Connective Tissue Graft HarvestingNCT05494294
Comparison of Different De-epithelialization Techniques of Soft Tissue Grafts.
A study testing Intraorally de-epithelialization and Extraorally de-epithelialization in people with Connective Tissue Graft Harvesting, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Connective Tissue Graft Harvesting
- What is being tested?
- Intraorally de-epithelialization and Extraorally de-epithelialization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jul 2021to 5 Aug 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single tooth recession more than 2mm
- Gingival thickness less than 1mm
Who cannot join
- unstable endodontic conditions or presence of any restoration/abrasion,
- tooth mobility, any surgical history or gingival enlargement in the area,
- smoking
- uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the De-epithelialization Procedure Affect the Epithelial Remnants and Recession Coverage Outcomes?
In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.
- Conditions
- Connective Tissue Graft Harvesting
- Being tested
- Intraorally de-epithelialization, Extraorally de-epithelialization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraorally de-epithelializationProcedure or surgery
In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.
Extraorally de-epithelializationProcedure or surgery
In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral | Active comparator | In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures. Receives: Procedure: Intraorally de-epithelialization |
| Extraoral | Active comparator | In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group. Receives: Procedure: Extraorally de-epithelialization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession reduction
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: 3rd month
Recession reduction
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: 6th month
Recession reduction
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: 12th month
Secondary outcomes (45)
amount of deciduous cells
Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.
Measured: at the day of the surgery.
percentage of deciduous cells
amount of deciduous cells Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.
Measured: at the day of the surgery
Recession Depth (RD)
RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: Baseline.
Recession Depth (RD)
RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: 3rd month
Recession Depth (RD)
RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: 6th month
Recession Depth (RD)
RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: 12th month
Keratinized Tissue Height (KTH)
TH, was measured from gingival margin to the mucogingival junction (MGJ).
Measured: baseline
Keratinized Tissue Height (KTH)
TH, was measured from gingival margin to the mucogingival junction (MGJ).
Measured: 3rd month
Keratinized Tissue Height (KTH)
TH, was measured from gingival margin to the mucogingival junction (MGJ).
Measured: 6th month
Keratinized Tissue Height (KTH)
TH, was measured from gingival margin to the mucogingival junction (MGJ).
Measured: 12th month
Gingival Thickness (GT)
GT, was measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Measured: baseline
Gingival Thickness (GT)
GT, was measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Measured: 3rd month
Gingival Thickness (GT)
GT, was measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Measured: 6th month
Gingival Thickness (GT)
GT, was measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Measured: 12th month
Recession width (RW)
Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.
Measured: baseline
Recession width (RW)
Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.
Measured: 3rd month
Recession width (RW)
Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.
Measured: 6th month
Recession width (RW)
Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.
Measured: 12th month
Probing pocket depth (PD)
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Measured: baseline
Probing pocket depth (PD)
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Measured: 3rd month
Probing pocket depth (PD)
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Measured: 6th month
Probing pocket depth (PD)
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Measured: 12th month
Clinical attachment level (CAL)
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Measured: Baseline
Clinical attachment level (CAL)
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Measured: 3rd month
Clinical attachment level (CAL)
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Measured: 6th month
Clinical attachment level (CAL)
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Measured: 12th month
Keratinized tissue change (KTC)
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
Measured: 3rd month
Keratinized tissue change (KTC)
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
Measured: 6th month
Keratinized tissue change (KTC)
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
Measured: 12th month
Wound healing index (WHI)
Wound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.
Measured: 3rd month
Wound healing index (WHI)
Wound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.
Measured: 6th month
Wound healing index (WHI)
Wound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.
Measured: 12th month
Tissue appearance (TA)
Tissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.
Measured: 3rd month
Tissue appearance (TA)
Tissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.
Measured: 6th month
Tissue appearance (TA)
Tissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.
Measured: 12th month
Dentine hypersensitivity (DH)
Dentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).
Measured: 3rd month
Dentine hypersensitivity (DH)
Dentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).
Measured: 6th month
Dentine hypersensitivity (DH)
Dentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).
Measured: 12th month
Aesthetics (A)
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
Measured: 3rd month
Aesthetics (A)
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
Measured: 6th month
Aesthetics (A)
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
Measured: 12th month
Vestibuler Depth
VD was measured from the gingival margin to the deepest point of to vestibule sulcus.
Measured: baseline
Vestibuler Depth
VD was measured from the gingival margin to the deepest point of to vestibule sulcus.
Measured: 3rd month
Vestibuler Depth
VD was measured from the gingival margin to the deepest point of to vestibule sulcus.
Measured: 6th month
Vestibuler Depth
VD was measured from the gingival margin to the deepest point of to vestibule sulcus.
