Gingival RecessionNCT04970524
Comparison of Conventional Free Gingival Grafts With Partially De-epithelized Free Gingival Grafts
A study testing Comparison of conventional free gingival graft versus partial free gingival graft in people with Gingival Recession, run by Yonca Naziker at 1 site in Turkey (Türkiye).
Trial summary
In this study, the conventional SDG method applied to increase the adherent gingival band and partial de-epithelialized SDG methods were evaluated in terms of aesthetics and color compatibility of the recipient area with adjacent tissues. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Comparison of conventional free gingival graft versus partial free gingival 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
- 5 May 2019to 4 Feb 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of known systemic disease
- Not using any medication that may affect the periodontal tissues or prolong the bleeding time
- Having not previously operated on the palate area, which is both the receiving area and the donor area.
- The depth of the probing sulcus of all teeth is <3 mm
- Whole mouth plaque index and gingival index scores <1
- The teeth in the operation area are vital
- Absence of caries and / or restoration on the root surfaces of the teeth in the operation area
- Lack of attached gingiva in opposite jaws
Who cannot join
- Pregnant or lactating women,
- Smoking individuals,
- Individuals under the age of 18
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Katip Çelebi University Faculty of dentistry, Periodontology department
Izmir
About this study
Official title: Aesthetic Evaluation of Free Gingival Graft Applied by Partial De-epithelialization and Free Gingival Graft Applied by Conventional Method: a Randomized Controlled Clinical Study
In this study, the conventional SDG method applied to increase the adherent gingival band and partial de-epithelialized SDG methods were evaluated in terms of aesthetics and color compatibility of the recipient area with adjacent tissues.
This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method.Clinical parameters and aesthetic harmony were compared at postoperative 1st, 3rd and 6th months after surgical procedures.Color harmony evaluation was made in 2 different ways, both by photo analysis of a blind researcher using computer software and by visual evaluation of the same blind researcher.
Read the detailed description
The primary aim of this split mouth randomized controlled clinical trial is to compare the partial de-epithelialized free gingival grafting technique with the conventional free gingival grafting technique from an aesthetic point of view. The secondary aim of the study is to evaluate both techniques in terms of periodontal clinical parameters.
This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method. Fifteen patients with attached gingiva width ≤2 mm in the lower jaw bilateral canine and premolar regions were included in the study. De-epithelialized free gingival grafts were applied to the region determined by envelope randomization, and conventional free gingival grafts were applied to the other region. The areas of the patients with insufficient attached gingiva were photographed before the operation, post-op 1st, 3rd, and 6th months, and visual aesthetic evaluations were made with photo analyzes. Clinical parameters such as keratinized gingival width, probing pocket depth, and recession depths were recorded at baseline and at 6 months. Results were represented as mean ± standard deviation and median, and a p value of <0,05 was considered statistically significant.
- Conditions
- Gingival Recession
- Being tested
- Comparison of conventional free gingival graft versus partial free gingival graft
- Keywords
- Partial de-epithelialized free gingival 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.
Comparison of conventional free gingival graft versus partial free gingival graftProcedure or surgery
Conventional free gingival graft was applied to the area of the patient with attached gingival insufficiency determined by randomization.
Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months.
Comparison of conventional free gingival graft versus partial free gingival graftProcedure or surgery
Partially de-epithelialized free gingival graft was applied to the other region of the patient with attached gingival insufficiency determined by randomization.
Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months.
| Study group | Role | What they receive |
|---|---|---|
| control group(conventional free gingival graft) | Experimental | Conventional free gingival grafts are applied to the areas of the patients determined by randomization as suggested by Sullivan and Atkins. Receives: Procedure: Comparison of conventional free gingival graft versus partial free gingival graft |
| test group(Partially de-epithelialized free gingival graft) | Experimental | Partial free gingival graft is applied to the areas of the patients determined by randomization. Unlike the control group, the epithelium on the graft was partially epithelialized. Receives: Procedure: Comparison of conventional free gingival graft versus partial free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
aesthetic evaluation of both surgical methods
Aesthetic evaluation of both surgical methods was done by a blinded researcher by photo analysis. For photo analysis, photographs of the recipient area were taken at the beginning and 6 months after the operation with the help of Adobe Photoshop program and evaluated on these photographs.
Measured: change in post-op 6 months
Secondary outcomes (1)
clinical parameters
In the clinical evaluation of both surgical methods, keratinized tissue width parameters were calculated and compared at baseline and pot-op 6 months.
