Gingival PhenotypeNCT04690140
Can Modified Coronally Advanced Tunnel be an Alternative in Gingival Phenotype Modification?
A study testing Epithelialized free gingival graft and Modified coronally advanced tunnel technique in people with Gingival Phenotype, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In the randomized comparative controlled trial, 50 patients with insufficient keratinized tissue at the anterior mandible were treated with either Modified coronally advanced tunnel or epithelialized free gingival graft. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Phenotype
- What is being tested?
- Epithelialized free gingival graft and Modified coronally advanced tunnel technique
- 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
- 5 May 2019to 10 Jul 2020
- 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
- presence of at least two anterior mandibular teeth with keratinized tissue height≤1 mm with gingival thickness ≤1mm
- presence of at least two recession type-1 recessions at mandibular anterior teeth and at least one recession with recession depth ≥2 mm,
- aged between 18-60.
Who cannot join
- unstable endodontic conditions or presence of any restoration/abrasion,
- tooth mobility, any surgical history or gingival enlargement in the area,
- smoking or alcohol use,
- 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: Can Modified Coronally Advanced Tunnel be an Alternative to Epithelialized Free Gingival Graft Technique in Gingival Phenotype Modification? A Comparative Controlled Randomized Clinical Trial
In the randomized comparative controlled trial, 50 patients with insufficient keratinized tissue at the anterior mandible were treated with either Modified coronally advanced tunnel or epithelialized free gingival graft. At baseline, 6th week, 6th month, 12th-month visits; keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were 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
- Gingival Phenotype
- Being tested
- Epithelialized free gingival graft, Modified coronally advanced tunnel technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epithelialized free gingival graftProcedure or surgery
The Epithelialized free gingival graft placed on the prepared bed.
Modified coronally advanced tunnel techniqueProcedure or surgery
Connective tissue graft placed under the prepared tunnel
| Study group | Role | What they receive |
|---|---|---|
| modified coronally advanced tunnel technique | Active comparator | Initial sulcular incisions and flap separation were then carried out with tunnel knives. Dissection was extended at least 8 mm apically to the mucogingival junction and the muscle attachments were removed with curettes so that the flap could be moved in a coronal direction without tension. Interdental papillae were undermined to prepare the bed for connective tissue graft placement. Connective tissue graft was then inserted under the tunnel at the sites of recession and retracted laterally by sutures towards each end of the tunnel. After connective tissue graft positioning, the flap was gently stretched coronally to obtain passive flap closure. The exposed connective tissue was covered by connecting the adjacent flap margins with additional sutures. Receives: Procedure: Modified coronally advanced tunnel technique |
| epithelialized free gingival graft | Active comparator | A partial-thickness flap was elevated (blade #15c) with horizontal incisions at the cemento-enamel junction level of the adjacent teeth. Then, two vertical incisions extending to the apical were made from two ends of the horizontal incision. The epithelium in the framed region was removed with a scalpel and the underlying connective tissue was exposed. To achieve the best vascularization from the recipient site, bed preparation was completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region. Receives: Procedure: Epithelialized free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Thickness
GT, 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, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Measured: 6th week
Gingival Thickness (GT)
GT, measured at the mid-point 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, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Measured: 12th month
Keratinized Tissue Height (KTH)
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Measured: Baseline
Keratinized Tissue Height (KTH)
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Measured: 6th week
Keratinized Tissue Height (KTH)
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Measured: 6th month
Keratinized Tissue Height (KTH)
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Measured: 12th month.
Secondary outcomes (25)
Recession Depth (RD)
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: Baseline
Recession Depth (RD)
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: 6th week
Recession Depth (RD)
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Measured: 6th month
Recession Depth (RD)
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
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: 6th week
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: 6th week
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: 6th week
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: Baseline
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 week
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: 6th week
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 week
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 week
Patient expectations (PE)
Patient expectations (PE) were evaluated by requesting from the patients to rate their treatment results at T2, as satisfactory or not, in terms of appearance, experience and obtained root coverage.
Measured: 6th week
Aesthetics (A)
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start5 May 2019
- Primary completion5 Jun 2020
- Study completion10 Jul 2020
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 PhenotypeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, 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
- NCT04690140
- Sponsor's protocol ID
- Phenotype Modification
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yilmaz BT, Comerdov E, Kutuk C, Nart J, Keceli HG. Modified coronally advanced tunnel versus epithelialized free gingival graft technique in gingival phenotype modification: a comparative randomized controlled clinical trial. Clin Oral Investig. 2022 Oct;26(10):6283-6293. doi: 10.1007/s00784-022-04580-0. Epub 2022 Jun 16.
