Gingival Recessions, Generalized
Conditions
Brief summary
Modification of the periodontal soft tissue phenotype and coverage of exposed root surfaces in patients who have undergone orthodontic treatment.
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.
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).
Sponsors
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
* Smokers * Pregnancy * Poor adherence to oral hygiene practices * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete root coverage (CRC) | 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. |
| Root coverage esthetic score (RES) | 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. |
| Mean root coverage | 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. |
| Patient satisfaction score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | 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 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. |
| Gingival Index | 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 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. |
| Bleeding on Probing | 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. |
| Probing Depth | 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. |
| Clinical Attachment Level | 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 |
| Recession Depth | 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 |
| Recession Width | 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 |
| Gingival Thickness | 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. |
| Keratinized Tissue Width | 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. |
| Oral Health Impact Profile-14 (OHIP-14) | 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 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 |
Countries
Azerbaijan
Contacts
CONTACTVafa Khanmammadova
Outcome results
None listed