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RecruitingNCT07763808Updated Aug 13, 2026

Surgical Treatment for Gingival Recessions After Orthodontic Treatment

A Phase 2/3 interventional study of Coronally advanced flap and a de-epithelialized soft tissue graft and Coronally advanced flap and a subepithelial connective tissue graft in Gingival Recessions, Generalized, sponsored by Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors. Recruiting at 1 site in Azerbaijan. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Gingival Recessions, Generalized

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03

In context

Gingival Recession

426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.

This study's planned enrollment of 75 is above the median of 30 across 390 interventional studies indexed under Gingival Recession.

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Lead sponsor

Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Smokers
  • Pregnancy
  • Poor adherence to oral hygiene practices
  • Refusal to participate in the study
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (estimated)

Study arms

  • Active comparator
    Group I: Coronally advanced flap and a de-epithelialized soft tissue graft.

    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).

    Procedure: Coronally advanced flap and a de-epithelialized soft tissue graft

  • Active comparator
    Coronally advanced flap and a subepithelial connective tissue graft.

    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).

    Procedure: Coronally advanced flap and a subepithelial connective tissue graft

  • Experimental
    Coronally advanced flap and Mucoderm soft tissue collagen graft.

    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.

    Procedure: Coronally advanced flap and Mucoderm soft tissue collagen graft

Interventions

  • ProcedureCoronally advanced flap and a de-epithelialized soft tissue graft

    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).

  • ProcedureCoronally advanced flap and a subepithelial connective tissue graft

    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).

  • ProcedureCoronally advanced flap and 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

  4. 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).

    Time frame: 12 months

Secondary outcomes

  1. 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 1. \- 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. 2. \- 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. 3. \- Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

    Time frame: 12 months

  2. 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 1. \- Mild inflammation, slight change in color, slight edema; no bleeding on probing (BoP) 2. \- Moderate inflammation, redness, edema, and glazing; bleeding on probing 3. \- Severe inflammation, marked redness and edema, ulcerations; tendency to spontaneous bleeding.

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

  4. 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.

    Time frame: 12 months

  5. 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

    Time frame: 12 months

  6. 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

    Time frame: 12 months

  7. 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

    Time frame: 12 months

  8. 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.

    Time frame: 12 months

  9. 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.

    Time frame: 12 months

  10. 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 1. \- Hardly ever 2. \- Occasionally 3. \- Fairly often 4. \- 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

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
    Baku, Azerbaijan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07763808
Lead sponsor
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Responsible party
Vafa Khanmammadova (Researcher, Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors) — Principal investigator
First posted
Aug 13, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Vafa Khanmammadova
Contact
vafa.xanmammadova@gmail.com
+994504374622

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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