Gingival RecessionNCT06272006
The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach
A study testing Coronally Positioned Flap with Connective Tissue Graft and Modified Coronally Advanced Tunnel with Connective Tissue Graft in people with Gingival Recession, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession. The main questions it aims to answer are: Which treatment method, Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft, is more effective in… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Coronally Positioned Flap with Connective Tissue Graft and Modified Coronally Advanced Tunnel with Connective Tissue Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2024to 5 Mar 2025
- 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
- Participants aged 18 to 60 years.
- Individuals with the gingival recession of Miller Class I, II, or III in at least one tooth in the anterior mandibular or maxillary region.
- Participants must have at least 1 mm of keratinized tissue width around the affected tooth/tooth and be in good general health.
- Ability to provide informed consent for participation in the study.
Who cannot join
- Individuals with uncontrolled systemic diseases that could impact periodontal healing (e.g., diabetes mellitus, cardiovascular diseases).
- Current smokers or those who have quit smoking less than 6 months before the study.
- Women who are pregnant or breastfeeding.
- Participants who have received periodontal or gingival recession treatment in the study area within the last year.
- Presence of acute periodontal or dental infections requiring immediate treatment, or extensive caries affecting the study teeth.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession. The main questions it aims to answer are:
Which treatment method, Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft, is more effective in treating gum recession? How does the Anatomical Recession Rate, a new measurement technique, help in evaluating the success of these treatments?
The patients will be treated with coronally advanced flap or modified coronally advanced tunnel + connective tissue graft to see which method is more effective in reducing gum recession, as measured by using anatomical recession rate.
Read the detailed description
The aim of this study is to evaluate the success of gingival recession treatment methods of coronally advanced flap (CAF) and modified coronally advanced tunnel (MCAT) by using the anatomical ratio rate (ARR). In the parallel-group two-arm randomized clinical study, 40 randomly assigned participants into CAF and MCAT groups will be enrolled. The assessor and investigator will be masked to the interventions that will be applied.
Intervention (CAF): After local anesthesia, the recipient area will be prepared by making a vertical incision from the mesial and/or distal of the last tooth areas where the recession ends, and by applying split-full-split-thickness incisions along with sulcular and subpapillary incisions, thus releasing the flap to facilitate coronal movement. Afterwards, the anatomical papillae will be deepithelised and the recipient area preparation will be completed by applying SRP to the root surfaces. Then, CTG will be harvested from the palatal region by measuring the dimensions of the recession defect. The obtained CTG will be placed on the root surface and sutured to the anatomical papillae with the resorbable sutures. Then, the flap will be sutured to the anatomical papillae with suspended sutures, completely covering the connective tissue graft. Finally, vertical incisions will be sutured to easily coronally position the flap Intervention (MCAT): A split-thickness envelope flap will be created by performing supraperiosteal undermining with tunnel blades and elevators along the facial surface of the papilla. Undermining will be extended to the apical part of the mucogingival line. In order to coronally position the flap, the papillary region will be elevated in full thickness and a supraperiosteal envelope recipient bed will be created. Then, CTG will be obtained according to the size of the recession defect from the palatal region and placed under the tunnel with guide sutures and positioned on the root surfaces, and then the envelope flap will be sutured by pulling it coronally with double cross sutures to completely cover the CTG.
Primary Outcome Measure:
Anatomical Recession Rate (ARR): The primary outcome measure is the Anatomical Recession Rate (ARR), which quantifies the effectiveness of the Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) and the Modified Coronally Advanced Tunnel (MCAT) with CTG in covering exposed root surfaces. ARR is calculated by measuring the linear distance between the gingival margin and the cementoenamel junction before and after treatment, with improvements in ARR indicating successful root coverage [Time Frame: 12 months post-treatment].
Secondary Outcome Measures:
Clinical Attachment Level (CAL): This secondary outcome measures the change in the clinical attachment level, indicating the health of the periodontal tissue and its attachment to the tooth root. CAL is a critical parameter for assessing periodontal health and the success of root coverage procedures [Time Frame: Baseline, 3, 6, and 12 months post-treatment].
