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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group NF + TE | Active Comparator | 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. |
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| Group NF + UA | Active Comparator | 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. |
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| Group MH + TE | Active Comparator | 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. |
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| Group MH + UA | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal surgery | Procedure | Coronally advanced flap for root coverage |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetics (Visual Analogue Acale - VAS) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Bresciani, PhD | Universidade Estadual Paulista Júlio de Mesquita Filho | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UEPJMF | São José dos Campos | São Paulo | 12245000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36462038 | Derived | Mathias-Santamaria IF, Santamaria MP, Silveira CA, Martinho FC, de Melo MAS, De Marco AC, Augusto MG, de Andrade GS, Roulet JF, Bresciani E. Evaluation of a novel restorative protocol to treat non-carious cervical lesion associated with gingival recession: a 2-year follow-up randomized clinical trial. Clin Oral Investig. 2023 Apr;27(4):1781-1792. doi: 10.1007/s00784-022-04806-1. Epub 2022 Dec 3. |
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| Total Etch adhesive | Procedure | Total-etch adhesive system (two step) |
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| Universal Adhesive | Procedure | One-step self-etching adhesive system |
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| Nanofilled Composite | Procedure | Partial nanofilled-resin composite restoration |
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| Micro-Hybrid Composite | Procedure | Partial micro-hybrid composite restoration |
|
The Dentin Hypersensitivity will be evaluated by patients´ point of view using the VAS scale
| 1 year |
| ID | Term |
|---|---|
| D014072 | Tooth Abrasion |
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D057085 | Tooth Wear |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D055093 | Periodontal Atrophy |
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