Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

NCT05923294 | Completed

• 1 other identifier: 0043
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to compare the root coverage rate of the gingival unit-shaped connective tissue graft, obtained by intraoral de-epithelization, with the traditional de-epithelialized free gingival graft in localized recessions of anterior and premolar teeth. In addition, it is aimed to compare the postoperative gingival thickness between the two techniques. The secondary aim is to search the effects of both techniques on periodontal parameters and to evaluate patient-centered outcomes.

Conditions

Gingival Recession, Localized; Sensitivity, Tooth; Attachment Loss, Periodontal

Outcome Measures

Primary Outcomes (2)

• Root coverage percentage

  The comparison of the postoperative recession depth to the initial recession depth

  Postoperative 6th month

• Gingival thickness

  Gingival thickness in the mid-buccal of the recession defect measured with an endodontic spreader and digital recordings

  Preoperative and postoperative 6th month

Secondary Outcomes (7)

• Recession width

  Preoperative and postoperative 6th month

• Probing depth

  Preoperative and postoperative 6th month

• Clinical attachment loss

  Preoperative and postoperative 6th month

• Keratinized gingiva width

  Preoperative and postoperative 6th month

• Vestibular depth

  Preoperative and postoperative 6th month

Study Arms (2)

De-epithelialized gingival unit graft

EXPERIMENTAL

In this split-mouth randomized controlled trial, the coin toss method will determine test and control groups. In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area. To obtain the connective tissue graft, the gingival unit graft will be de-epithelialized in the test group.

Procedure: Coronally advanced flap with connective tissue graft

De-epithelialized free gingival graft

EXPERIMENTAL

In this split-mouth randomized controlled trial, the coin toss method will determine test and control groups. In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area. To obtain the connective tissue graft, the traditional free gingival graft will be de-epithelialized in the control group.

Procedure: Coronally advanced flap with connective tissue graft

Interventions

Coronally advanced flap with connective tissue graft PROCEDURE

In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area.

De-epithelialized free gingival graft; De-epithelialized gingival unit graft

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists physical status class 1 and 2 patients,healthy patients
• Nonsmokers
• Periodontally healthy patients
• Localized gingival recessions (Miller I, II, and Cairo I recessions with a depth of recession of at least 2 mm) in anterior and premolar teeth

You may not qualify if:

• Medically compromised patients, especially uncontrolled diabetes
• Pregnancy, lactation, or suspicion of pregnancy,
• Poor oral hygiene
• Recessions associated with caries or restoration

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Location

Related Publications (8)

• Kassab MM, Cohen RE. The etiology and prevalence of gingival recession. J Am Dent Assoc. 2003 Feb;134(2):220-5. doi: 10.14219/jada.archive.2003.0137.

  PMID: 12636127 BACKGROUND

• Mythri S, Arunkumar SM, Hegde S, Rajesh SK, Munaz M, Ashwin D. Etiology and occurrence of gingival recession - An epidemiological study. J Indian Soc Periodontol. 2015 Nov-Dec;19(6):671-5. doi: 10.4103/0972-124X.156881.

  PMID: 26941519 BACKGROUND

• Kassab MM, Badawi H, Dentino AR. Treatment of gingival recession. Dent Clin North Am. 2010 Jan;54(1):129-40. doi: 10.1016/j.cden.2009.08.009.

  PMID: 20103476 BACKGROUND

• Cairo F, Pagliaro U, Buti J, Baccini M, Graziani F, Tonelli P, Pagavino G, Tonetti MS. Root coverage procedures improve patient aesthetics. A systematic review and Bayesian network meta-analysis. J Clin Periodontol. 2016 Nov;43(11):965-975. doi: 10.1111/jcpe.12603. Epub 2016 Sep 16.

  PMID: 27454460 BACKGROUND

• Zucchelli G, Tavelli L, Barootchi S, Stefanini M, Rasperini G, Valles C, Nart J, Wang HL. The influence of tooth location on the outcomes of multiple adjacent gingival recessions treated with coronally advanced flap: A multicenter re-analysis study. J Periodontol. 2019 Nov;90(11):1244-1251. doi: 10.1002/JPER.18-0732. Epub 2019 Jul 1.

  PMID: 31177536 BACKGROUND

• Allen AL. Use of the gingival unit transfer in soft tissue grafting: report of three cases. Int J Periodontics Restorative Dent. 2004 Apr;24(2):165-75.

  PMID: 15119887 BACKGROUND

• Kuru B, Yildirim S. Treatment of localized gingival recessions using gingival unit grafts: a randomized controlled clinical trial. J Periodontol. 2013 Jan;84(1):41-50. doi: 10.1902/jop.2012.110685. Epub 2012 Mar 5.

  PMID: 22390550 BACKGROUND

• Sriwil M, Fakher MAA, Hasan K, Kasem T, Shwaiki T, Wassouf G. Comparison of Free Gingival Graft and Gingival Unit Graft for Treatment of Gingival Recession: A Randomized Controlled Trial. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e103-e110. doi: 10.11607/prd.4180.

  PMID: 32233187 BACKGROUND

MeSH Terms

Conditions

Gingival Recession; Dentin Sensitivity; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

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

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 20, 2023
• First Posted: June 28, 2023
• Study Start: August 10, 2023
• Primary Completion: March 1, 2024
• Study Completion: July 3, 2024
• Last Updated: August 13, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)