Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter practice-based clinical trial.
BACKGROUND
This prospective multicenter, randomized, controlled clinical trial compared the clinical outcomes of enamel matrix proteins (EMD) versus placement of a bioabsorbable membrane in conjunction with guided tissue regeneration (GTR).


METHODS
Seventy-five patients with advanced chronic periodontitis were recruited in seven centers in three countries. All patients had at least one intrabony defect of > or = 3 mm. Heavy smokers (> or = 20 cigarettes/day) were excluded. The surgical procedures included access for root instrumentation using the simplified papilla preservation flap and either the application of EMD or the placement of a GTR membrane. At baseline and 1 year following the interventions, clinical attachment levels (CAL), probing depths (PD), recession (REC), full-mouth plaque scores, and full-mouth bleeding scores were assessed. A total of 67 patients completed the study.


RESULTS
At 1 year, the EMD defects gained 3.1 +/- 1.8 mm of CAL, versus 2.5 +/- 1.9 mm for GTR defects. Probing depth reduction was 3.8 +/- 1.5 mm and 3.3 +/- 1.5 mm, respectively. A multivariate analysis indicated that the differences between EMD and GTR treatments were not significant while a center effect and baseline PD significantly influenced CAL gains. No significant differences in terms of frequency distribution of the outcomes were observed. All cases treated with GTR presented at least one surgical complication, mostly membrane exposure, while only 6% of EMD treated sites displayed complications (P < 0.0001).


CONCLUSIONS
The results of this trial failed to demonstrate superiority of one treatment modality over the other. GTR outcomes in this trial were lower than anticipated based on previous evidence. This was attributed to the high prevalence of post-surgical complications in the GTR group.
Sanz
Mariano
M
Department of Periodontology, University Complutense, Madrid, Spain. marianosanz@odon.ucm.es
Tonetti
Maurizio S
MS
Zabalegui
Ion
I
Sicilia
Alberto
A
Blanco
Juan
J
Rebelo
Helena
H
Rasperini
Giulio
G
Merli
Mauro
M
Cortellini
Pierpaolo
P
Suvan
Jean E
JE
D020341:Absorbable Implants; D000328:Adult; D016301:Alveolar Bone Loss / Q000601:surgery; D002908:Chronic Disease; D003746:Dental Enamel Proteins / Q000627:therapeutic use*; D003774:Dental Plaque Index; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000601:surgery; D005889:Gingival Recession / Q000601:surgery; D016557:Guided Tissue Regeneration, Periodontal / Q000379:methods*; D006801:Humans; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D017622:Periodontal Attachment Loss / Q000601:surgery; D010514:Periodontal Pocket / Q000601:surgery; D010518:Periodontitis / Q000601:surgery; D011446:Prospective Studies; D016896:Treatment Outcome
D003746:Dental Enamel Proteins; D008567:Membranes, Artificial; C109069:enamel matrix proteins