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Gingival Recession, LocalizedNCT05923294

Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

A study testing Coronally advanced flap with connective tissue graft in people with Gingival Recession, Localized and Sensitivity, Tooth, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Coronally advanced flap with connective tissue graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Aug 2023to 3 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Kutahya Health Sciences University

    Kütahya, 43020

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical Comparison of Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

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.

Being tested
Coronally advanced flap with connective tissue graft
Medical subject headings
Gingival Recession, Dentin Sensitivity, Periodontal Attachment Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronally advanced flap with connective tissue graftProcedure or surgery

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

Study groups in NCT05923294
Study groupRoleWhat they receive
De-epithelialized gingival unit graftExperimentalIn 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.
Receives: Procedure: Coronally advanced flap with connective tissue graft
De-epithelialized free gingival graftExperimentalIn 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.
Receives: Procedure: Coronally advanced flap with connective tissue graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Root coverage percentage

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

    Measured: Postoperative 6th month

  2. Gingival thickness

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

    Measured: Preoperative and postoperative 6th month

Secondary outcomes (7)

  1. Recession width

    Recession width measured at the cemento-enamel junction

    Measured: Preoperative and postoperative 6th month

  2. Probing depth

    Probing depth measured at the mid-buccal of the recession defect

    Measured: Preoperative and postoperative 6th month

  3. Clinical attachment loss

    Clinical attachment loss measured at the mid-buccal of the recession defect

    Measured: Preoperative and postoperative 6th month

  4. Keratinized gingiva width

    Mid-buccal gingival width measured with a periodontal probe

    Measured: Preoperative and postoperative 6th month

  5. Vestibular depth

    The distance from the gingival margin to the greatest concavity of the mucosal fold

    Measured: Preoperative and postoperative 6th month

  6. Pain perception

    Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10

    Measured: Postoperative 1st week

  7. Bleeding related to the procedure

    Bleeding evaluated by a dichotomous index

    Measured: Postoperative 1st week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start10 Aug 2023
  3. Primary completion1 Mar 2024
  4. Study completion3 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923294
Sponsor's protocol ID
0043
Status last verified
Jul 2023
First submitted
20 Jun 2023
Last updated
13 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12636127

  • 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.

    PubMed 26941519

  • 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.

    PubMed 20103476

  • 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.

    PubMed 27454460

  • 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.

    PubMed 31177536

  • 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.

    PubMed 15119887

  • 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.

    PubMed 22390550

  • 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.

    PubMed 32233187

  • Kacar Z, Gurbuz E, Ersoz MM, Couso-Queiruga E, Keceli HG. De-epithelialized gingival unit graft for gingival phenotype modification and root coverage: a randomized controlled trial. Clin Oral Investig. 2026 Jul 13;30(8):318. doi: 10.1007/s00784-026-07001-8.

    PubMed 42437817

Questions about this trial

What is this clinical trial studying?

A study testing Coronally advanced flap with connective tissue graft in people with Gingival Recession, Localized and Sensitivity, Tooth, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Root coverage percentage (time frame: Postoperative 6th month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05923294, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.

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