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

Not Applicable

Completed

• Conditions: Gingival Recession; Composite Resins; Dental Abrasion
• Interventions: Procedure: Periodontal surgery; Procedure: Total Etch adhesive; Procedure: Universal Adhesive; Procedure: Micro-Hybrid Composite; Procedure: Nanofilled Composite

• Registration Number: NCT03215615
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Status Verified: 2019-06
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group NF + TE	Total Etch adhesive	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.
Group NF + UA	Universal Adhesive	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.
Group MH + TE	Periodontal surgery	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.
Group NF + UA	Periodontal surgery	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.
Group NF + TE	Periodontal surgery	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.
Group MH + UA	Universal Adhesive	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.
Group MH + UA	Micro-Hybrid Composite	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.
Group MH + TE	Total Etch adhesive	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.
Group MH + TE	Micro-Hybrid Composite	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.
Group NF + TE	Nanofilled Composite	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.
Group MH + UA	Periodontal surgery	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.
Group NF + UA	Nanofilled Composite	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Dentin Hypersensitivity (Visual Analogue Acale - VAS)	1 year	The Dentin Hypersensitivity will be evaluated by patients´ point of view using the VAS scale
Aesthetics (Visual Analogue Acale - VAS)	1 year	The esthetics of the treatment will be evaluated by patients´ point of view using the VAS scale

Trial Locations

Locations (1)

UEPJMF; 🇧🇷 Sao Jose dos Campos, Sao Paulo, Brazil