The Effect of Enamel Matrix Derivatives on Root Coverage Esthetic Score

Periodontal Diseases Clinical Trial

Official title:

The Effect of Enamel Matrix Derivatives on Root Coverage Esthetic Score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197610
• Other study ID #: B.30.2.YYU.0.01.00.0
• Status: Completed
• Phase: N/A
• First received: June 15, 2017
• Last updated: June 20, 2017
• Start date: January 1, 2015
• Est. completion date: September 1, 2016

Study information

• Verified date: June 2017
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subepithelial connective tissue grafts (SCTG) are accepted as the gold standard in covering denuded root surfaces. Combining enamel matrix derivatives (EMD) with periodontoplasic surgical operations is another method in covering denuded root surface. The aim of this study is to compare a SCTG operation group and EMD applied group in addition to SCTG using complete root coverage rate and a newer method root coverage esthetic scoring system (RES).

Description:

Background: Subepithelial connective tissue grafts (SCTG) are accepted as the gold standard in covering denuded root surfaces. Combining enamel matrix derivatives (EMD) with periodontoplasic surgical operations is another method in covering denuded root surface. The aim of this study is to compare a SCTG operation group and EMD applied group in addition to SCTG using complete root coverage rate and a newer method root coverage esthetic scoring system (RES).

Methods: This is a split-mouth and controlled study. Thirthy-eight Class I or II gingival recession defects at canine teeth were treated in the control (SCTG) (n=19) and test groups (n=19) (SCTG+EMD). The root coverage esthetic score were evaluated by 2 blind periodontists 1 year after the treatment using RES. The agreement between the two periodontists was assessed by kappa analysis. Complete root coverage rate was evaluated for both groups. Two groups were compared with statistically methods in terms of RES parameters and gingival recession height /width.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The patient had no systemic disease, did not smoke cigarette and tobacco products, did not have a pregnancy and breastfeeding period, had class I and class II gingival recession according to the Miller gingival classification, had a recession depth of =2 mm, have not had a restoration and have had an operation in the relevant dental region that had no previous gingival surgical procedure were included in this study.

Exclusion Criteria:

• systemic disease

• multiple gingival recession

• miller class III and IV recessions were excluded

Related Conditions & MeSH terms

• Gingival Diseases
• Gingival Recession
• Periodontal Diseases

Intervention

Procedure:
• enamel matrix derivatives
enamel matrix derivatives and subepithelial connective tissue grafts

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	root coverage percentage	root coverage percentage of denuded root surface	1 year
Primary	root coverage aesthetic score	root coverage aesthetic score of treatment modalities	1 year