were observed. Acknowledging that the sample size was small, no clinical benefit could be observed for the use of a STGS in immediate postextractive implants.

Undergraduate Students' Acceptance of a Reciprocating One-File System for Endodontic Treatment.

OBJECTIVES: Reciprocating endodontic one-file systems are a comparatively new method for root canal shaping. Even though the mechanical properties are comparable to modern rotating mechanical systems, data about subjective assessment and application quality are scarce. This study evaluates the reciprocating one-file system in undergraduate education. MATERIALS AND METHODS: A total of 42 undergraduate students without experience regarding reciprocating file systems filled in a questionnaire in four different points in time (t 1-t 4) anonymously. The questionnaire was based on a numerical rating scale ranging from 0 to 10. STATISTICAL ANALYSIS: A least significant difference post-hoc analysis comparing the group average values was performed. The adjusted level of significance was p < 0.004 after Bonferroni correction. RESULTS: All rating scores increased after the first theoretical instruction. After the first practical training in artificial root canals in resin blocks and extracted teeth (t 2), the estimation of "time efficiency" (p = 0.002), "handling" (p < 0.001), and "overall impression" (p < 0.001) improved significantly. The "overall impression" remained constant and showed no significant changes after the first practical training. CONCLUSIONS: Reciprocating systems seem to show a good acceptance among first time users. Initial concerns about "work safety" decrease during every step of the educational process. Reciprocating one-file systems are a safe and well-accepted method in undergraduate teaching.

Three-dimensional histochemistry and imaging of human gingiva.

In the present study, 3D histochemistry and imaging methodology is described for human gingiva to analyze its vascular network. Fifteen human gingiva samples without signs of inflammation were cleared using a mixture of 2-parts benzyl benzoate and 1-part benzyl alcohol (BABB), after being immunofluorescently stained for CD31, marker of endothelial cells to visualize blood vessels in combination with fluorescent DNA dyes. Samples were imaged in 3D with the use of confocal microscopy and light-sheet microscopy and image processing. BABB clearing caused limited tissue shrinkage 13 ± 7% as surface area and 24 ± 1% as volume. Fluorescence remained intact in BABB-cleared gingiva samples and light-sheet microscopy was an excellent tool to image gingivae whereas confocal microscopy was not. Histochemistry on cryostat sections of gingiva samples after 3D imaging validated structures visualized in 3D. Three-dimensional images showed the vascular network in the stroma of gingiva with one capillary loop in each stromal papilla invading into the epithelium. The capillary loops were tortuous with structural irregularities that were not apparent in 2D images. It is concluded that 3D histochemistry and imaging methodology described here is a promising novel approach to study structural aspects of human gingiva in health and disease.

A survey of clearing techniques for 3D imaging of tissues with special reference to connective tissue.

For 3-dimensional (3D) imaging of a tissue, 3 methodological steps are essential and their successful application depends on specific characteristics of the type of tissue. The steps are 1° clearing of the opaque tissue to render it transparent for microscopy, 2° fluorescence labeling of the tissues and 3° 3D imaging. In the past decades, new methodologies were introduced for the clearing steps with their specific advantages and disadvantages. Most clearing techniques have been applied to the central nervous system and other organs that contain relatively low amounts of connective tissue including extracellular matrix. However, tissues that contain large amounts of extracellular matrix such as dermis in skin or gingiva are difficult to clear. The present survey lists methodologies that are available for clearing of tissues for 3D imaging. We report here that the BABB method using a mixture of benzyl alcohol and benzyl benzoate and iDISCO using dibenzylether (DBE) are the most successful methods for clearing connective tissue-rich gingiva and dermis of skin for 3D histochemistry and imaging of fluorescence using light-sheet microscopy.

Antimicrobial photodynamic therapy using diode laser activated indocyanine green as an adjunct in the treatment of chronic periodontitis: A randomized clinical trial.

