The Effect of Enamel Matrix Derivatives on Root Coverage Esthetic Score

NCT ID: NCT03197610

Last Updated: 2017-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2016-09-01

Brief 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).

Detailed 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.

Conditions

Gingival Recession; Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SCTG+EMD

TEST GROUP: Langer and Langer technique was used to prepare the recipient side. The vestibule surfaces of adjacent interdental papillae were de-epithelialized. The dimensions of the recipient area were measured by periodontal probes and four bleeding centers were created in the palatinal region. The graft was placed on the recipient site and fixed with 4.0 silk sutures. Pressure was applied to the operation area for 5 minutes with saline impregnated sponges. EMD (Emdogain®, Straumann, Basel, Switzerland) was used in the test group in addition to SCTG. Prior to EMD application, the root surface was applied with 24% EDTA (PrefGel, Straumann, Basel, Switzerland) for 2 minutes. The area was washed with saline and then EMD was applied.

Group Type: EXPERIMENTAL

enamel matrix derivatives

Intervention Type: PROCEDURE

enamel matrix derivatives and subepithelial connective tissue grafts

ONLY SCTG

CONTROL GROUP: Langer and Langer technique was used to prepare the recipient side. The anesthetic solution was applied to the donor site in the palatinal region on the same side as the operation site. The dimensions of the recipient area were measured by periodontal probes and four bleeding centers were created in the palatinal region. The graft was placed on the recipient site and fixed with 4.0 silk sutures. Pressure was applied to the operation area for 5 minutes with saline impregnated sponges.

Group Type: EXPERIMENTAL

enamel matrix derivatives

Intervention Type: PROCEDURE

enamel matrix derivatives and subepithelial connective tissue grafts

Interventions

enamel matrix derivatives

enamel matrix derivatives and subepithelial connective tissue grafts

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Accepts Healthy Volunteers: No

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Hacer Sahin Aydinyurt

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

B.30.2.YYU.0.01.00.0

Identifier Type: -

Identifier Source: org_study_id