PubMed 35708779
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Modified Coronally Advanced Tunnel be an Alternative to Epithelialized Free Gingival Graft Technique in Gingival Phenotype Modification? A Comparative Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04690140
- Acronym / sponsor ID
- Phenotype Modification
- Conditions
- Gingival Phenotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 May 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 30 Dec 2020 (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 the randomized comparative controlled trial, 50 patients with insufficient keratinized tissue at the anterior mandible were treated with either Modified coronally advanced tunnel or epithelialized free gingival graft. At baseline, 6th week, 6th month, 12th-month visits; keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified coronally advanced tunnel technique | Active comparator | Procedure: Modified coronally advanced tunnel techniqueInitial sulcular incisions and flap separation were then carried out with tunnel knives. Dissection was extended at least 8 mm apically to the mucogingival junction and the muscle attachments were removed with curettes so that the flap could be moved in a coronal direction without tension. Interdental papillae were undermined to prepare the bed for connective tissue graft placement. Connective tissue graft was then inserted under the tunnel at the sites of recession and retracted laterally by sutures towards each end of the tunnel. After connective tissue graft positioning, the flap was gently stretched coronally to obtain passive flap closure. The exposed connective tissue was covered by connecting the adjacent flap margins with additional sutures. |
| epithelialized free gingival graft | Active comparator | Procedure: Epithelialized free gingival graftA partial-thickness flap was elevated (blade #15c) with horizontal incisions at the cemento-enamel junction level of the adjacent teeth. Then, two vertical incisions extending to the apical were made from two ends of the horizontal incision. The epithelium in the framed region was removed with a scalpel and the underlying connective tissue was exposed. To achieve the best vascularization from the recipient site, bed preparation was completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- presence of at least two anterior mandibular teeth with keratinized tissue height≤1 mm with gingival thickness ≤1mm
- presence of at least two recession type-1 recessions at mandibular anterior teeth and at least one recession with recession depth ≥2 mm,
- aged between 18-60.
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 or alcohol use,
- 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 |
|---|---|---|
| Epithelialized free gingival graftThe Epithelialized free gingival graft placed on the prepared bed. | Procedure or surgery | epithelialized free gingival graft |
| Modified coronally advanced tunnel techniqueConnective tissue graft placed under the prepared tunnel | Procedure or surgery | modified coronally advanced tunnel technique |
Primary outcome
Gingival Thickness
Time frame: Baseline
GT, 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).
Gingival Thickness (GT)
Time frame: 6th week
GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Gingival Thickness (GT)
Time frame: 6th month
GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Gingival Thickness (GT)
Time frame: 12th month
GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Keratinized Tissue Height (KTH)
Time frame: Baseline
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Keratinized Tissue Height (KTH)
Time frame: 6th week
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Keratinized Tissue Height (KTH)
Time frame: 6th month
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Keratinized Tissue Height (KTH)
Time frame: 12th month.
KTH, measured from gingival margin to the mucogingival junction (MGJ).
25 secondary outcomes
Recession Depth (RD)
Time frame: Baseline
Recession Depth (RD)
Time frame: 6th week
Recession Depth (RD)
Time frame: 6th month
Recession Depth (RD)
Time frame: 12th month.
Recession width (RW)
Time frame: Baseline
Recession width (RW)
Time frame: 6th week
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: 6th week
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: 6th week
Clinical attachment level (CAL)
Time frame: 6th month
Clinical attachment level (CAL)
Time frame: 12th month
Keratinized tissue change (KTC)
Time frame: Baseline
Keratinized tissue change (KTC)
Time frame: 6th week
Keratinized tissue change (KTC)
Time frame: 6th month
Keratinized tissue change (KTC)
Time frame: 12th month
Wound healing index (WHI)
Time frame: 6th week
Tissue appearance (TA)
Time frame: 6th week
Dentine hypersensitivity (DH)
Time frame: 6th week
Patient expectations (PE)
Time frame: 6th week
Aesthetics (A)
Time frame: 6th week
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 6 Mar 2024.
- Derived from this study: PubMed 35708779Yilmaz BT, Comerdov E, Kutuk C, Nart J, Keceli HG. Modified coronally advanced tunnel versus epithelialized free gingival graft technique in gingival phenotype modification: a comparative randomized controlled clinical trial. Clin Oral Investig. 2022 Oct;26(10):6283-6293. doi: 10.1007/s00784-022-04580-0. Epub 2022 Jun 16.
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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 Epithelialized free gingival graft and Modified coronally advanced tunnel technique in people with Gingival Phenotype, 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 3 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 6 Mar 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?
Gingival Thickness (time frame: Baseline). The study lists 8 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 NCT04690140, 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 6 Mar 2024.