Gingival Thickness (GT): This outcome assesses the change in gingival thickness, measured in millimeters, post-treatment. Increased gingival thickness is associated with better prognosis and sustainability of the root coverage [Time Frame: Baseline and 12 months post-treatment].
Keratinized Tissue Thickness (KTT): This secondary outcome measures the change in keratinized tissue thickness, indicating the improvement in the quantity of keratinized gum tissue post-treatment. An increase in KTT is considered beneficial for periodontal health and stability, as thicker keratinized tissue can better protect underlying bone and tooth roots from bacterial invasion and mechanical trauma. The thickness will be measured using a periodontal probe or ultrasound device, providing a quantitative assessment of the treatment's effectiveness in enhancing gum tissue resilience [Time Frame: Baseline, 3, 6, and 12 months post-treatment].
Wound healing index (WHI): This outcome will be recorded after surgery using the following criteria: score 1 = uneventful healing with no edema, erythema, suppuration, discomfort, or dehiscence; score 2 = uneventful healing with slight edema, erythema, discomfort, or dehiscence, but no suppuration; and score 3 = poor healing with significant edema, erythema, discomfort, flap dehiscence, or suppuration. [Time Frame: 2 weeks post-treatment].
Tissue appearance: This parameter will be scored according to the consistency, contour, color match, keloid formation degree, and contiguity of the treated sites at T3. Consistency will be rated as firm (1p) or spongy (0p); contour as the presence (2p) or absence (0p) of knife-edged and scalloped GM; color match as excellent (3p), good (2p), adequate (1p), or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); and contiguity as the presence (1p) or absence (0p) of each perceptible incision mark [Time Frame: 6 and 12 months post-treatment].
Aesthetic evaluation: Aesthetics will be evaluated according to the five variables of root coverage esthetic score (RES): GM position, marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). GM position was scored as 0, 3, or 6, whereas each other variable was scored as 0 or 1 [Time Frame: 6 and 12 months post-treatment].
Dentin hypersensitivity: Hypersensitivity will be recorded using a visual analog scale (VAS) (0 = no pain, 10 = extreme pain) after 3-s air blast applied to the cervical portions of the included sites from a triple syringe [Time Frame: Baseline, 6, and 12 months post-treatment].
Eligibility criteria Minimum Age: 18 Years Maximum Age: 60 Years Sex: All Gender Based: No Accepts Healthy Volunteers: Yes
Inclusion Criteria:
Participants aged 18 to 60 years. Individuals with the gingival recession of Miller Class I, II, or III in at least one tooth in the anterior mandibular or maxillary region.
Participants must have at least 1 mm of keratinized tissue width around the affected tooth/tooth and be in good general health.
Ability to provide informed consent for participation in the study.
Exclusion Criteria:
Individuals with uncontrolled systemic diseases that could impact periodontal healing (e.g., diabetes mellitus, cardiovascular diseases).
Current smokers or those who have quit smoking less than 6 months before the study.
Women who are pregnant or breastfeeding. Participants who have received periodontal or gingival recession treatment in the study area within the last year.
Presence of acute periodontal or dental infections requiring immediate treatment, or extensive caries affecting the study teeth.
- Conditions
- Gingival Recession
- Being tested
- Coronally Positioned Flap with Connective Tissue Graft, Modified Coronally Advanced Tunnel with 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 Positioned Flap with Connective Tissue GraftProcedure or surgery
his intervention involves surgically repositioning the gum tissue over the exposed tooth root and adding a connective tissue graft. The graft is obtained from the patient's palate and placed in the area of gingival recession to promote tissue regeneration and enhance root coverage. The procedure aims to reduce gingival recession and improve periodontal health.
