Comparison of Enamel Matrix Derivatives (EMD) to EMD/Decalcified Freezed Dried Bone Allograft (DFDBA) in the Treatment of Human Intrabony Periodontal Defects: A Controlled Clinical Trial With 6 Month Re-entry
The aim of this study was to compare the enamel matrix derivative (EMD) alone to EMD combined with decalcified freezed dried bone allograft (EMD/DFDBA) in the treatment of human periodontal defects.
Using a randomized split-mouth design, 18 paired intrabony defects were surgically treated either with EMD (EMD group) or EMD+DFDBA (EMD/DFDBA group). Surgical reentries were performed 6 months after initial surgery .A wilcoxon signed-rank test and Mann –whitney U test were used to compare inter and intra group changes (respectively) in clinical probing depth (CPD), clinical attachment level (CAL), gingival recession (GR), bony defect fill (DF), crestal resorption(CR) and defect resolution (DR)between baseline and 6 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020710501N2
Registration date:2013-03-22, 1392/01/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-22, 1392/01/02
Registrant information
Name
Nader Abolfazli
Name of organization / entity
Departyment of periodontics, Tabriz faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
abolfazli@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of medical sciences
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2008-03-19, 1386/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Enamel Matrix Derivatives (EMD) to EMD/Decalcified Freezed Dried Bone Allograft (DFDBA) in the Treatment of Human Intrabony Periodontal Defects: A Controlled Clinical Trial With 6 Month Re-entry
Public title
Treatment of intrabony defects
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were the presence of paired interproximal 2 or 3 wall vertical defects ≥3mm deep (distance between alveolar crest and base of the defect in intraoral periapical radiography) along with an interproximal probing depths ≥5.0 mm following initial non-surgical therapy. The patient exclusion criteria consisted of : 1) known systemic diseases and/or drug therapy known to interfere with wound healing; 2) compromised immune system; 3) pregnancy and\ or lactation; 4) cigarette smoking; 5) using systemic antibiotics or having received antibiotic therapy in the last 3 months; and 6) O´Leary plaque score>20%.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of medical sciences
Street address
Golgasht AVE
City
Tabriz
Postal code
5165685471
Approval date
2012-12-31, 1391/10/11
Ethics committee reference number
91162
Health conditions studied
1
Description of health condition studied
periodontal disease
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Bony defect fill
Timepoint
Baseline and 6 month later
Method of measurement
periodontal probe
2
Description
Bony defect fill
Timepoint
Baseline and 6 month later
Method of measurement
periodontal probe
Secondary outcomes
1
Description
Clinical Attachment level
Timepoint
baseline and 6 month later
Method of measurement
periodontal probe
2
Description
Gingival recession
Timepoint
baseline and 6 month later
Method of measurement
periodontal probe
3
Description
clinical probing depth
Timepoint
baseline and 6 month later
Method of measurement
periodontal probe
Intervention groups
1
Description
Using EMD alone in the treatment of intrabony defects (control group)
Category
Treatment - Surgery
2
Description
Using EMD /DFDBA in the treatment of intrabony defects (Test group)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of medical sciences
Full name of responsible person
Nader Abolfazli
Street address
Tabriz University of medical sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
No 2, Central building , Daneshgah street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental faculty, Tabriz University of medice sciences
Full name of responsible person
Nader Abolfazli
Position
Associated professor
Other areas of specialty/work
Street address
Dental faculty,Tabriz University of medice sciences
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
abolfazli@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz dental faculty
Full name of responsible person
Nader Abolfazli
Position
periodontist
Other areas of specialty/work
Street address
Tabriz dental faculty, periodontics department
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
abolfazli@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz dental faculty
Full name of responsible person
Nader Abolfazli
Position
Associated professor
Other areas of specialty/work
Street address
Tabriz dental faculty
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
abolfazli@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)