The Effect of Free Gingival Graft on Root Closure

NCT05604391 | Recruiting

• 1 other identifier: 2021-02/09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Free gingival graft is a mucogingival surgical technique applied to increase keratinized gingival width and reduce gingival recession. Free gingival graft is one of the most widely used approaches in root closure treatments and in increasing the height of the keratinized gingiva. Evaluation of the effect of the amount of creeping attachment on the root surface caused by the free gingival grafts placed coronally and apical to the mucogingival line on the gingival recession in the mandibular anterior region with keratinized gingival deficiency with gingival recession. Forty patients with gingival recession and insufficient keratinized gingival height will be randomly divided into 2 main groups as free gingival grafts to be placed coronal and apical to the gingival recession.

Conditions

Gingival Recession; Lack of Keratinized Gingiva

Keywords

free gingival grafts; creeping attachment; root closure; gingival recession

Outcome Measures

Primary Outcomes (1)

• 1. Percent closure of the gingival recession

  It is calculated by dividing the pre- and post-surgical values of the exposed root surface.

  Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month

Secondary Outcomes (3)

• 2. Keratinized mucosa width change

  Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month

• 3. Keratinized mucosa width thickness change

  Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month

• 4. Vestibular sulcus depth change

  Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month

Study Arms (2)

Free gingival grafts to be placed apical to the gingival recession.

ACTIVE COMPARATOR

It is the application of free gingival graft to the apical part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency.

Procedure: Free gingival graft placed apically

Free gingival grafts to be placed coronal to the gingival recession.

ACTIVE COMPARATOR

It is the application of free gingival graft to the coronal part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency.

Procedure: Free gingival graft placed coronally

Interventions

Free gingival graft placed apically PROCEDURE

For free gingival graft operation, the recipient area will be prepared with a half-thickness flap. A graft with a thickness of approximately 1.5 mm and a width and height of the recipient bed will be obtained from the palatal region in accordance with the recipient bed, and it will be sutured by placing it in the apical region of the gingival recession according to the randomly selected positioning technique.

Free gingival grafts to be placed apical to the gingival recession.

Free gingival graft placed coronally PROCEDURE

For free gingival graft operation, the recipient area will be prepared with a half-thickness flap. A graft with a thickness of approximately 1.5 mm and a width and height of the recipient bed will be obtained from the palatal region in accordance with the recipient bed, and it will be sutured by placing the coronal region of the gingival recession according to the randomly selected positioning technique.

Free gingival grafts to be placed coronal to the gingival recession.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• The patient does not have any systemic disease
• Presence of at least one tooth with gingival recession in the mandibular anterior region
• Excessive dentin sensitivity and impaired esthetics associated with recession
• Identification of the enamel-cementum boundary in the shrinkage region
• The tooth is alive and there are no irregularities, grooves, caries and restorations in the area to be treated.
• No periodontal surgical treatment in the relevant areas in the last 24 months
• Presence of adequate keratinized and attached gingiva in the donor area

You may not qualify if:

• Being outside the specified age range
• Any contraindication for systematic periodontal surgery
• Failure to define the enamel-cementum boundary in the withdrawal region
• Presence of caries, restoration, root concavity in the area to be treated
• Patients who smoke more than 10 cigarettes per day
• Patients who use drugs that suppress the immune system or impair recovery
• Patients using drugs that impair bleeding
• Insufficient keratinized and attached gingiva in the donor area

Sponsors & Collaborators

• Berceste Guler: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. J Clin Periodontol. 1980 Aug;7(4):316-24. doi: 10.1111/j.1600-051x.1980.tb01974.x.

  PMID: 6936409 BACKGROUND

• Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.

  PMID: 19722789 BACKGROUND

• Bell LA, Valluzzo TA, Garnick JJ, Pennel BM. The presence of "creeping attachment" in human gingiva. J Periodontol. 1978 Oct;49(10):513-7. doi: 10.1902/jop.1978.49.10.513.

  PMID: 282425 BACKGROUND

• Matter J, Cimasoni G. Creeping attachment after free gingival grafts. J Periodontol. 1976 Oct;47(10):574-9. doi: 10.1902/jop.1976.47.10.574.

  PMID: 1067400 BACKGROUND

• Gul SS, Zardawi FM, Sha AM, Rauf AM. Assessment of Creeping Attachment after Free Gingival Graft in Treatment of Isolated Gingival Recession. J Int Acad Periodontol. 2019 Jul 1;21(3):125-131.

  PMID: 31473705 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Berceste Güler

  Kütahya Health Sciences University

  STUDY DIRECTOR

Central Study Contacts

Berceste Güler

CONTACT

+05059359207; berceste.guler@ksbu.edu.tr

Seyma Eken

CONTACT

05518489820; seyma.eken@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Method clinical trial Free gingival graft application has been a routine and successful treatment option since the 1960s. Positioning methods are applied on or apical gingival recession. The aim of this study is to evaluate the effect of two different free gingival graft positioning techniques on the creeping attachment.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: June 1, 2022
• Primary Completion: December 15, 2025
• Study Completion: March 15, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Following acceptance of manuscript
• Access Criteria: Individual participant data can be shared if the principal investigator is contacted

Locations

TU (1)