Modified Coronally Advanced Tunnel with Connective Tissue GraftProcedure or surgery
This intervention utilizes a minimally invasive technique to create a tunnel beneath the gum tissue, through which a connective tissue graft is placed. The graft, sourced from the patient's palate, is used to encourage the growth of new gum tissue over the exposed root. This method is designed to minimize trauma and promote faster recovery, aiming to improve root coverage and periodontal outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) | Experimental | Participants in this arm will receive a Coronally Positioned Flap (CPF) surgery combined with a Connective Tissue Graft (CTG). The CPF technique involves surgically repositioning the gum tissue to cover exposed root surfaces, while the CTG procedure involves transplanting connective tissue to the area of gingival recession to encourage regeneration and coverage of exposed roots. This arm aims to evaluate the effectiveness of CPF with CTG in improving gingival recession and periodontal health. Receives: Procedure: Coronally Positioned Flap with Connective Tissue Graft |
| Modified Coronally Advanced Tunnel (MCAT) with Connective Tissue Graft (CTG) | Experimental | This arm involves participants receiving the Modified Coronally Advanced Tunnel (MCAT) procedure along with a Connective Tissue Graft (CTG). The MCAT technique is a less invasive approach that creates a tunnel under the gum through which the connective tissue graft is placed without making significant incisions. This method aims to treat gingival recession by encouraging gum regeneration over the exposed roots, with the goal of improving periodontal outcomes and reducing recession. Receives: Procedure: Modified Coronally Advanced Tunnel with Connective Tissue Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical Recession Rate (ARR)
The primary outcome measure is the Anatomical Recession Rate (ARR), which quantifies the effectiveness of the Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) and the Modified Coronally Advanced Tunnel (MCAT) with CTG in covering exposed root surfaces. ARR is calculated by measuring the linear distance between the gingival margin and the cementoenamel junction before and after treatment, with improvements in ARR indicating successful root coverage.
Measured: 12 months post-treatment
Secondary outcomes (7)
Clinical Attachment Level (CAL)
This secondary outcome measures the change in the clinical attachment level, indicating the health of the periodontal tissue and its attachment to the tooth root. CAL is a critical parameter for assessing periodontal health and the success of root coverage procedures.
Measured: Baseline, 3, 6, and 12 months post-treatment
Gingival Thickness (GT)
This outcome assesses the change in gingival thickness, measured in millimeters, post-treatment. Increased gingival thickness is associated with better prognosis and sustainability of the root coverage.
Measured: Baseline and 12 months post-treatment
Keratinized Tissue Thickness (KTT)
This secondary outcome measures the change in keratinized tissue thickness, indicating the improvement in the quantity of keratinized gum tissue post-treatment. An increase in KTT is considered beneficial for periodontal health and stability, as thicker keratinized tissue can better protect underlying bone and tooth roots from bacterial invasion and mechanical trauma. The thickness will be measured using a periodontal probe or ultrasound device, providing a quantitative assessment of the treatment's effectiveness in enhancing gum tissue resilience.
