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

NCT03883438 | Completed DMC

• 1 other identifier: AZETR201520171001
• Study Type: interventional
• Target: 22
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

Gingival Recession, Generalized

Keywords

Gingival recession; Therapy; Surgery; Tooth root; Surgical flaps; Acellular dermis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Plaque Index

  12 months

• Gingival Index

  12 months

• Bleeding on Probing

  12 months

• Probing Depth

  12 months

• Clinical Attachment Level

  12 months

Study Arms (2)

Coronally advanced flap and acellular dermal graft

ACTIVE COMPARATOR

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

Modified coronally advanced flap and acellular dermal graft

EXPERIMENTAL

Test group received CAF avoiding vertical releasing incisions (mCAF).

Procedure: Modified coronally advanced flap and acellular dermal matrix graft

Interventions

Modified coronally advanced flap and acellular dermal matrix graft PROCEDURE

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

Coronally advanced flap and acellular dermal graft; Modified coronally advanced flap and acellular dermal graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors: lead
• Altinbas University: collaborator
• Universidade Ibirapuera: collaborator
• Universidad El Bosque, Bogotá: collaborator

Study Sites (4)

Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

Baku, Azerbaijan

Location

Ibirapuera University

São Paulo, Brazil

Location

El Bosque University

Bogotá, Colombia

Location

Altinbas University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Cavid Ahmedbeyli, PhD

  Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 20, 2019
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 15, 2015
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1); AZ (1); BR (1); TU (1)