Evaluation of Two Resin Composites and Two Adhesives for a Novel Restorative Protocol to Treat Cervical Lesions
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 24, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 13, 2019
June 1, 2019
2.6 years
November 24, 2016
June 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Aesthetics (Visual Analogue Acale - VAS)
1 year
Dentin Hypersensitivity (Visual Analogue Acale - VAS)
1 year
Study Arms (4)
Group NF + TE
ACTIVE COMPARATORNanofilled 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.
Group NF + UA
ACTIVE COMPARATORNanofilled 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.
Group MH + TE
ACTIVE COMPARATORMicro-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.
Group MH + UA
ACTIVE COMPARATORMicro-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.
Interventions
Coronally advanced flap for root coverage
Partial nanofilled-resin composite restoration
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UEPJMF
São José dos Campos, São Paulo, 12245000, Brazil
Related Publications (1)
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.
PMID: 36462038DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Bresciani, PhD
Universidade Estadual Paulista Júlio de Mesquita Filho
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 24, 2016
First Posted
July 12, 2017
Study Start
November 1, 2016
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
June 13, 2019
Record last verified: 2019-06