Measured: Baseline, 3, 6, and 12 months post-treatment
Wound healing index (WHI)
This outcome measures the healing by using the following criteria: score 1 = uneventful healing with no edema, erythema, suppuration, discomfort, or dehiscence; score 2 = uneventful healing with slight edema, erythema, discomfort, or dehiscence, but no suppuration; and score 3 = poor healing with significant edema, erythema, discomfort, flap dehiscence, or suppuration
Measured: 2 weeks post-treatment
Tissue appearance
This parameter will be scored according to the consistency, contour, color match, keloid formation degree, and contiguity of the treated sites at T3. Consistency will be rated as firm (1p) or spongy (0p); contour as the presence (2p) or absence (0p) of knife-edged and scalloped GM; color match as excellent (3p), good (2p), adequate (1p), or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); and contiguity as the presence (1p) or absence (0p) of each perceptible incision mark
Measured: 6 and 12 months post-treatment
Aesthetic evaluation
Aesthetics will be evaluated according to the five variables of root coverage esthetic score (RES): GM position, marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). GM position was scored as 0, 3, or 6, whereas each other variable was scored as 0 or 1
Measured: 6 and 12 months post-treatment
Dentin hypersensitivity
Hypersensitivity will be recorded using a visual analog scale (VAS) (0 = no pain, 10 = extreme pain) after 3-s air blast applied to the cervical portions of the included sites from a triple syringe
Measured: Baseline, 6, and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start24 Feb 2024
- Primary completion4 Feb 2025
- Study completion5 Mar 2025
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
- Model description
- This randomized controlled trial compares two gingival recession treatments: Coronally Advanced Flap (CAF) with Connective Tissue Graft (CTG) versus Modified Coronally Advanced Tunnel (MCAT) with CTG. Participants are randomized 1:1 to either intervention. Outcomes assessors are blinded to allocation, ensuring unbiased evaluation of the primary outcome, Anatomical Recession Rate (ARR), and secondary clinical outcomes over a 12-month follow-up.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gencay Keceli, Hacettepe University
- Investigators
- Gencay Keceli, PHD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272006
- Sponsor's protocol ID
- Anatomical recession
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach
- ClinicalTrials.gov ID
- NCT06272006
- Acronym / sponsor ID
- Anatomical recession
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 22 Feb 2024 (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.
The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession. The main questions it aims to answer are:
Which treatment method, Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft, is more effective in treating gum recession? How does the Anatomical Recession Rate, a new measurement technique, help in evaluating the success of these treatments?
The patients will be treated with coronally advanced flap or modified coronally advanced tunnel + connective tissue graft to see which method is more effective in reducing gum recession, as measured by using anatomical recession rate.
Detailed description
The aim of this study is to evaluate the success of gingival recession treatment methods of coronally advanced flap (CAF) and modified coronally advanced tunnel (MCAT) by using the anatomical ratio rate (ARR). In the parallel-group two-arm randomized clinical study, 40 randomly assigned participants into CAF and MCAT groups will be enrolled. The assessor and investigator will be masked to the interventions that will be applied.
Intervention (CAF): After local anesthesia, the recipient area will be prepared by making a vertical incision from the mesial and/or distal of the last tooth areas where the recession ends, and by applying split-full-split-thickness incisions along with sulcular and subpapillary incisions, thus releasing the flap to facilitate coronal movement. Afterwards, the anatomical papillae will be deepithelised and the recipient area preparation will be completed by applying SRP to the root surfaces. Then, CTG will be harvested from the palatal region by measuring the dimensions of the recession defect. The obtained CTG will be placed on the root surface and sutured to the anatomical papillae with the resorbable sutures. Then, the flap will be sutured to the anatomical papillae with suspended sutures, completely covering the connective tissue graft. Finally, vertical incisions will be sutured to easily coronally position the flap Intervention (MCAT): A split-thickness envelope flap will be created by performing supraperiosteal undermining with tunnel blades and elevators along the facial surface of the papilla. Undermining will be extended to the apical part of the mucogingival line. In order to coronally position the flap, the papillary region will be elevated in full thickness and a supraperiosteal envelope recipient bed will be created. Then, CTG will be obtained according to the size of the recession defect from the palatal region and placed under the tunnel with guide sutures and positioned on the root surfaces, and then the envelope flap will be sutured by pulling it coronally with double cross sutures to completely cover the CTG.
Primary Outcome Measure:
Anatomical Recession Rate (ARR): The primary outcome measure is the Anatomical Recession Rate (ARR), which quantifies the effectiveness of the Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) and the Modified Coronally Advanced Tunnel (MCAT) with CTG in covering exposed root surfaces. ARR is calculated by measuring the linear distance between the gingival margin and the cementoenamel junction before and after treatment, with improvements in ARR indicating successful root coverage [Time Frame: 12 months post-treatment].
Secondary Outcome Measures:
Clinical Attachment Level (CAL): This secondary outcome measures the change in the clinical attachment level, indicating the health of the periodontal tissue and its attachment to the tooth root. CAL is a critical parameter for assessing periodontal health and the success of root coverage procedures [Time Frame: Baseline, 3, 6, and 12 months post-treatment].
