Evaluation of Two Resin Composites and Two Adhesives for a Novel Restorative Protocol to Treat Cervical Lesions
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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: Universal Adhesive
One-step self-etching adhesive system
Procedure: Nanofilled Composite
Partial nanofilled-resin composite restoration
|
| 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
|
Outcome Measures
Primary Outcome Measures
- Modified United States Public Health Service (USPHS) criteria [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
Secondary Outcome Measures
- Aesthetics (Visual Analogue Acale - VAS) [1 year]
The esthetics of the treatment will be evaluated by patients´ point of view using the VAS scale
- Dentin Hypersensitivity (Visual Analogue Acale - VAS) [1 year]
The Dentin Hypersensitivity will be evaluated by patients´ point of view using the VAS scale
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UEPJMF | Sao Jose dos Campos | Sao Paulo | Brazil | 12245000 |
Sponsors and Collaborators
- Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
- Principal Investigator: Eduardo Bresciani, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 56450116.9.0000.0077