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

Primary Purpose

Dental Abrasion, Gingival Recession, Composite Resins

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Periodontal surgery
Total Etch adhesive
Universal Adhesive
Nanofilled Composite
Micro-Hybrid Composite
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Abrasion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UEPJMF

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group NF + TE

Group NF + UA

Group MH + TE

Group MH + UA

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Modified United States Public Health Service (USPHS) criteria
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

Secondary Outcome Measures

Aesthetics (Visual Analogue Acale - VAS)
The esthetics of the treatment will be evaluated by patients´ point of view using the VAS scale
Dentin Hypersensitivity (Visual Analogue Acale - VAS)
The Dentin Hypersensitivity will be evaluated by patients´ point of view using the VAS scale

Full Information

First Posted
November 24, 2016
Last Updated
June 12, 2019
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT03215615
Brief Title
Evaluation of Two Resin Composites and Two Adhesives for a Novel Restorative Protocol to Treat Cervical Lesions
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Abrasion, Gingival Recession, Composite Resins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group NF + TE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group NF + UA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group MH + TE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group MH + UA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Periodontal surgery
Intervention Description
Coronally advanced flap for root coverage
Intervention Type
Procedure
Intervention Name(s)
Total Etch adhesive
Intervention Description
Total-etch adhesive system (two step)
Intervention Type
Procedure
Intervention Name(s)
Universal Adhesive
Intervention Description
One-step self-etching adhesive system
Intervention Type
Procedure
Intervention Name(s)
Nanofilled Composite
Intervention Description
Partial nanofilled-resin composite restoration
Intervention Type
Procedure
Intervention Name(s)
Micro-Hybrid Composite
Intervention Description
Partial micro-hybrid composite restoration
Primary Outcome Measure Information:
Title
Modified United States Public Health Service (USPHS) criteria
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Aesthetics (Visual Analogue Acale - VAS)
Description
The esthetics of the treatment will be evaluated by patients´ point of view using the VAS scale
Time Frame
1 year
Title
Dentin Hypersensitivity (Visual Analogue Acale - VAS)
Description
The Dentin Hypersensitivity will be evaluated by patients´ point of view using the VAS scale
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Bresciani, PhD
Organizational Affiliation
Universidade Estadual Paulista Júlio de Mesquita Filho
Official's Role
Principal Investigator
Facility Information:
Facility Name
UEPJMF
City
Sao Jose dos Campos
State/Province
Sao Paulo
ZIP/Postal Code
12245000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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