Enamel matrix derivative in the treatment of human intrabony osseous defects.
BACKGROUND
There is limited information available from clinical trials regarding the performance of enamel matrix derivative (EMD) in the treatment of periodontal intrabony defects. This randomized, double-blind, placebo-controlled, split-mouth study was designed to compare the clinical and radiographical effects of EMD treatment to that of placebo-controlled treatment for intrabony defects.


METHODS
Sixteen patients were included, each of whom had 1 or 2 pairs of intrabony defects located contralaterally in the same arch. Thirty-six intrabony defects were randomly assigned treatment with flap surgery plus EMD or flap surgery plus placebo. At baseline and at the 12-month follow-up evaluation visit, clinical and radiographic measurements were determined. Data were statistically analyzed using the Wilcoxon-signed rank test (alpha = 0.05).


RESULTS
At the 12-month visit, bleeding on probing for the EMD group was 0.11 +/- 0.32 compared to the placebo group, 0.61 +/- 0.50 (P <0.05). Probing depth reduction was greater in the EMD group (3.00 +/- 0.97 mm) compared to the placebo group (2.22 +/- 0.81 mm) (P <0.05). Mean values for clinical attachment gain in the EMD and the placebo groups were 1.72 +/- 1.07 mm and 0.83 +/- 0.86 mm, respectively (P <0.05). Vertical relative attachment gain was 38.5 +/- 22.6% in the EMD group and 21.4 +/- 25.2% in the placebo group (P<0.05). Radiographic bone density gain was greater in the EMD (20.2 +/- 16.6%) compared to the placebo group (-3.94 +/- 23.3%) (P<0.01).


CONCLUSIONS
Treatment with flap surgery and EMD, compared to flap surgery with placebo, produced a significantly more favorable clinical improvement in intrabony periodontal defects.
Okuda
K
K
Department of Periodontology, Faculty of Dentistry, Niigata University, Japan. okuda@dent.niigata-u.ac.jp
Momose
M
M
Miyazaki
A
A
Murata
M
M
Yokoyama
S
S
Yonezawa
Y
Y
Wolff
L F
LF
Yoshie
H
H
D000328:Adult; D016301:Alveolar Bone Loss / Q000000981:diagnostic imaging / Q000601:surgery*; D000539:Alveolar Process / Q000000981:diagnostic imaging; D015519:Bone Density; D018786:Bone Substitutes / Q000627:therapeutic use*; D003746:Dental Enamel Proteins / Q000627:therapeutic use*; D003774:Dental Plaque Index; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000601:surgery; D016557:Guided Tissue Regeneration, Periodontal / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D017622:Periodontal Attachment Loss / Q000601:surgery; D010512:Periodontal Index; D010514:Periodontal Pocket / Q000601:surgery; D010518:Periodontitis / Q000000981:diagnostic imaging / Q000601:surgery; D010919:Placebos; D011859:Radiography; D018709:Statistics, Nonparametric; D013524:Surgical Flaps
D018786:Bone Substitutes; D003746:Dental Enamel Proteins; D010919:Placebos; C109069:enamel matrix proteins