Gingival RecessionNCT04181892
Effect of Connective Tissue Graft Position
A study testing Coronally advanced flap + connective tissue graft in people with Gingival Recession, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study was to compare the root coverage and aesthetic results of CAF+ CTG positioned apical to the CEJ (CAF+CTG-ACEJ) with CAF+CTG positioned on the CEJ (CAF+CTG-CEJ) for treating isolated gingival recession defects. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Coronally advanced flap + connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Sep 2019
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19 years of age,
- Periodontally and systemically healthy,
- FMPS and FMBS <15%,
- Presence of Miller Class I/II GR defect (≥3 mm in depth) at the buccal aspect of incisors and canines,
- Presence of identifiable CEJ (step ≤1 mm at CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ, was accepted),
- No previous periodontal surgery.
Who cannot join
- Smoking,
- Contraindications for surgery,
- Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Dentistry
Adana
About this study
Official title: The Effects of Connective Tissue Graft Position on Clinical and Aesthetical Outcomes of Gingival Recession Treatment. A Controlled Randomized Clinical Trial
Aim: The aim of this study was to compare the root coverage and aesthetic results of CAF+ CTG positioned apical to the CEJ (CAF+CTG-ACEJ) with CAF+CTG positioned on the CEJ (CAF+CTG-CEJ) for treating isolated gingival recession defects.
Methods: Thirthy-eight patients with Miller class I and II gingival recessions were enrolled. 19 patients were randomly assigned to the CAF+CTG-ACEJ group or CAF+CTG-CEJ group. Clinical and aesthetical evaluations were made at 6 months.
- Conditions
- Gingival Recession
- Being tested
- Coronally advanced flap + connective tissue graft
- Keywords
- connective tissue graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally advanced flap + connective tissue graftProcedure or surgery
connective tissue graft covered by a coronally advanced flap with connective tissue graft apical of the cementoenamel junction level
| Study group | Role | What they receive |
|---|---|---|
| CAF+ CTG positioned apical to the CEJ | Experimental | Connective tissue graft covered by a coronally advanced flap which CTG apical of the CEJ level Receives: Procedure: Coronally advanced flap + connective tissue graft |
| CAF+CTG positioned on the CEJ | Other | Connective tissue graft covered by a coronally advanced flap which CTG on the CEJ level Receives: Procedure: Coronally advanced flap + connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Recession depth in millimeters
measured from the cemento-enamel junction to the gingival margin
Measured: 6 months
keratinized tissue height in millimeters
measured from the mucogingival junction to the gingival margin
Measured: 6 months
aesthetic evaluation assesed by visual analog scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Mar 2018
- Primary completion1 Feb 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozcan, Cukurova University
- Investigators
- Onur Ucak Turer, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181892
- Sponsor's protocol ID
- CukurovaU-PER-I
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Connective Tissue Graft Position on Clinical and Aesthetical Outcomes of Gingival Recession Treatment. A Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04181892
- Acronym / sponsor ID
- CukurovaU-PER-I
- Conditions
- Gingival Recession
- Keywords
- connective tissue graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: The aim of this study was to compare the root coverage and aesthetic results of CAF+ CTG positioned apical to the CEJ (CAF+CTG-ACEJ) with CAF+CTG positioned on the CEJ (CAF+CTG-CEJ) for treating isolated gingival recession defects.
Methods: Thirthy-eight patients with Miller class I and II gingival recessions were enrolled. 19 patients were randomly assigned to the CAF+CTG-ACEJ group or CAF+CTG-CEJ group. Clinical and aesthetical evaluations were made at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF+ CTG positioned apical to the CEJ | Experimental | Procedure: Coronally advanced flap + connective tissue graftConnective tissue graft covered by a coronally advanced flap which CTG apical of the CEJ level |
| CAF+CTG positioned on the CEJ | Other | Procedure: Coronally advanced flap + connective tissue graftConnective tissue graft covered by a coronally advanced flap which CTG on the CEJ level |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 19 years of age,
Key exclusion criteria (3 listed)
- Smoking,
- Contraindications for surgery,
- Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronally advanced flap + connective tissue graftconnective tissue graft covered by a coronally advanced flap with connective tissue graft apical of the cementoenamel junction level | Procedure or surgery | CAF+ CTG positioned apical to the CEJ, CAF+CTG positioned on the CEJ |
Primary outcome
Gingival Recession depth in millimeters
Time frame: 6 months
measured from the cemento-enamel junction to the gingival margin
keratinized tissue height in millimeters
Time frame: 6 months
measured from the mucogingival junction to the gingival margin
aesthetic evaluation assesed by visual analog scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Gingival Recession
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Recruiting
Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onur Ucak Turer, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally advanced flap + connective tissue graft in people with Gingival Recession, run by Cukurova 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 6 inclusion and 3 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 2 Dec 2019. 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?
Gingival Recession depth in millimeters (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2019.