The Effect of Enamel Matrix Derivatives on Root Coverage Esthetic Score

NCT03197610 | Completed

• 1 other identifier: B.30.2.YYU.0.01.00.0
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Gingival Recession; Periodontal Diseases

Keywords

gingival recession; sub epithelial connective tissue graft; enamel matrix derivatives; root coverage aesthetic score

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

SCTG+EMD

EXPERIMENTAL

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

ONLY SCTG

EXPERIMENTAL

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

Interventions

enamel matrix derivatives PROCEDURE

enamel matrix derivatives and subepithelial connective tissue grafts

ONLY SCTG; SCTG+EMD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• systemic disease
• multiple gingival recession
• miller class III and IV recessions were excluded

Sponsors & Collaborators

• Yuzuncu Yil University: lead

MeSH Terms

Conditions

Gingival Recession; Periodontal Diseases

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 23, 2017
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share