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OpenTrials
Completed

NCT Number: NCT04611282

Surgical Treatment of Gingival Recessions

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

surgical techniques in the treatment of localized gingival recession defects.

Procedure

Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.

Primary outcomes

  1. Percentage of root coverage

    Time frame: 6 months

    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.

Secondary outcomes

  1. Changes in Gingival recession depth

    Time frame: 6 months

  2. Changes in Gingival recession width

    Time frame: 6 months

  3. Changes in Keratinized gingival width

    Time frame: 6 months

  4. visual analog scale

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Collaborators

  • Kocaeli University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2020
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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