Measured: 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start4 Jul 2021
- Primary completion30 Jul 2022
- Study completion5 Aug 2022
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 Connective Tissue Graft HarvestingStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gencay Keceli, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494294
- Sponsor's protocol ID
- quality of graft
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Din F, Kabalak MO, Yilmaz BT, Baris E, Avci H, Caglayan F, Keceli HG. Efficacy of different gingival graft de-epithelialization methods: A parallel-group randomized clinical trial. Clin Oral Investig. 2025 May 7;29(6):289. doi: 10.1007/s00784-025-06365-7.
PubMed 40332625
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the De-epithelialization Procedure Affect the Epithelial Remnants and Recession Coverage Outcomes?
- ClinicalTrials.gov ID
- NCT05494294
- Acronym / sponsor ID
- quality of graft
- Conditions
- Connective Tissue Graft Harvesting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 9 Aug 2022 (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 randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.
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 |
|---|---|---|
| Intraoral | Active comparator | Procedure: Intraorally de-epithelializationIn this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures. |
| Extraoral | Active comparator | Procedure: Extraorally de-epithelializationIn this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Single tooth recession more than 2mm
- Gingival thickness less than 1mm
Key exclusion criteria (4 listed)
- unstable endodontic conditions or presence of any restoration/abrasion,
- tooth mobility, any surgical history or gingival enlargement in the area,
- smoking
- uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions
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 |
|---|---|---|
| Intraorally de-epithelializationIn this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures. | Procedure or surgery | Intraoral |
| Extraorally de-epithelializationIn this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group. | Procedure or surgery | Extraoral |
Primary outcome
Recession reduction
Time frame: 3rd month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Recession reduction
Time frame: 6th month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Recession reduction
Time frame: 12th month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
45 secondary outcomes
amount of deciduous cells
Time frame: at the day of the surgery.
percentage of deciduous cells
Time frame: at the day of the surgery
Recession Depth (RD)
Time frame: Baseline.
Recession Depth (RD)
Time frame: 3rd month
Recession Depth (RD)
Time frame: 6th month
Recession Depth (RD)
Time frame: 12th month
Keratinized Tissue Height (KTH)
Time frame: baseline
Keratinized Tissue Height (KTH)
Time frame: 3rd month
Keratinized Tissue Height (KTH)
Time frame: 6th month
Keratinized Tissue Height (KTH)
Time frame: 12th month
Gingival Thickness (GT)
Time frame: baseline
Gingival Thickness (GT)
Time frame: 3rd month
Gingival Thickness (GT)
Time frame: 6th month
Gingival Thickness (GT)
Time frame: 12th month
Recession width (RW)
Time frame: baseline
Recession width (RW)
Time frame: 3rd month
Recession width (RW)
Time frame: 6th month
Recession width (RW)
Time frame: 12th month
Probing pocket depth (PD)
Time frame: baseline
Probing pocket depth (PD)
Time frame: 3rd month
Probing pocket depth (PD)
Time frame: 6th month
Probing pocket depth (PD)
Time frame: 12th month
Clinical attachment level (CAL)
Time frame: Baseline
Clinical attachment level (CAL)
Time frame: 3rd month
Clinical attachment level (CAL)
Time frame: 6th month
Clinical attachment level (CAL)
Time frame: 12th month
Keratinized tissue change (KTC)
Time frame: 3rd month
Keratinized tissue change (KTC)
Time frame: 6th month
Keratinized tissue change (KTC)
Time frame: 12th month
Wound healing index (WHI)
Time frame: 3rd month
Wound healing index (WHI)
Time frame: 6th month
Wound healing index (WHI)
Time frame: 12th month
Tissue appearance (TA)
Time frame: 3rd month
Tissue appearance (TA)
Time frame: 6th month
Tissue appearance (TA)
Time frame: 12th month
Dentine hypersensitivity (DH)
Time frame: 3rd month
Dentine hypersensitivity (DH)
Time frame: 6th month
Dentine hypersensitivity (DH)
Time frame: 12th month
Aesthetics (A)
Time frame: 3rd month
Aesthetics (A)
Time frame: 6th month
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 11 Aug 2022.
- Derived from this study: PubMed 40332625Din F, Kabalak MO, Yilmaz BT, Baris E, Avci H, Caglayan F, Keceli HG. Efficacy of different gingival graft de-epithelialization methods: A parallel-group randomized clinical trial. Clin Oral Investig. 2025 May 7;29(6):289. doi: 10.1007/s00784-025-06365-7.
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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 Intraorally de-epithelialization and Extraorally de-epithelialization in people with Connective Tissue Graft Harvesting, run by Hacettepe 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 2 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 11 Aug 2022. 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?
Recession reduction (time frame: 3rd month). 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?
On the ClinicalTrials.gov record for NCT05494294, 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 11 Aug 2022.