Measured: change in post-op 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start5 May 2019
- Primary completion15 Sep 2020
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonca Naziker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yonca Naziker, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970524
- Sponsor's protocol ID
- 2020-TDU-DİŞF-0002
- Status last verified
- Sep 2021
- First submitted
- 8 Apr 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Naziker Y, Ertugrul AS. Aesthetic evaluation of free gingival graft applied by partial de-epithelialization and free gingival graft applied by conventional method: a randomized controlled clinical study. Clin Oral Investig. 2023 Jul;27(7):4029-4038. doi: 10.1007/s00784-023-05029-8. Epub 2023 Apr 28.
PubMed 37118334
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Evaluation of Free Gingival Graft Applied by Partial De-epithelialization and Free Gingival Graft Applied by Conventional Method: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04970524
- Acronym / sponsor ID
- 2020-TDU-DİŞF-0002
- Conditions
- Gingival Recession
- Keywords
- Partial de-epithelialized free gingival graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yonca NazikerUniversity, hospital or other
- Study start
- 5 May 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 21 Jul 2021 (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.
In this study, the conventional SDG method applied to increase the adherent gingival band and partial de-epithelialized SDG methods were evaluated in terms of aesthetics and color compatibility of the recipient area with adjacent tissues.
This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method.Clinical parameters and aesthetic harmony were compared at postoperative 1st, 3rd and 6th months after surgical procedures.Color harmony evaluation was made in 2 different ways, both by photo analysis of a blind researcher using computer software and by visual evaluation of the same blind researcher.
Detailed description
The primary aim of this split mouth randomized controlled clinical trial is to compare the partial de-epithelialized free gingival grafting technique with the conventional free gingival grafting technique from an aesthetic point of view. The secondary aim of the study is to evaluate both techniques in terms of periodontal clinical parameters.
This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method. Fifteen patients with attached gingiva width ≤2 mm in the lower jaw bilateral canine and premolar regions were included in the study. De-epithelialized free gingival grafts were applied to the region determined by envelope randomization, and conventional free gingival grafts were applied to the other region. The areas of the patients with insufficient attached gingiva were photographed before the operation, post-op 1st, 3rd, and 6th months, and visual aesthetic evaluations were made with photo analyzes. Clinical parameters such as keratinized gingival width, probing pocket depth, and recession depths were recorded at baseline and at 6 months. Results were represented as mean ± standard deviation and median, and a p value of <0,05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group(conventional free gingival graft) | Experimental | Procedure: Comparison of conventional free gingival graft versus partial free gingival graftConventional free gingival grafts are applied to the areas of the patients determined by randomization as suggested by Sullivan and Atkins. |
| test group(Partially de-epithelialized free gingival graft) | Experimental | Procedure: Comparison of conventional free gingival graft versus partial free gingival graftPartial free gingival graft is applied to the areas of the patients determined by randomization. Unlike the control group, the epithelium on the graft was partially epithelialized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Absence of known systemic disease
- Not using any medication that may affect the periodontal tissues or prolong the bleeding time
- Having not previously operated on the palate area, which is both the receiving area and the donor area.
- The depth of the probing sulcus of all teeth is <3 mm
- Whole mouth plaque index and gingival index scores <1
Key exclusion criteria (3 listed)
- Pregnant or lactating women,
- Smoking individuals,
- Individuals under the age of 18
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 |
|---|---|---|
| Comparison of conventional free gingival graft versus partial free gingival graftConventional free gingival graft was applied to the area of the patient with attached gingival insufficiency determined by randomization. Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months. | Procedure or surgery | control group(conventional free gingival graft) |
| Comparison of conventional free gingival graft versus partial free gingival graftPartially de-epithelialized free gingival graft was applied to the other region of the patient with attached gingival insufficiency determined by randomization. Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months. | Procedure or surgery | test group(Partially de-epithelialized free gingival graft) |
Primary outcome
aesthetic evaluation of both surgical methods
Time frame: change in post-op 6 months
Aesthetic evaluation of both surgical methods was done by a blinded researcher by photo analysis. For photo analysis, photographs of the recipient area were taken at the beginning and 6 months after the operation with the help of Adobe Photoshop program and evaluated on these photographs.
1 secondary outcome
clinical parameters
Time frame: change in post-op 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 17 Sep 2021.
- Derived from this study: PubMed 37118334Naziker Y, Ertugrul AS. Aesthetic evaluation of free gingival graft applied by partial de-epithelialization and free gingival graft applied by conventional method: a randomized controlled clinical study. Clin Oral Investig. 2023 Jul;27(7):4029-4038. doi: 10.1007/s00784-023-05029-8. Epub 2023 Apr 28.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of conventional free gingival graft versus partial free gingival graft in people with Gingival Recession, run by Yonca Naziker 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 8 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 17 Sep 2021. 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?
aesthetic evaluation of both surgical methods (time frame: change in post-op 6 months). 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 NCT04970524, which also lists 1 linked publication.
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 17 Sep 2021.