Mucoderm® Versus CTG in the Treatment of Multiple Gingival Recessions Associated With Non-carious Cervical Lesion.

NCT03594513 | Unknown

• 1 other identifier: AR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to compare two different multidisciplinary protocols using two types of grafts, porcine acellular dermal matrix (Mucoderm®) versus connective tissue graft, both associated with modified coronally advanced flap, in the treatment of multiple adjacent gingival recessions associated with non-carious cervical lesion partially (NCCL) restored by composite resin.

Conditions

Gingival Recession; Tooth Abrasion

Keywords

Gingival Recession; Tooth Abrasion; Mucoderm

Outcome Measures

Primary Outcomes (1)

• Percentage of defect coverage

  Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.

  6 months

Secondary Outcomes (4)

• Modified root coverage esthetic score

  6 months

• Dentine hypersensitivity

  6 months

• Patient recovery

  14 days

• Patient-centred esthetic evaluation

  6 months

Study Arms (2)

MCAF+PR+CTG

ACTIVE COMPARATOR

The partial restoration of the NCCL will be performed prior the surgeries and will be carried out with composite resin.The surgical procedure for root coverage will be carried out by means modified coronally advanced flap and will be performed by starting with oblique incisions in the interdental areas, which continued with the intrasulcular incision at the recession defects.Each surgical papilla will be dissected in a split-thickness and the envelope flap will be raised with a split-full-split thickness in the coronal-apical direction. Additionally, this group will receive the connective tissue graft harvested from the palate on the recessed area before the sutures.Then, the flap will be coronally positioned and sutured to completely cover the graft.

Procedure: MCAF; Procedure: PR; Procedure: CTG; Drug: Sodium dipyrone; Drug: chlorhexidine rinse

MCAF+PR+XMD(Mucoderm®)

EXPERIMENTAL

The partial restoration of the NCCL will be performed prior the surgeries and will be carried out with composite resin.The surgical procedure for root coverage will be carried out by means modified coronally advanced flap and will be performed by starting with oblique incisions in the interdental areas, which continued with the intrasulcular incision at the recession defects.Each surgical papilla will be dissected in a split-thickness and the envelope flap will be raised with a split-full-split thickness in the coronal-apical direction. Additionally, this group will receive a porcine acellular dermal matrix on the recessed area before the sutures. Then, the flap will be coronally positioned and sutured to completely cover the graft.

Procedure: MCAF; Procedure: PR; Procedure: XMD(Mucoderm®); Drug: Sodium dipyrone; Drug: chlorhexidine rinse

Interventions

MCAF PROCEDURE

Periodontal surgical technique to treat gingival recessions.

Also known as: Periodontal plastic surgery

MCAF+PR+CTG; MCAF+PR+XMD(Mucoderm®)

PR PROCEDURE

Restorative procedure to treat tooth structure loss.

Also known as: Composite resin restoration

MCAF+PR+CTG; MCAF+PR+XMD(Mucoderm®)

CTG PROCEDURE

Autogenous graft harvested from palate placed in the surgical site.

Also known as: Connective tissue graft

MCAF+PR+CTG

XMD(Mucoderm®) PROCEDURE

Xenogenous graft placed in the surgical site.

Also known as: Porcine acellular dermal matrix

MCAF+PR+XMD(Mucoderm®)

Sodium dipyrone DRUG

All participants were instructed to take 500 mg sodium dipyrone just in case of pain.

Also known as: Drug prescription

MCAF+PR+CTG; MCAF+PR+XMD(Mucoderm®)

chlorhexidine rinse DRUG

All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.

Also known as: Drug prescription

MCAF+PR+CTG; MCAF+PR+XMD(Mucoderm®)

Eligibility Criteria

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

You may qualify if:

• patients presenting three or more Miller class I or II multiple adjacent gingival recessions (recession depth ≥ 2,5 mm) in incisors, 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
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

São Paulo State University

São José dos Campos, São Paulo, 12245-000, Brazil

Location

Related Publications (4)

• Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.

  PMID: 11022782 BACKGROUND

• Tonetti MS, Cortellini P, Pellegrini G, Nieri M, Bonaccini D, Allegri M, Bouchard P, Cairo F, Conforti G, Fourmousis I, Graziani F, Guerrero A, Halben J, Malet J, Rasperini G, Topoll H, Wachtel H, Wallkamm B, Zabalegui I, Zuhr O. Xenogenic collagen matrix or autologous connective tissue graft as adjunct to coronally advanced flaps for coverage of multiple adjacent gingival recession: Randomized trial assessing non-inferiority in root coverage and superiority in oral health-related quality of life. J Clin Periodontol. 2018 Jan;45(1):78-88. doi: 10.1111/jcpe.12834. Epub 2017 Nov 21.

  PMID: 29087001 BACKGROUND

• Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.

  PMID: 7928129 BACKGROUND

• Silveira CA, Mathias IF, da Silva Neves FL, Castro Dos Santos NC, Araujo CF, Neves Jardini MA, Bresciani E, Santamaria MP. Connective Tissue Graft and Crown-Resin Composite Restoration for the Treatment of Gingival Recession Associated with Noncarious Cervical Lesions: Case Series. Int J Periodontics Restorative Dent. 2017 Jul/Aug;37(4):601-607. doi: 10.11607/prd.3044.

  PMID: 28609509 BACKGROUND

MeSH Terms

Conditions

Gingival Recession; Tooth Abrasion

Interventions

Drug Prescriptions

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Tooth Wear; Tooth Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Prescriptions; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

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: Associate professor

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 20, 2018
• Study Start: July 2, 2018
• Primary Completion: November 2, 2019
• Study Completion: August 1, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

BR (1)