Gingival Thickness (GT): This outcome assesses the change in gingival thickness, measured in millimeters, post-treatment. Increased gingival thickness is associated with better prognosis and sustainability of the root coverage [Time Frame: Baseline and 12 months post-treatment].
Keratinized Tissue Thickness (KTT): This secondary outcome measures the change in keratinized tissue thickness, indicating the improvement in the quantity of keratinized gum tissue post-treatment. An increase in KTT is considered beneficial for periodontal health and stability, as thicker keratinized tissue can better protect underlying bone and tooth roots from bacterial invasion and mechanical trauma. The thickness will be measured using a periodontal probe or ultrasound device, providing a quantitative assessment of the treatment's effectiveness in enhancing gum tissue resilience [Time Frame: Baseline, 3, 6, and 12 months post-treatment].
Wound healing index (WHI): This outcome will be recorded after surgery using the following criteria: score 1 = uneventful healing with no edema, erythema, suppuration, discomfort, or dehiscence; score 2 = uneventful healing with slight edema, erythema, discomfort, or dehiscence, but no suppuration; and score 3 = poor healing with significant edema, erythema, discomfort, flap dehiscence, or suppuration. [Time Frame: 2 weeks post-treatment].
Tissue appearance: This parameter will be scored according to the consistency, contour, color match, keloid formation degree, and contiguity of the treated sites at T3. Consistency will be rated as firm (1p) or spongy (0p); contour as the presence (2p) or absence (0p) of knife-edged and scalloped GM; color match as excellent (3p), good (2p), adequate (1p), or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); and contiguity as the presence (1p) or absence (0p) of each perceptible incision mark [Time Frame: 6 and 12 months post-treatment].
Aesthetic evaluation: Aesthetics will be evaluated according to the five variables of root coverage esthetic score (RES): GM position, marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). GM position was scored as 0, 3, or 6, whereas each other variable was scored as 0 or 1 [Time Frame: 6 and 12 months post-treatment].
Dentin hypersensitivity: Hypersensitivity will be recorded using a visual analog scale (VAS) (0 = no pain, 10 = extreme pain) after 3-s air blast applied to the cervical portions of the included sites from a triple syringe [Time Frame: Baseline, 6, and 12 months post-treatment].
Eligibility criteria Minimum Age: 18 Years Maximum Age: 60 Years Sex: All Gender Based: No Accepts Healthy Volunteers: Yes
Inclusion Criteria:
Participants aged 18 to 60 years. Individuals with the gingival recession of Miller Class I, II, or III in at least one tooth in the anterior mandibular or maxillary region.
Participants must have at least 1 mm of keratinized tissue width around the affected tooth/tooth and be in good general health.
Ability to provide informed consent for participation in the study.
Exclusion Criteria:
Individuals with uncontrolled systemic diseases that could impact periodontal healing (e.g., diabetes mellitus, cardiovascular diseases).
Current smokers or those who have quit smoking less than 6 months before the study.
Women who are pregnant or breastfeeding. Participants who have received periodontal or gingival recession treatment in the study area within the last year.
Presence of acute periodontal or dental infections requiring immediate treatment, or extensive caries affecting the study teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized controlled trial compares two gingival recession treatments: Coronally Advanced Flap (CAF) with Connective Tissue Graft (CTG) versus Modified Coronally Advanced Tunnel (MCAT) with CTG. Participants are randomized 1:1 to either intervention. Outcomes assessors are blinded to allocation, ensuring unbiased evaluation of the primary outcome, Anatomical Recession Rate (ARR), and secondary clinical outcomes over a 12-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) | Experimental | Procedure: Coronally Positioned Flap with Connective Tissue GraftParticipants in this arm will receive a Coronally Positioned Flap (CPF) surgery combined with a Connective Tissue Graft (CTG). The CPF technique involves surgically repositioning the gum tissue to cover exposed root surfaces, while the CTG procedure involves transplanting connective tissue to the area of gingival recession to encourage regeneration and coverage of exposed roots. This arm aims to evaluate the effectiveness of CPF with CTG in improving gingival recession and periodontal health. |
| Modified Coronally Advanced Tunnel (MCAT) with Connective Tissue Graft (CTG) | Experimental | Procedure: Modified Coronally Advanced Tunnel with Connective Tissue GraftThis arm involves participants receiving the Modified Coronally Advanced Tunnel (MCAT) procedure along with a Connective Tissue Graft (CTG). The MCAT technique is a less invasive approach that creates a tunnel under the gum through which the connective tissue graft is placed without making significant incisions. This method aims to treat gingival recession by encouraging gum regeneration over the exposed roots, with the goal of improving periodontal outcomes and reducing recession. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants aged 18 to 60 years.
