Influence of Anatomical Factors Upon Root Coverage

NCT04813302 | Completed

• 1 other identifier: PER-ECL-2019-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Gingival recession is a lesion characterized by the loss of attachment of root surface of the tooth, resulting in an apical migration of the gingival margin that occasionally generates aesthetic problems, hypersensitivity and difficulty in maintaining proper hygiene. Several anatomical factors have been associated both with the incidence and progression of gingival recession and with the prognosis of the surgical treatments proposed for its correction. These factors include the absence of keratinized tissue, the gingival phenotype, root prominence and shallow vesrtibular depth. Objectives: The objective of the study is to evaluate, through a series of prospective cases, the influence of each of the anatomical factors on the success of root coverage. Methods: 20 patients with gingival recession defects will be treated with CAF+CTG using various autogenous gingival graft. Three-dimensional analysis of superimposed preoperative and postoperative images will be performed. Linear and surface root coverage will be calculated and correlated to various anatomical parameters such as vestibular depth and root prominence. A multilevel statistical analysis will be conducted, adjusting for the correlation among multiple observations.

Conditions

Gingival Recession; Gingival Diseases; Periodontal Attachment Loss

Outcome Measures

Primary Outcomes (1)

• Complete Root Coverage

  By using the buccal surfaces of the concerned teeth as reference points for the superimposition of the different time points (pre-operative and post-operative), this approach will allow for the precise evaluation of dimensional soft tissue alterations over time.

  6 months

Secondary Outcomes (1)

• Mean Root Coverage

  6 months

Study Arms (1)

Gingival recession treatment

EXPERIMENTAL

Gingival recession treatment by means of a coronally advanced flap and a connective tissue graft

Procedure: Coronally advanced flap and connective tissue graft

Interventions

Coronally advanced flap and connective tissue graft PROCEDURE

CAF+CTG treatment will be performed by starting with two vertical releasing incisions lateral to the teeth to be treated and split-full-split thickness flap will be raised beyond the MGJ. The periosteum will be cut, and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the tooth. The papillae adjacent to the involved teeth will be de-epithelialized. CTG of 1mm in thickness will be harvested from the posterior palate by means of disepithelization of a free gingival graft, cut to the exact size of the defect, and placed over the dehisced defect, sutured to the interdental papillae and subsequently covered with CAF. Sling sutures will be placed to stabilize the flap in a coronal position about 1-2 mm above the CEJ , followed by interrupted sutures to close the releasing incisions.

Gingival recession treatment

Eligibility Criteria

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

You may qualify if:

• ≥18 years.
• Periodontally and systemically healthy.
• Presence of Miller class I and II GR defects or class III with no interproximal clinical attachment loss.
• Recession \>2mm in depth at the buccal aspect.
• Full-mouth plaque and bleeding score ≤20%.
• No previous periodontal surgery.
• Presence of identifiable CEJ (a step ≤1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).

You may not qualify if:

• Tobacco smoking of ≥10 cigarettes a day.
• Contraindications for periodontal surgery.
• Medications known to affect the gingiva or interfere with wound healing.
• Pregnancy.
• Active orthodontic therapy.
• caries or restorations in the area to be treated.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

International University of Catalunya

Barcelona, 08172, Spain

Location

MeSH Terms

Conditions

Gingival Recession; Gingival Diseases; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Jose Nart, DDS PhD

  Universitat Internacional de Catalunya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 24, 2021
• Study Start: September 15, 2019
• Primary Completion: December 15, 2020
• Study Completion: March 15, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

ES (1)