Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

NCT ID: NCT05923294

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2024-07-03

Brief Summary

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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.

Detailed Description

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Conditions

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Gingival Recession, Localized Sensitivity, Tooth Attachment Loss, Periodontal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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De-epithelialized gingival unit graft

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.

Group Type EXPERIMENTAL

Coronally advanced flap with connective tissue graft

Intervention Type PROCEDURE

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

De-epithelialized free gingival graft

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.

Group Type EXPERIMENTAL

Coronally advanced flap with connective tissue graft

Intervention Type PROCEDURE

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

Interventions

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Coronally advanced flap with connective tissue graft

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. American Society of Anesthesiologists physical status class 1 and 2 patients,healthy patients
2. Nonsmokers
3. Periodontally healthy patients
4. 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

Exclusion Criteria

1. Medically compromised patients, especially uncontrolled diabetes
2. Pregnancy, lactation, or suspicion of pregnancy,
3. Poor oral hygiene
4. Recessions associated with caries or restoration
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Ezgi Gürbüz

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kutahya Health Sciences University

Kütahya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 12636127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26941519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20103476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27454460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31177536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15119887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22390550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32233187 (View on PubMed)

Other Identifiers

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0043

Identifier Type: -

Identifier Source: org_study_id

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