- Individuals with the gingival recession of Miller Class I, II, or III in at least one tooth in the anterior mandibular or maxillary region.
- Participants must have at least 1 mm of keratinized tissue width around the affected tooth/tooth and be in good general health.
- Ability to provide informed consent for participation in the study.
Key exclusion criteria (5 listed)
- Individuals with uncontrolled systemic diseases that could impact periodontal healing (e.g., diabetes mellitus, cardiovascular diseases).
- Current smokers or those who have quit smoking less than 6 months before the study.
- Women who are pregnant or breastfeeding.
- Participants who have received periodontal or gingival recession treatment in the study area within the last year.
- Presence of acute periodontal or dental infections requiring immediate treatment, or extensive caries affecting the study teeth.
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 Positioned Flap with Connective Tissue Grafthis intervention involves surgically repositioning the gum tissue over the exposed tooth root and adding a connective tissue graft. The graft is obtained from the patient's palate and placed in the area of gingival recession to promote tissue regeneration and enhance root coverage. The procedure aims to reduce gingival recession and improve periodontal health. | Procedure or surgery | Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) |
| Modified Coronally Advanced Tunnel with Connective Tissue GraftThis intervention utilizes a minimally invasive technique to create a tunnel beneath the gum tissue, through which a connective tissue graft is placed. The graft, sourced from the patient's palate, is used to encourage the growth of new gum tissue over the exposed root. This method is designed to minimize trauma and promote faster recovery, aiming to improve root coverage and periodontal outcomes. | Procedure or surgery | Modified Coronally Advanced Tunnel (MCAT) with Connective Tissue Graft (CTG) |
Primary outcome
Anatomical Recession Rate (ARR)
Time frame: 12 months post-treatment
The primary outcome measure is the Anatomical Recession Rate (ARR), which quantifies the effectiveness of the Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) and the Modified Coronally Advanced Tunnel (MCAT) with CTG in covering exposed root surfaces. ARR is calculated by measuring the linear distance between the gingival margin and the cementoenamel junction before and after treatment, with improvements in ARR indicating successful root coverage.
7 secondary outcomes
Clinical Attachment Level (CAL)
Time frame: Baseline, 3, 6, and 12 months post-treatment
Gingival Thickness (GT)
Time frame: Baseline and 12 months post-treatment
Keratinized Tissue Thickness (KTT)
Time frame: Baseline, 3, 6, and 12 months post-treatment
Wound healing index (WHI)
Time frame: 2 weeks post-treatment
Tissue appearance
Time frame: 6 and 12 months post-treatment
Aesthetic evaluation
Time frame: 6 and 12 months post-treatment
Dentin hypersensitivity
Time frame: Baseline, 6, and 12 months post-treatment
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 13 Mar 2025.
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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.
Gencay Keceli, PHD principal investigator
Hacettepe University
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 Positioned Flap with Connective Tissue Graft and Modified Coronally Advanced Tunnel with Connective Tissue Graft in people with Gingival Recession, 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 4 inclusion and 5 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 Mar 2025. 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?
Anatomical Recession Rate (ARR) (time frame: 12 months post-treatment). 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 13 Mar 2025.