Surgical Treatment of Gingival Recessions

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611282
• Other study ID #: Mamtograrct
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: September 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Trial
• Connective Tissue
• Gingival Recession
• Microsurgery

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital	Kocaeli University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Gingival recession depth		6 months
Secondary	Changes in Gingival recession width		6 months
Secondary	Changes in Keratinized gingival width		6 months
Secondary	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