- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03883438
Cor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions
Coronally Advanced Flap and Envelope Type of Flap Plus Acellular Dermal Matrix Graft for the Treatment of Thin Phenotype Multiple Recession Defects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Baku, Azerbaijan
- Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
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San Paolo, Brazil
- Ibirapuera University
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Bogota, Colombia
- El Bosque University
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Istanbul, Turkey
- Altinbas University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Systemically healthy patients
- Miller Class I & II multiple buccal recession defects ≥ 3 mm on maxillary incisors, canines or premolars
- Esthetic indication for root coverage
- Probing depth < 3mm at the recession sites
Exclusion Criteria:
- Smokers
- Pregnancy
- Bruxism and occlusal trauma
- Previous root coverage procedure
- Endodontically treated teeth at the recession sites
- Caries or restorations at the recession sites
- Use of antibiotics over the previous 3 months prior to treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Coronally advanced flap and acellular dermal graft
In CAF group, after local anesthesia oblique beveled vertical incisions were made at the most mesial and distal line angles of the recessions.
These two incisions were connected with an intra-sulcular and interdental sub-marginal incisions in order to create the external surgical papillae.
Then the flap was elevated as a split-full-split approach.
The apical portion of the flap was reflected as close to the periosteum as possible by mesio-distal and apical sharp dissection parallel to the mucosa to release residual muscle tension and extended beyond the muco-gingival junction to facilitate the passive coronal replacement of the flap over the defects.
In both groups ADMG was used as a sub-epithelial graft considering the manufacturer's instructions.
The graft was positioned at the level of cemento-enamel junction and extended to the surrounding bone in the apical direction with full closure of the exposed root surfaces.
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Evaluation of the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I&II ≥3 mm) treated with coronally advanced flap and acellular dermal matrix graft
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Experimental: Modified coronally advanced flap and acellular dermal graft
Test group received CAF avoiding vertical releasing incisions (mCAF).
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Evaluation of the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I&II ≥3 mm) treated with coronally advanced flap and acellular dermal matrix graft
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Complete root coverage
Time Frame: 12 months
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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.
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12 months
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Root coverage esthetic score
Time Frame: 12 months
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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.
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12 months
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Patient satisfaction score
Time Frame: 12 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plaque Index
Time Frame: 12 months
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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
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12 months
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Gingival Index
Time Frame: 12 months
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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
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12 months
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Bleeding on Probing
Time Frame: 12 months
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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.
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12 months
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Probing Depth
Time Frame: 12 months
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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.
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12 months
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Clinical Attachment Level
Time Frame: 12 months
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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
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12 months
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Recession Depth
Time Frame: 12 months
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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
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12 months
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Recession Width
Time Frame: 12 months
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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
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12 months
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Gingival Thickness
Time Frame: 12 months
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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.
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12 months
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Keratinized Tissue Width
Time Frame: 12 months
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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.
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12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Cavid Ahmedbeyli, PhD, Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZETR201520171001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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