Gingival Recessions, GeneralizedPhase 2/3NCT07763808
Surgical Treatment for Gingival Recessions After Orthodontic Treatment
A Phase 2/3 study testing Coronally advanced flap and a de-epithelialized soft tissue graft, Coronally advanced flap and a subepithelial connective tissue graft and Coronally advanced flap and Mucoderm soft tissue collagen graft in people with Gingival Recessions, Generalized, run by Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors at 1 site in Azerbaijan.
Trial summary
Modification of the periodontal soft tissue phenotype and coverage of exposed root surfaces in patients who have undergone orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recessions, Generalized
- What is being tested?
- Coronally advanced flap and a de-epithelialized soft tissue graft, Coronally advanced flap and a subepithelial connective tissue graft and Coronally advanced flap and Mucoderm soft tissue collagen graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 1 Sep 2026to 1 Nov 2027
- Phase
- Phase 2/3
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy patients
- RT1 and RT2 gingival recession defects according to the Cairo classification, with recession depth ≥ 2 mm
- Completed orthodontic treatment
- Aged between 18 and 70
Who cannot join
- Smokers
- Pregnancy
- Poor adherence to oral hygiene practices
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Azerbaijan1 site, 1 recruiting
- Recruiting
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Baku
Vafa Khanmammadova, +994504374622, vafa.xanmammadova@gmail.com
About this study
Official title: Improvement of Surgical Approaches for the Management of Gingival Recessions in Patients After Orthodontic Treatment
Modification of the periodontal soft tissue phenotype and coverage of exposed root surfaces in patients who have undergone orthodontic treatment.
Read the detailed description
This study aims to determine and implement the optimal treatment approach for gingival recession defects (GRDs) developing during orthodontic therapy through a comparative analysis of different surgical treatment techniques. It also aims to explore the key aspects of managing GRDs and sites with inadequate keratinized gingiva in orthodontic patients, including risk assessment, diagnosis, treatment indications, the role of soft tissue phenotype modification, the progression of gingival recession during orthodontic tooth movement, and the optimal sequencing of periodontal and orthodontic therapies to achieve stable functional and esthetic outcomes.
- Conditions
- Gingival Recessions, Generalized
- Being tested
- Coronally advanced flap and a de-epithelialized soft tissue graft, Coronally advanced flap and a subepithelial connective tissue graft, Coronally advanced flap and Mucoderm soft tissue collagen 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 advanced flap and a de-epithelialized soft tissue graftProcedure or surgery
Evaluation of the effectiveness of coronally advanced flap combined with a de-epithelialized soft tissue graft in the management of multiple gingival recessions (Cairo classification RT1 and RT2 ≥ 2 mm).
Coronally advanced flap and a subepithelial connective tissue graftProcedure or surgery
Evaluation of the effectiveness of coronally advanced flap combined with a subepithelial connective tissue graft in the management of multiple gingival recessions (Cairo classification RT1 and RT2 ≥ 2 mm).
Coronally advanced flap and Mucoderm soft tissue collagen graftProcedure or surgery
Evaluation of the effectiveness of coronally advanced flap combined with a Mucoderm soft tissue collagen graft in the management of multiple gingival recessions (Cairo classification RT1 and RT2 ≥ 2 mm).
| Study group | Role | What they receive |
|---|---|---|
| Group I: Coronally advanced flap and a de-epithelialized soft tissue graft. | Active comparator | Patients in Group I who have completed orthodontic treatment will receive a coronally advanced flap and a de-epithelialized soft tissue graft to modify the periodontal soft tissue phenotype and cover exposed root surfaces caused by gingival recession.Evaluation of the effectiveness of coronally advanced flap combined with a de-epithelialized soft tissue graft in the management of multiple gingival recessions (Cairo classification RT1 and RT2 ≥ 2 mm). Receives: Procedure: Coronally advanced flap and a de-epithelialized soft tissue graft |
| Coronally advanced flap and a subepithelial connective tissue graft. | Active comparator | Patients in Group II will receive a coronally advanced flap and a subepithelial connective tissue graft for the same purpose. Evaluation of the effectiveness of coronally advanced flap combined with a subepithelial connective tissue graft in the management of multiple gingival recessions (Cairo classification RT1 and RT2 ≥ 2 mm). Receives: Procedure: Coronally advanced flap and a subepithelial connective tissue graft |
| Coronally advanced flap and Mucoderm soft tissue collagen graft. | Experimental | Patients in Group III will receive a coronally advanced flap and a Mucoderm soft tissue collagen graft. Evaluation of the effectiveness of coronally advanced flap combined with a Mucoderm soft tissue collagen graft in the management of multiple gingival recessions (Cairo classification RT1 and RT2 ≥ 2 mm). In all three groups, surgical interventions will be performed after completion of orthodontic treatment.
Gingival thickness will be evaluated before treatment and at 6 and 12 months postoperatively. Root coverage, esthetic parameters, and patient satisfaction will be assessed 12 months after treatment. Receives: Procedure: Coronally advanced flap and Mucoderm soft tissue collagen graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete root coverage (CRC)
Complete defect coverage was calculated as the percentage of patients with defects having complete coverage achieved as the gingival margin at cemento-enamel junction or coronal level.