INTRODUCTION: Clinical studies have shown the usefulness of antimicrobial photodynamic therapy (aPDT) as an adjunctive in periodontal therapy. These studies did not utilize indocyanine green (ICG) as a recently introduced photosensitizer. The aim of this study was to perform a full-mouth double-blind randomized controlled clinical study to test the efficacy of adjunctive aPDT with ICG compared with scaling and root planing (SRP) alone in chronic periodontitis treatment. MATERIALS AND METHODS: Fifty patients were selected for this study. All patients received SRP. Then, each patient was randomly assigned to either the test group (aPDT+SRP) or the control group (SRP). aPDT was performed with a diode laser (wavelength: 810nm, power: 200mW) and ICG as photosensitizer. The adjunctive procedure was repeated after 7, 17 and 27 days. The clinical parameters including bleeding on probing (BOP), clinical attachment loss (CAL), plaque index (PI), probing pocket depth (PPD), full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) were measured at baseline and after 1 and 3 months. RESULTS: There were no significant differences between two groups at baseline. BOP, PPD and FMBS showed significant improvements in the test group (P≤0.001). In terms of PI, FMPS and CAL, no significant differences were observed between both groups (P≥0.05). CONCLUSION: aPDT as an adjunctive approach yielded complete resolution of inflammation and significant reduction in periodontal pocket depth. However, aPDT had no additional advantages in clinical attachment gain and plaque score.

Epidemiological investigation of caries prevalence in first grade school children in Rhineland-Palatinate, Germany.

INTRODUCTION: The annual examination of first graders' oral health as stipulated by law aimed to reach every child in Rhineland-Palatinate (Germany) in their first year of school. We intended to evaluate the first graders' oral health based on the examination data for 2013/2014. METHODS: Instructed examiners measured the d3mft(deciduous)/D3MFT(permanent) index according to World Health Organization criteria in 25,020 predominantly 6-7 year-old first-grade school children. Only caries affecting dentin was diagnosed; no radiography or fiber-transillumination was used. Out of the d3mft value, the "Significant Caries Index" (SiC) was calculated. This index identifies the dmft score of the third of the population with the highest caries experience. Descriptive analysis was performed. RESULTS: Out of the the examined children, 60.9% were caries free. Mean d3mft score was 1.28 ± 2.27 while the mean SiC was 3.73 ± 2.51. A distinctly higher d3mft was found in the decidous molars compared to the front teeth. Boys were significantly more caries-experienced than girls (p < 0.001). CONCLUSION: The results of this study confirm the lasting trend towards decreasing caries prevalence in children starting school found in previous cross-sectional studies. This trend was observed in the high-risk group (obtained by SiC) as well as in the entire study population. Particular attention in caries prophylaxis should be paid to the primary molars.

Post-endodontic treatment periodontal surgery: a case report.

Two patients were diagnosed with combined endodontic-periodontal lesions. Endodontic treatment was performed, followed by surgery. In addition, the regeneration process was supported by the application of an enamel matrix derivate alone or in combination with guided bone regeneration techniques. At recall visits after 24 months, the teeth were asymptomatic and marked bone regeneration had occurred in both patients. The successful post-endodontic treatment of combined endodontic-periodontal lesions, using periodontal surgery and as adjunct guided tissue regenerative techniques, is presented. Further, the possibility of saving teeth, even with severely apparent pathology, should be highlighted.

A prospective clinical trial on the influence of a triamcinolone/demeclocycline and a calcium hydroxide based temporary cement on pain perception.

INTRODUCTION: The aim of this clinical trial was to compare the degree of short term post-operative irritation after application of a triamcinolone/demeclocycyline based or a calcium hydroxide based provisional cement. METHODS: A total of 109 patients (55 female and 54 male; mean age: 51 ± 14 years) with primary or secondary dentinal caries were randomly assigned to the two treatment groups of this biomedical clinical trial (phase III). Selection criteria were good systemic health and treated teeth, which were vital and showed no symptoms of pulpitis. Up to three teeth were prepared for indirect metallic restorations, and the provisional restorations were cemented with a triamcinolone/demeclocycyline (Ledermix) or a calcium hydroxide (Provicol) based material. The intensity of post-operative pain experienced was documented according to the VAS (4, 12, 20, 24, and 82 h) and compared to VAS baseline. RESULTS: A total of 159 teeth were treated (Ledermix: 83 teeth, Provicol: 76 teeth). The minor irritation of the teeth, experienced prior to treatment, was similar in both groups; however, 4 h after treatment this value was significantly higher in the Provicol group than in the Ledermix group (p < 0.005, t-test). After 12 h, the difference was no longer significant. The number of patients taking analgesics for post-treatment pain was higher in the Provicol group (n = 11/53) than in the Ledermix group (n = 3/56). CONCLUSIONS: The patients had no long term post-operative pain experience in both groups. However, within the first hours after cementation the sensation of pain was considerably higher in the Provicol group than in the Ledermix group.