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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara, 06100

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06272006
Study groupRoleWhat they receive
Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG)ExperimentalParticipants 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)ExperimentalThis 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted22 Feb 2024
  2. Study start24 Feb 2024
  3. Primary completion4 Feb 2025
  4. Study completion5 Mar 2025

Resources

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)
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

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.

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