Clinical outcomes following treatment of human intrabony defects with GTR/bone replacement material or access flap alone. A multicenter randomized controlled clinical trial.

AIM: This prospective multicenter randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of a guided tissue regeneration (GTR)/bone replacement material. MATERIALS AND METHODS: One hundred and twenty-four patients with advanced chronic periodontitis were recruited in 10 centers in seven countries. All patients had at least one intrabony defect of > or = 3 mm. The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure. After debridement, the regenerative material was applied in the test subjects, and omitted in the controls. At baseline and 1 year following the interventions, clinical attachment levels (CALs), probing pocket depths (PPDs), recession, full-mouth plaque scores and full-mouth bleeding scores (FMBS) were assessed. RESULTS: One year after treatment, the test defects gained 3.3 +/- 1.7 mm of CAL, while the control defects yielded a significantly lower CAL gain of 2.5 +/- 1.5 mm. Pocket reduction was also significantly higher in the test group (3.7 +/- 1.8 mm) when compared with the controls (3.2 +/- 1.5 mm). A multivariate analysis indicated that the treatment, the clinical centers, baseline PPD and baseline FMBS significantly influenced CAL gains. Odds ratios (ORs) of achieving above-median CAL gains were significantly improved by the test procedure (OR = 2.6, 95% CI 1.2-5.4) and by starting with deeper PPD (OR = 1.7, 1.3-2.2) but were decreased by receiving treatment at the worst-performing clinical center (OR = 0.9, 0.76-0.99). CONCLUSIONS: The results of this trial indicated that regenerative periodontal surgery with a GTR/bone replacement material offers an additional benefit in terms of CAL gains, PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone.

Patient evaluation of a novel non-injectable anesthetic gel: a multicenter crossover study comparing the gel to infiltration anesthesia during scaling and root planing.

BACKGROUND: Periodontal scaling procedures commonly require some kind of anesthesia. From the patient's perspective, the choice of anesthetic method is a trade-off between the degree of anesthesia and accepting the side effects. The present study evaluates the preferences for a novel non-injection anesthetic product (a gel, containing lidocaine 25 mg/g plus prilocaine 25 mg/g and thermosetting agents) versus injection anesthesia (lidocaine 2% adrenaline) in conjunction with scaling and/or root planing (SRP). METHODS: In a multicenter, crossover, randomized, open study patients were asked, after they had experienced both products, if they preferred anesthetic gel or injection anesthesia. In addition, the adequacy of anesthesia and occurrence of post-procedure problems were assessed. The patients were also asked about their willingness to return if they were offered anesthetic gel at their next visit and their maximum willingness to pay (WTP) for this option. RESULTS: One-hundred seventy (170) patients at eight centers in Belgium were included in the study. There were 157 per protocol (PP) patients. A vast majority of the PP patients (70%) preferred the anesthetic gel to injection anesthesia (22%). The most common reason was less post-procedure numbness. Eighty percent (80%) of the patients expressed satisfactory anesthesia with the gel and 96% with injection anesthesia (P <0.001). Post-procedure problems were significantly less with the gel than with injection (P <0.001): numbness 15% versus 66%, unpleasant sensations such as soreness and pain 44% versus 63%, and problems connected with daily activities 19% versus 69%. The majority of patients (60%) who preferred gel were also willing to pay for it. A conservative estimate of the median WTP was $10.00. Furthermore, anesthetic gel would make almost every second patient (45%) more or much more willing to return for the next treatment. CONCLUSIONS: The data suggest that a somewhat less profound anesthesia with gel is clearly preferred by the patients because of the low incidence of post-procedure problems as compared to conventional injection anesthesia. The median WTP is likely in excess of the acquisition cost of the product, which indicates a favorable cost-benefit ratio for the individual patient.

Healing of human extraction sockets filled with Bio-Oss.

The aim of this study was to investigate the healing of human extraction sockets filled with Bio-Oss particles (Geistlich Pharma AG, Wolhusen, Switzerland). In 21 subjects, providing a total of 31 healing sites, at least one tooth was scheduled for extraction and the extraction sites for implant therapy. The dimensions of the alveolar ridge at the extraction sites were considered insufficient and required augmentation concomitant with tooth extraction. There were three treatment groups. In group A, the extraction sockets were covered with a Bio-Gide membrane (Geistlich Pharma AG) and in group B the extraction sockets were filled with Bio-Oss. The extraction sockets in group C were left to heal spontaneously. Biopsies from the extraction sites were collected at the time of implant installation. Samples from group A showed large amounts of lamellar bone and bone marrow and small proportions of woven bone. Sites grafted with Bio-Oss (group B) were comprised of connective tissue and small amounts of newly formed bone surrounding the graft particles. Only 40% of the circumference of the Bio-Oss particles was in contact with woven bone. Sites from group C were characterized by the presence of mineralized bone and bone marrow.

Enamel matrix proteins in the regenerative therapy of deep intrabony defects.

AIM: This prospective multicentre randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of enamel matrix proteins (EMD). MATERIAL AND METHODS: 172 patients with advanced chronic periodontitis were recruited in 12 centers in 7 countries. All patients had at least one intrabony defect of > or =3mm. Heavy smokers (> or =20 cigarettes/day) were excluded. The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure. After debridement, roots were conditioned for 2 min with a gel containing 24% EDTA. EMD was applied in the test subjects, and omitted in the controls. Postsurgically, a strict plaque control protocol was followed. At baseline and 1 year following the interventions, clinical attachment levels (CAL), pocket probing depths (PPD), recession (REC), full-mouth plaque scores and full-mouth bleeding scores were assessed. A total of 166 patients were available for the 1-year follow-up. RESULTS: At baseline, 86 test and 86 control patients presented with similar subject and defect characteristics. On average, the test defects gained 3.1+/-1.5 mm of CAL, while the control defects yielded a significantly lower CAL gain of 2.5+/-1.5 mm. Pocket reduction was also significantly higher in the test group (3.9+/-1.7 mm) when compared to the controls (3.3+/-1.7 mm). A multivariate analysis indicated that the treatment, the clinical centers, cigarette smoking, baseline PPD, and defect corticalisation significantly influenced CAL gains. A frequency distribution analysis of the studied outcomes indicated that EMD increased the predictability of clinically significant results (CAL gains > or =4 mm) and decreased the probability of obtaining negligible or no gains in CAL (CAL gains <2 mm). CONCLUSIONS: The results of this trial indicated that regenerative periodontal surgery with EMD offers an additional benefit in terms of CAL gains, PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone.