Two Surgical Approaches for Root Coverage of Teeth Presenting Gingival Recession and Non-carious Cervical Lesion

NCT03341598 | Completed

• 1 other identifier: UEPJMF 8
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to compare the use of the xenogeneic graft (MC) plus coronary advanced flap (CAF) and the coronary advanced flap alone, both associated with the partial restoration of composite resin in the treatment of gingival recessions associated with non-carious cervical lesion.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Recession reduction

  Recession reduction from baseline measured in millimetres

  1 year

Secondary Outcomes (1)

• Root coverage esthetic score

  6 months

Study Arms (2)

CAF+R

ACTIVE COMPARATOR

First of all, a sterile rubber dam will be placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M- St. Paul, Minnesota, USA), following the manufacturer's instructions. CAF treatment will be performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision will be made to unite the releasing incisions and the flap will be raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures will be placed to stabilize the flap in a coronal position 2 mm above the cementoenamel junction (CEJ), followed by interrupted sutures to close the releasing incisions.

Procedure: CAF; Procedure: R

CAF+R+MC

EXPERIMENTAL

First of all, a sterile rubber dam will be placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M - St. Paul, Minnesota, USA), following the manufacturer's instructions. CAF treatment will be performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision will be made to unite the releasing incisions and the flap will be raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Additionally, this group will receive the xenogenous collagen matrix graft (Geistlich) on the recessed area before the sutures. Then, the flap will be coronally positioned and sutured to completely cover the graft.

Procedure: CAF; Procedure: R; Procedure: MC

Interventions

CAF PROCEDURE

Periodontal surgical technique to treat gingival recessions.

Also known as: Periodontal plastic surgery

CAF+R; CAF+R+MC

R PROCEDURE

Restorative procedure to treat tooth structure loss.

Also known as: Composite resin restoration (Filtek Supreme - 3M)

CAF+R; CAF+R+MC

MC PROCEDURE

Xenogenous graft placed in the surgical site.

Also known as: Xenogenous collagen matrix

CAF+R+MC

Eligibility Criteria

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

You may qualify if:

• presenting Miller class I or II gingival recession in the maxillary canines or premolars associated with non-carious cervical lesion;
• teeth included in the study should present pulp vitality;
• patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
• patients older than 18 years old;
• probing depth ˂ 3 mm in the included teeth;
• patients who agreed to participate and signed an informed consent form

You may not qualify if:

• patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
• patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
• smokers or pregnant women
• patients who underwent periodontal surgery in the area of interest;

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

São Paulo State University

São José dos Campos, São Paulo, 12245000, Brazil

Location

Related Publications (3)

• Zucchelli G, Gori G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Non-carious cervical lesions associated with gingival recessions: a decision-making process. J Periodontol. 2011 Dec;82(12):1713-24. doi: 10.1902/jop.2011.110080. Epub 2011 May 4.

  PMID: 21542735 BACKGROUND

• Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.

  PMID: 27834120 BACKGROUND

• Mathias-Santamaria IF, Silveira CA, Rossato A, Sampaio de Melo MA, Bresciani E, Santamaria MP. Single gingival recession associated with non-carious cervical lesion treated by partial restoration and coronally advanced flap with or without xenogenous collagen matrix: A randomized clinical trial evaluating the coverage procedures and restorative protocol. J Periodontol. 2022 Apr;93(4):504-514. doi: 10.1002/JPER.21-0358. Epub 2021 Aug 21.

  PMID: 34310715 DERIVED

MeSH Terms

Conditions

Gingival Recession

Interventions

Filtek Supreme

Condition Hierarchy (Ancestors)

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

Study Officials

• Mauro P Santamaria, PhD

  ICT-UNESP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: November 14, 2017
• Study Start: February 1, 2017
• Primary Completion: May 4, 2018
• Study Completion: July 27, 2018
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

BR (1)