Surgical Treatment for Gingival Recessions After Orthodontic Treatment

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Smokers

Pregnancy

Poor adherence to oral hygiene practices

Refusal to participate in the study

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/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 graft

    Procedure/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 graft

    Procedure/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).

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Group I: Coronally advanced flap and a de-epithelialized soft tissue graft.Active comparator 1 intervention
Group B: Coronally advanced flap and a subepithelial connective tissue graft.Active comparator 1 intervention
Group C: Coronally advanced flap and Mucoderm soft tissue collagen graft.Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

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