Measured: 12 months
Root coverage esthetic score (RES)
Root coverage esthetic score (RES) was used as a scoring system to assess the esthetic outcomes following root coverage procedures on Miller Class I \& II gingival recession defects through the evaluation of clinical cases. Gingival margin level, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color were evaluated without magnification. Zero, 3 and 6 points were used for the evaluation of the position of the gingival margin, whereas a score 0 or 1 point was used for each of the other variables.
Measured: 12 months
Mean root coverage
Mean root coverage refers to the average amount of exposed tooth root that becomes covered again by gum tissue after periodontal treatment for gum recession, calculated as a percentage or millimeters. It is used to evaluate how successful the treatment is in restoring gum coverage, improving aesthetics, and protecting the root surface.
Measured: 12 months
Patient satisfaction score
Each patient was questioned about his/her satisfaction with regard to the following patient-centered criteria:
Root coverage attained, relief from dentinal hypersensitivity, color of gums, shape and contour of gums, surgical procedure in terms of pain during surgery and the discomfort experienced related to the duration of the procedure and handling by the operator, post surgical phase in terms of the pain, swelling, and postoperative complications; and cost effectiveness in terms of the time and money spent for the treatment.
Patient satisfaction was assessed using a three-point rating scale: fully satisfied (3 points); satisfied (2 points); and unsatisfied (1 point).
Measured: 12 months
Secondary outcomes (10)
Plaque Index
Teeth were isolated by cotton rolls and after drying by air syringe, the microbial dental plaque was evaluated by the explorer from 4 tooth surfaces (mesio-buccal, mid-buccal, disto-buccal and mid-palatinal) and scores between 0- 3 were given for each point.
Scoring was made as follows:
0 - No microbial dental plaque in the gingival area
- - A film of microbial dental plaque adhering to the free gingival margin and adjacent area of the tooth, recognized only by running a probe across the tooth surfaces.
- - Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth surfaces that can be seen by the naked eye.
- - Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: 12 months
Gingival Index
The periodontal probe was used to assess the bleeding potential of the tissues from 4 tooth surfaces (mesio-buccal papilla, mid-buccal margin, disto- buccal papilla and mid-palatinal margin) and scores between 0 - 3 were given for each point.
Scoring was made as follows: 0 - Normal gingiva
- - Mild inflammation, slight change in color, slight edema; no bleeding on probing (BoP)
- - Moderate inflammation, redness, edema, and glazing; bleeding on probing
- - Severe inflammation, marked redness and edema, ulcerations; tendency to spontaneous bleeding.
Measured: 12 months
Bleeding on Probing
The periodontal probe was used to assess the percentage of bleeding after probing from 4 tooth surfaces (mesio-buccal papilla, mid-buccal margin, disto-buccal papilla and mid-palatinal margin) and scored as positive (+) or negative (-) bleeding for each point.
Measured: 12 months
Probing Depth
Probing Depth of the recession defect was measured in mm by the periodontal probe at the mid buccal surface of the related tooth as the distance between the gingival margin and the bottom of the gingival sulcus.
Measured: 12 months
Clinical Attachment Level
Clinical Attachment Level of the recession defect was measured in mm by the periodontal probe at the mid-buccal surface of the related tooth and it was defined as the distance between the cemento-enamel junction and the bottom of the gingival sulcus
Measured: 12 months
Recession Depth
Recession Depth was measured in mm by the periodontal probe at the mid-buccal surface of the related tooth as the distance between the cemento-enamel junction and the most apical point of the gingival margin
Measured: 12 months
Recession Width
Recession Width of the defect was measured in mm by the periodontal probe as the horizontal distance from one border of the recession to another in mesio-distal direction at the level of the cemento-enamel junction
Measured: 12 months
Gingival Thickness
Gingival Thickness was measured in mm at the mid-point location between the gingival margin and mucogingival junction, using an #25 endodontic spreader. Under the local anesthesia, the spreader was pierced perpendicularly to the mucosal surface, through the soft tissue with light pressure until hard surface was felt. The silicone disk stop was placed in tight contact with the external soft tissue surface. After carefully removing the spreader, penetration depth was measured with a digital caliper5 with 0.05 resolution.
Measured: 12 months
Keratinized Tissue Width
Keratinized Tissue Width of the recession defect was measured in mm by the periodontal probe at the same point as the probing depth, clinical attachment level and recession depth.
Measured: 12 months
Oral Health Impact Profile-14 (OHIP-14)
Each patient was questioned about his/her satisfaction with regard to the following patient-centered criteria:
Functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, handicap
Each question is usually scored on a 5-point Likert scale:
0 - Never
- - Hardly ever
- - Occasionally
- - Fairly often
- - Very often Sum all 14 item scores. Total range: 0-56 Higher scores = poorer oral health-related quality of life 0-14: little or no impact 15-28: moderate impact 29-42: substantial impact 43-56: severe impact
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recessions, GeneralizedStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 75 patients with gingival recessions will be included in this single-blind randomized controlled trial. Each patient will have at least two recessions with a depth of ≥2 mm (Cairo classification RT1 and RT2). The inclusion criteria will be esthetic indication for root coverage, completed orthodontic treatment, non-smoking status, and systemic health.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vafa Khanmammadova, Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763808
- Sponsor's protocol ID
- AZEADHTI202505154
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No