The effectiveness of a resorbable bone substitute with a resorbable membrane in the treatment of periodontal infrabony defect - A multicenter randomised controlled trial.
OBJECTIVE
To evaluate the effectiveness of a bone substitute covered with a resorbable membrane versus open flap debridement for the treatment of periodontal infrabony defects.


METHODS
Ninety-seven patients with one infrabony defect, which was 3 mm or deeper and at least 2 mm wide were randomly allocated either to grafting with a bone substitute covered with a resorbable barrier (BG group) or open flap debridement (OFD group) according to a parallel group design in five European centres. Blinded outcome measures assessed tooth loss, complications, patient's satisfaction with treatment and aesthetics, changes in probing attachment levels (PAL), probing pocket depths (PPD), gingival recessions (REC), radiographic bone levels (RAD) on standardised periapical radiographs, plaque index (PI) and marginal bleeding index (MBI).


RESULTS
49 patients were randomly allocated to the BG group and 48 to the OFD group. At baseline there were more mobile teeth in the BG group (29 versus 15). One year after treatment two patients dropped out from the BG group and no teeth were lost. Three complications (minor postoperative wound dehiscence) occurred in the BG group versus none in the OFD group, where the difference was not statistically significant. The BG group obtained significantly greater statistical PAL gain (mean difference = -0.8 mm, 95% CI [-1.51; -0.03], P = 0.0428), PPD reduction (mean difference = -1.1 mm, 95% CI [-1.84; -0.19], P = 0.0165) and RAD gain (mean difference = -1.2 mm, 95% CI [-2.0; -0.4], P = 0.0058) compared to the OFD group. No statistically significant differences between the groups were observed for gingival recession, or the patient's satisfaction with the treatment and aesthetics. There were some statistically significant differences between the centres for PAL and PPD with the Italian centres reporting better outcomes.


CONCLUSIONS
The use of a bone substitute covered with a resorbable membrane yielded significantly better statistical clinical outcomes than open flap debridement in the treatment of periodontal infrabony defects deeper than 3 mm, with regard to PAL gain, PPD reduction and RAD gain.
Marco
M
Esposito
Maria Gabriella
MG
Grusovin
France
F
Lambert
Sérgio
S
Matos
Małgorzata
M
Pietruska
Roberto
R
Rossi
Leila
L
Salhi
Jacopo
J
Buti
D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D016301:Alveolar Bone Loss / Q000601:surgery*; D000539:Alveolar Process / Q000000981:diagnostic imaging; D018786:Bone Substitutes / Q000627:therapeutic use*; D003646:Debridement / Q000379:methods; D004955:Esthetics, Dental; D005260:Female; D005500:Follow-Up Studies; D005889:Gingival Recession / Q000145:classification; D016557:Guided Tissue Regeneration, Periodontal / Q000379:methods*; D006801:Humans; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D017060:Patient Satisfaction; D017622:Periodontal Attachment Loss / Q000145:classification; D010514:Periodontal Pocket / Q000145:classification; D011183:Postoperative Complications; D011859:Radiography; D016037:Single-Blind Method; D013524:Surgical Flaps / Q000601:surgery; D013529:Surgical Wound Dehiscence / Q000209:etiology; D016388:Tooth Loss / Q000209:etiology; D016896:Treatment Outcome; D055815:Young Adult
D018786:Bone Substitutes; D008567:Membranes, Artificial