Surgical Treatment for Gingival Recessions After Orthodontic Treatment

NCT07763808 | Recruiting Phase 2

• 1 other identifier: AZEADHTI202505154
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Modification of the periodontal soft tissue phenotype and coverage of exposed root surfaces in patients who have undergone orthodontic treatment.

Conditions

Gingival Recessions, Generalized

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  12 months

Secondary Outcomes (10)

• Plaque Index

  12 months

• Gingival Index

  12 months

• Bleeding on Probing

  12 months

• Probing Depth

  12 months

• Clinical Attachment Level

  12 months

Study Arms (3)

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).

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).

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.

Procedure: Coronally advanced flap and Mucoderm soft tissue collagen graft

Interventions

Coronally advanced flap and a de-epithelialized soft tissue graft PROCEDURE

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).

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

Coronally advanced flap and a subepithelial connective tissue graft PROCEDURE

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 a subepithelial connective tissue graft.

Coronally advanced flap and Mucoderm soft tissue collagen graft PROCEDURE

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).

Coronally advanced flap and Mucoderm soft tissue collagen graft.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors: lead

Study Sites (1)

Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

Baku, Azerbaijan

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Vafa Khanmammadova

CONTACT

+994504374622; vafa.xanmammadova@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A total of 75 participants will be randomly allocated to the treatment groups using a computer-generated randomization sequence by an independent individual not involved in the study. Allocation concealment will be ensured through the use of sequentially numbered, sealed, opaque envelopes. Each envelope will contain the assigned treatment for a specific participant. Both the participants and the investigator will remain blinded to the group allocation prior to the surgical intervention. The envelope will be opened by the surgeon immediately before the procedure, at which point the assigned technique will be revealed. Outcome assessment will be performed by an independent examiner blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

AZ (1)