Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Baku, Azerbaijan
Location status: Recruiting
NCT Number: NCT07763808
Modification of the periodontal soft tissue phenotype and coverage of exposed root surfaces in patients who have undergone orthodontic treatment.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 2 / Phase 3
Baku, Azerbaijan
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
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).
Time frame: 12 months
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
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
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
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
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
Time frame: 12 months
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
Time frame: 12 months
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
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
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
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Other
Improvement of Surgical Approaches for the Management of Gingival Recessions in Patients After Orthodontic Treatment
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