Back to resultsCor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions
Primary Purpose
Gingival Recession, Generalized
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Modified coronally advanced flap and acellular dermal matrix graft
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Generalized focused on measuring Gingival recession, Therapy, Surgery, Tooth root, Surgical flaps, Acellular dermis
Eligibility Criteria
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
Sites / Locations
- Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
- Ibirapuera University
- El Bosque University
- Altinbas University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Coronally advanced flap and acellular dermal graft
Modified coronally advanced flap and acellular dermal graft
Arm Description
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.
Test group received CAF avoiding vertical releasing incisions (mCAF).
Outcomes
Primary Outcome Measures
Complete root coverage
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
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.
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).
Secondary Outcome Measures
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
- 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.
- 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.
- Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
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
- Mild inflammation, slight change in color, slight edema; no bleeding on probing (BoP)
- Moderate inflammation, redness, edema, and glazing; bleeding on probing
- Severe inflammation, marked redness and edema, ulcerations; tendency to spontaneous bleeding.
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.
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.
Clinical Attachment Level
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
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
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
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
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.
Full Information
NCT ID
NCT03883438
First Posted
March 17, 2019
Last Updated
March 25, 2019
Sponsor
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Collaborators
Altinbas University, Universidade Ibirapuera, Universidad El Bosque, Bogotá
1. Study Identification
Unique Protocol Identification Number
NCT03883438
Brief Title
Cor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions
Official Title
Coronally Advanced Flap and Envelope Type of Flap Plus Acellular Dermal Matrix Graft for the Treatment of Thin Phenotype Multiple Recession Defects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
January 1, 2015 (Actual)
Study Completion Date
February 15, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Collaborators
Altinbas University, Universidade Ibirapuera, Universidad El Bosque, Bogotá
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical evaluation of conventional and modified coronally advanced flaps combined with acellular dermal matrix graft
Detailed Description
The aim of this study was to evaluate the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I&II ≥3 mm) treated with coronally advanced flap (CAF) and acellular dermal matrix graft (ADMG) in 22 eligible participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Generalized
Keywords
Gingival recession, Therapy, Surgery, Tooth root, Surgical flaps, Acellular dermis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 22 patients with 55 recessions were included in this single blind randomized controlled trial. Each patient had at least two recessions with a depth of ≥ 3 mm (Miller Class I&II) in the upper jaw. The entry criteria were esthetic indication for root coverage; absence of caries or restorations at the selected sites; no history of previous mucogingival therapy; being a non-smoker and a systemically healthy patient.
Masking
Participant
Masking Description
A computer program was used to randomize 22 volunteers to treatment groups by a person who was not involved in the study. The result of this randomization process was written on a paper and then put in the sealed opaque envelope by a blinded examiner, in which the treatment procedure for the specific patient was defined. The envelope was opened by surgeon, immediately before starting the surgical procedure.
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coronally advanced flap and acellular dermal graft
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Modified coronally advanced flap and acellular dermal graft
Arm Type
Experimental
Arm Description
Test group received CAF avoiding vertical releasing incisions (mCAF).
Intervention Type
Procedure
Intervention Name(s)
Modified coronally advanced flap and acellular dermal matrix graft
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete root coverage
Description
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
Title
Root coverage esthetic score
Description
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
Title
Patient satisfaction score
Description
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 Outcome Measure Information:
Title
Plaque Index
Description
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
- 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.
- 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.
- Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Time Frame
12 months
Title
Gingival Index
Description
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
- Mild inflammation, slight change in color, slight edema; no bleeding on probing (BoP)
- Moderate inflammation, redness, edema, and glazing; bleeding on probing
- Severe inflammation, marked redness and edema, ulcerations; tendency to spontaneous bleeding.
Time Frame
12 months
Title
Bleeding on Probing
Description
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
Title
Probing Depth
Description
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
Title
Clinical Attachment Level
Description
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
Title
Recession Depth
Description
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
Title
Recession Width
Description
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
Title
Gingival Thickness
Description
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
Title
Keratinized Tissue Width
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cavid Ahmedbeyli, PhD
Organizational Affiliation
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
City
Baku
Country
Azerbaijan
Facility Name
Ibirapuera University
City
San Paolo
Country
Brazil
Facility Name
El Bosque University
City
Bogota
Country
Colombia
Facility Name
Altinbas University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Cor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions
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