Evaluation of Two Resin Composites and Two Adhesives for a Novel Restorative Protocol to Treat Cervical Lesions
NCT ID: NCT03215615
Last Updated: 2019-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2016-11-30
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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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.
Periodontal surgery
Coronally advanced flap for root coverage
Total Etch adhesive
Total-etch adhesive system (two step)
Nanofilled Composite
Partial nanofilled-resin composite restoration
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.
Periodontal surgery
Coronally advanced flap for root coverage
Universal Adhesive
One-step self-etching adhesive system
Nanofilled Composite
Partial nanofilled-resin composite restoration
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.
Periodontal surgery
Coronally advanced flap for root coverage
Total Etch adhesive
Total-etch adhesive system (two step)
Micro-Hybrid Composite
Partial micro-hybrid composite restoration
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.
Periodontal surgery
Coronally advanced flap for root coverage
Universal Adhesive
One-step self-etching adhesive system
Micro-Hybrid Composite
Partial micro-hybrid composite restoration
Interventions
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Periodontal surgery
Coronally advanced flap for root coverage
Total Etch adhesive
Total-etch adhesive system (two step)
Universal Adhesive
One-step self-etching adhesive system
Nanofilled Composite
Partial nanofilled-resin composite restoration
Micro-Hybrid Composite
Partial micro-hybrid composite restoration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Universidade Estadual Paulista Júlio de Mesquita Filho
OTHER
Responsible Party
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Eduardo Bresciani
Associate Professor
Principal Investigators
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Eduardo Bresciani, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Estadual Paulista Júlio de Mesquita Filho
Locations
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UEPJMF
São José dos Campos, São Paulo, Brazil
Countries
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References
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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.
Other Identifiers
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56450116.9.0000.0077
Identifier Type: -
Identifier Source: org_study_id
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