Cor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions

Gingival Recession, Generalized Clinical Trial

Official title:

Coronally Advanced Flap and Envelope Type of Flap Plus Acellular Dermal Matrix Graft for the Treatment of Thin Phenotype Multiple Recession Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883438
• Other study ID #: AZETR201520171001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: February 15, 2015

Study information

• Verified date: March 2019
• Source: Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 15, 2015
• Est. primary completion date: January 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Generalized

Intervention

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

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors	Altinbas University, Universidad El Bosque, Bogotá, Universidade Ibirapuera

Countries where clinical trial is conducted

Azerbaijan,  Brazil,  Colombia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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