Evaluation of Two Resin Composites and Two Adhesives for a Novel Restorative Protocol to Treat Cervical Lesions

June 12, 2019 updated by: Eduardo Bresciani, Universidade Estadual Paulista Júlio de Mesquita Filho

Evaluation of Two Resin Composites and Two Adhesives for a Novel Surgical-restorative Protocol for the Treatment of Non-carious Cervical Lesions Associated With Gingival Recession: a Randomized Controlled Clinical Trial

Non-carious cervical lesion is frequently associated with gingival recession, resulting in a combined lesion that has a different treatment prognosis when the two lesions appear alone. The literature presents few studies that propose a multidisciplinary approach (restorative and root coverage surgery procedures) to optimize the treatment of this combined lesion. The previously proposed approaches and materials have limitations and an optimal clinical protocol has not been established yet. Thus the aim of this study is to evaluate a novel multidisciplinary protocol with two resin composites and two different adhesive systems through a randomized clinical trial and laboratory studies. 120 combined lesions will be randomly assigned to one of the following groups: NP + TE (n = 30) - Partial restoration of cervical lesions with nanofilled composite and total-etch adhesive system and periodontal surgery for root coverage, NP + UA (n = 30) - partial restoration of cervical lesions with nanofilled composite and self-etching adhesive system and periodontal surgery for root coverage, MH + TE (n = 30) - partial restoration of cervical lesions with microhybrid composite and total-etch adhesive system and periodontal surgery for root coverage, MH + UA (n = 30) - partial restoration of cervical lesions with microhybrid composite and self-etching adhesive system and periodontal surgery for root coverage. Restorations will be assessed using the USPHS criteria after one week, six months and twelve months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Sao Jose dos Campos, Sao Paulo, Brazil, 12245000
        • UEPJMF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals presenting one or more combined defect, i.e. a NCCL classified as B+ (Pini-Prato et al., 2010): presenting more than 1mm in depth, affecting dental crown and root associated with Miller's class I or II gingival recession in canines or premolars with pulp vitality;
  • Healthy patients (systemically and periodontally), 18 years old, with at least 20 teeth in occlusion;
  • Plaque index ≤ 20% (Ainamo & Bay, 1975);
  • NCCL cavo-surface margin without involvement of more than 50% of enamel;
  • In tooth included in the study and the adjacent elements of the following must be observed: probing depth less than 3 mm; do not show bleeding on probing (periodontal health) and no insertion loss in the proximal and palatal areas; Provide formal consent to participate in research, after the explanation of the risks and benefits by an individual not involved in it (Resolution #196 October 1996 and the Code of Dental Professional Ethics - C.F.O. - 179/93).

Exclusion Criteria:

  • NCCL previously restored;
  • Presence of caries;
  • Patients with periodontitis;
  • Patients with bruxism or teeth clenching;
  • Patients with orthodontic treatment in progress;
  • Pregnant patients or smokers;
  • Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, diabetes and others), which contraindicate the surgical procedure; Previous periodontal surgery in the area of interest of the present study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group NF + TE
Nanofilled Composite - Filtek Z350 XT® - 3M ESPE (NF) + Total Etch adhesive - Adper Single Bond 2® - 3M ESPE (TE) adhesive: combined lesions will be treated with partial restoration with nanofilled resin composite and total-etch adhesive system (two step). Subsequently, periodontal surgery will be performed for root coverage.
Procedure: Periodontal surgery
Coronally advanced flap for root coverage
Procedure: Total Etch adhesive
Total-etch adhesive system (two step)
Procedure: Nanofilled Composite
Partial nanofilled-resin composite restoration
ACTIVE_COMPARATOR: Group NF + UA
Nanofilled Composite - Filtek Z350 XT® - 3M ESPE (NF) + Universal Adhesive - Single Bond Universal® - 3M ESPE (UA): combined lesions will be treated with partial restoration with nanofilled resin composite and one-step self-etching adhesive system. Subsequently, periodontal surgery will be performed for root coverage.
Procedure: Periodontal surgery
Coronally advanced flap for root coverage
Procedure: Nanofilled Composite
Partial nanofilled-resin composite restoration
Procedure: Universal Adhesive
One-step self-etching adhesive system
ACTIVE_COMPARATOR: Group MH + TE
Micro-Hybrid Composite - Charisma Classic® - Heraeus Kulzer (MH) + Total Etch adhesive - Adper Single Bond 2® - 3M ESPE (TE) adhesive: combined lesions will be treated with partial restoration with micro-hybrid resin composite and total-etch adhesive system (two step). Subsequently, periodontal surgery will be performed for root coverage.
Procedure: Periodontal surgery
Coronally advanced flap for root coverage
Procedure: Total Etch adhesive
Total-etch adhesive system (two step)
Procedure: Micro-Hybrid Composite
Partial micro-hybrid composite restoration
ACTIVE_COMPARATOR: Group MH + UA
Micro-Hybrid Composite - Charisma Classic® - Heraeus Kulzer (MH) + Universal Adhesive - Single Bond Universal® - 3M ESPE (UA): combined lesions will be treated with partial restoration with micro-hybrid resin composite and one-step self-etching adhesive system. Subsequently, periodontal surgery will be performed for root coverage.
Procedure: Periodontal surgery
Coronally advanced flap for root coverage
Procedure: Universal Adhesive
One-step self-etching adhesive system
Procedure: Micro-Hybrid Composite
Partial micro-hybrid composite restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified United States Public Health Service (USPHS) criteria
Time Frame: 1 year
USPHS criteria is based on the following ratings: Color compatibility, retention, marginal adaptation, anatomic form, surface texture, marginal discoloration, sensibility pre-operative and postoperative and the presence of secondary caries
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetics (Visual Analogue Acale - VAS)
Time Frame: 1 year
The esthetics of the treatment will be evaluated by patients´ point of view using the VAS scale
1 year
Dentin Hypersensitivity (Visual Analogue Acale - VAS)
Time Frame: 1 year
The Dentin Hypersensitivity will be evaluated by patients´ point of view using the VAS scale
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

  • Principal Investigator: Eduardo Bresciani, PhD, Universidade Estadual Paulista Julio de Mesquita Filho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

July 10, 2017

First Posted (ACTUAL)

July 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56450116.9.0000.0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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