The Effect of Enamel Matrix Derivatives on Root Coverage Esthetic Score

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).

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Gingival Recession
• Intervention / Treatment: Procedure: enamel matrix derivatives

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: enamel matrix derivatives; enamel matrix derivatives and subepithelial connective tissue grafts
EXPERIMENTAL: 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.	Procedure: enamel matrix derivatives; enamel matrix derivatives and subepithelial connective tissue grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
root coverage percentage	root coverage percentage of denuded root surface	1 year
root coverage aesthetic score	root coverage aesthetic score of treatment modalities	1 year

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (ACTUAL): June 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: gingival recession; sub epithelial connective tissue graft; enamel matrix derivatives; root coverage aesthetic score
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession; Periodontal Diseases
• Other Study ID Numbers: B.30.2.YYU.0.01.00.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No