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

Clinical evaluation of conventional and modified coronally advanced flaps combined with acellular dermal matrix graft

Study Overview

• Status: Completed
• Conditions: Gingival Recession, Generalized
• Intervention / Treatment: Procedure: Modified coronally advanced flap and 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Azerbaijan
  • Baku, Azerbaijan
    • Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
• Brazil
  • San Paolo, Brazil
    • Ibirapuera University
• Colombia
  • Bogota, Colombia
    • El Bosque University
• Turkey
  • Istanbul, Turkey
    • Altinbas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Modified coronally advanced flap and acellular dermal matrix graft; 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
Experimental: Modified coronally advanced flap and acellular dermal graft; Test group received CAF avoiding vertical releasing incisions (mCAF).	Procedure: Modified coronally advanced flap and acellular dermal matrix graft; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months
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.	12 months
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.	12 months
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	12 months
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	12 months
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	12 months
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
• Collaborators: Universidade Ibirapuera; Universidad El Bosque, Bogotá; Altinbas University
• Investigators: Principal Investigator: Cavid Ahmedbeyli, PhD, Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 15, 2015

Study Registration Dates

• First Submitted: March 17, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Surgery; Gingival recession; Therapy; Tooth root; Surgical flaps; Acellular dermis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: AZETR201520171001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No