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

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ClinicalTrials.gov Identifier: NCT03594513
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Condition or disease Intervention/treatment Phase
Gingival Recession Tooth Abrasion Procedure: MCAF Procedure: PR Procedure: CTG Procedure: XMD(Mucoderm®) Drug: Sodium dipyrone Drug: chlorhexidine rinse Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Porcine Acellular Dermal Matrix (Mucoderm®) Versus Connective Tissue Graft in the Treatment of Multiple Adjacent Gingival Recessions Associated With Non-carious Cervical Lesion Partially Restored.
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Active Comparator: MCAF+PR+CTG
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
Periodontal surgical technique to treat gingival recessions.
Other Name: Periodontal plastic surgery

Procedure: PR
Restorative procedure to treat tooth structure loss.
Other Name: Composite resin restoration

Procedure: CTG
Autogenous graft harvested from palate placed in the surgical site.
Other Name: Connective tissue graft

Drug: Sodium dipyrone
All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
Other Name: Drug prescription

Drug: chlorhexidine rinse
All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
Other Name: Drug prescription

Experimental: MCAF+PR+XMD(Mucoderm®)
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
Periodontal surgical technique to treat gingival recessions.
Other Name: Periodontal plastic surgery

Procedure: PR
Restorative procedure to treat tooth structure loss.
Other Name: Composite resin restoration

Procedure: XMD(Mucoderm®)
Xenogenous graft placed in the surgical site.
Other Name: Porcine acellular dermal matrix

Drug: Sodium dipyrone
All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
Other Name: Drug prescription

Drug: chlorhexidine rinse
All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
Other Name: Drug prescription




Primary Outcome Measures :
  1. Percentage of defect coverage [ Time Frame: 6 months ]
    Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.


Secondary Outcome Measures :
  1. Modified root coverage esthetic score [ Time Frame: 6 months ]
    The Modified Root Coverage Esthetic Scale (MRES; Santamaria et al. 2014) will be performed by two blinded and independent examiners at the 6-month post-operative assessment. This score evaluates six variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, gingival color, and restoration/cervical lesion color.

  2. Dentine hypersensitivity [ Time Frame: 6 months ]
    Evaluation of root sensitivity with the air blow test and measurement with a visual analog scale (VAS).

  3. Patient recovery [ Time Frame: 14 days ]
    Evaluation of postsurgery sequelae, pain, and discomfort, oral function and interference with daily activities through postoperative diary previously described (Tonetti et al. 2018).

  4. Patient-centred esthetic evaluation [ Time Frame: 6 months ]
    Esthetic evaluation performed by the patient through a visual analog scale (VAS).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594513


Contacts
Contact: Mauro P Santamaria, PhD 55 16 981937777 mauro.santamaria@fosjc.unesp.br

Locations
Brazil
São Paulo State University Recruiting
São José Dos Campos, São Paulo, Brazil, 12245-000
Contact: Amanda Rossato    1239479000    amanda.rossato@hotmail.com   
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Mauro P Santamaria, PhD ICT-UNESP

Publications:
Responsible Party: Mauro Pedrine Santamaria, Associate professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03594513     History of Changes
Other Study ID Numbers: AR
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
Gingival Recession
Tooth Abrasion
Mucoderm

Additional relevant MeSH terms:
Gingival Recession
Tooth Abrasion
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
Tooth Wear
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Dipyrone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antipyretics