Root Coverage With Connective Tissue Graft Associated With VISTA Versus Tunnel Technique

NCT03690635 | Unknown Phase 4 DMC

• 1 other identifier: perio 0102051
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Several techniques were proposed in the literature to solve the problems associated with gingival recession. Root coverage was mainly indicated for esthetic concern, however, it might also be indicated for treatment of root hypersensitivity and maintaining adequate plaque control by keratinized tissue augmentation. These proposed surgical techniques were well-documented with successful outcomes. Each technique had its own advantages, disadvantages and indications. Various factors affected the most suitable technique. These factors were either related to the dimensions of gingival recession defect, or related to the surgeon experience or to the patient himself . Nowadays, the scope of scientific research is concerned with designing surgical techniques that are more predictable, high esthetic, less invasive and patient centered In this way, continuous modification of surgical techniques aroused to result in a more reproducible outcomes; such as the attempt to advance pedicle flaps without vertical releasing incisions, as in the modified coronally advanced flap and the modified microsurgical tunnel technique. However, controversy still exist in the literature regarding the best technique for root coverage. Coronally advanced flap is the most commonly reported technique in research, with lack of researches on tunneling techniques.

Conditions

Root Coverage; Tunneling Technique; VISTA Technique; Sub Epithelial Connective Tissue Graft

Keywords

treatment of gingival recession; root coverage; tunneling technique; VISTA technique; sub epithelial connective tissue graft; recession treatment

Outcome Measures

Primary Outcomes (1)

• post operative edema

  post operative edema will be measured using visual analogue scale (VAS). Visual analogue scales (VAS) are used to measure the intensity or frequency of the symptoms and the pain. They are generally completed by patients themselves. The used scale in this study is a horizontal straight line of a fixed length (100 mm) and numbered every 10 mm ranging from "0 - no pain" to "100 - intolerable pain"

  immediately post operative

Secondary Outcomes (2)

• Percentage of root coverage

  6 month

• Root Coverage Esthetic Score

  6 month

Other Outcomes (4)

• Post-Operative Pain

  immediately post operative

• Gingival Thickness

  6 month

• Gingival Recession Width (RW)

  6 month

Study Arms (2)

VISTA technique

EXPERIMENTAL

evolution of a newer approach known as Vestibular Incision Subperiosteal Tunnel Access (VISTA) was proposed to avoid some of the potential complications occurring with other intrasulcular tunneling techniques

Procedure: VISTA (vestibular incision subperiosteal tunnel acess)

tunneling technique

ACTIVE COMPARATOR

Several modifications of tunnel technique have been described in order to preserve esthetics, avoid relapse of gingival recession and maintain papillary integrity. These modifications also attend to avoid scar formation and delayed healing related to vertical releasing incision

Procedure: VISTA (vestibular incision subperiosteal tunnel acess)

Interventions

VISTA (vestibular incision subperiosteal tunnel acess) PROCEDURE

A vertical incision will be made on the mucous membrane and the periosteum with a scalpel. The incision will be 8-10mm long, beginning from the mobile mucosa and reaching the apical end of the keratinized gingiva. A small subperiosteal elevator will be inserted through the incision and is used to free the subperiosteal tunnel flap. The flap includes the tissues of the mobile and immobile mucosa in the area of the affected teeth and about 1 mm distally and medially from them. Subperiosteal tunnel will be extended interproximally under each papilla as far as the embrasure space permits, without making any surface incisions through the papilla. Tunneling instruments will be used through the vertical incision to free the mucosa and the periosteum around the teeth affected by the gingival recession. This is continues at the base of the gingival papillae without affecting their integrity.

Also known as: vestibular incision subperiosteal tunnel access

VISTA technique; tunneling technique

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients 18 years or older.
• Periodontally and systemically healthy.
• Presence of at least one Miller class I or II buccal gingival recession defect ≥1 and \<6 mm in depth (Miller 1985)
• Teeth to be treated: Upper and lower central and lateral incisors, canine, first and second premolars, and first molar
• Full-mouth plaque and bleeding scores ≤ 20%, no pocket depths \>3 mm, no active periodontal Disease.
• Clinical indication and/or patient request for recession coverage.
• Radiographic evidence of sufficient interdental bone (i.e., the distance between the crestal bone and the cementoenamel junction is not greater than two mm)
• Gingival thickness of at least 0.5mm at a point located three mm below the free gingival margin.
• A minimum of two mm of keratinized gingiva (thick biotype).

You may not qualify if:

• Miller class III or IV recession defects.
• Thin biotype , gingival thickness less than or equal 0.5
• Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
• Handicapped and mentally retarded patients.
• Teeth with cervical restorations, abrasion.
• Patients unable to undergo minor oral surgical procedures.
• Patients with a history of drug or alcohol abuse.
• Patients with a history of psychiatric disorder.
• Pregnant females.
• Uncontrolled periodontal disease or patient unwillingness to undergo needed periodontal therapy around remaining teeth.
• Patients who have any systemic condition that may contraindicate any other surgical procedures such as bleeding disorders, uncontrolled diabetes mellitus and immune compromised patients such as HIV patients.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• Gobbato L, Nart J, Bressan E, Mazzocco F, Paniz G, Lops D. Patient morbidity and root coverage outcomes after the application of a subepithelial connective tissue graft in combination with a coronally advanced flap or via a tunneling technique: a randomized controlled clinical trial. Clin Oral Investig. 2016 Nov;20(8):2191-2202. doi: 10.1007/s00784-016-1721-7. Epub 2016 Jan 27.

  PMID: 26814715 RESULT

Study Officials

• weam battawy, PHD

  Cairo University

  STUDY CHAIR

Central Study Contacts

mustafa Gameel, MSC

CONTACT

+201011183324; mustafagameel22@gmail.com

Mona Shoeib, PHD

CONTACT

01225424241; monashoeib@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 1, 2018
• Study Start: October 10, 2018
• Primary Completion: September 10, 2020
• Study Completion: March 10, 2021
• Last Updated: October 1, 2018

Record last verified: 2018-09