Surgical Treatment of Gingival Recessions

Micro and Macrosurgical Treatment of Gingival Recessions: a Randomized Clinical Trial

The purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects (Miller class I or II) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the postoperative complaints and satisfaction levels of the patients. We hypothesized that root coverage achieved through microsurgery in Miller I or II gingival recessions would improve clinical periodontal outcomes and the periodontal phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with conventional macrosurgical techniques. Miller Class I and II gingival recession defects, at least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical techniques. Both techniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. Plaque and gingival indices, gingival recession depth and width, probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, aesthetic score and percentage of root coverage, postoperative complaints, and satisfaction of the participants completing the study were evaluated at follow-up 1st, 3rd and 6th months.

Study Overview

• Status: Completed
• Conditions: Gingival Recession; Clinical Trial; Microsurgery; Connective Tissue
• Intervention / Treatment: Procedure: surgical techniques in the treatment of localized gingival recession defects.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

-

All participants were:

• adults aged 18 years or over
• systemically and periodontally healthy
• met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the Miller classification scheme

Exclusion Criteria:

-

Exclusion criteria included the following:

• medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis;
• a history of chemotherapy or radiotherapy;
• a history of alcoholism or drug abuse;
• a history of previous mucogingival surgery at the gingival recession site;
• medications known to affect gingival tissues;
• antibiotic treatment in the past 6 months;
• smoking >10 cigarettes per day for >5 years, and;
• current pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microsurgery group; All defects were treated with a CPF plus an SCTG by the same investigator using microsurgery technique.	Procedure: surgical techniques in the treatment of localized gingival recession defects.; Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.
Active Comparator: Macrosurgery group; All defects were treated with a CPF plus an SCTG by the same investigator using macrosurgery technique.	Procedure: surgical techniques in the treatment of localized gingival recession defects.; Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of root coverage	The primary endpoint for efficacy of the gingival recession was the percentage of root coverage at baseline and 6-months postsurgery, as measured by gingival recession depth.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gingival recession depth		6 months
Changes in Gingival recession width		6 months
Changes in Keratinized gingival width		6 months
visual analog scale	A visual analog scale was used to evaluate postoperative complaints regarding the recipient and donor sites according to graft size and postoperative satisfaction values (level of the gingival margin, gingival tissue color, dentin hypersensitivity, and root coverage) during the follow-up period. A 10 cm VAS, with "none" / "unhappy" at the left end and "unbearable" / "happy" at the right end was prepared for each patient.	6 months

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Collaborators: Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: Mamtograrct

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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