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

Gingival Recession Clinical Trial

Official title:

Evaluation of Two Resin Composites and Two Adhesives for a Novel Surgical-restorative Protocol for the Treatment of Non-carious Cervical Lesions Associated With Gingival Recession: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215615
• Other study ID #: 56450116.9.0000.0077
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: June 2019

Study information

• Verified date: June 2019
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Composite Resins
• Dental Abrasion
• Gingival Recession
• Tooth Abrasion

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Brazil	UEPJMF	Sao Jose dos Campos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Aesthetics (Visual Analogue Acale - VAS)	The esthetics of the treatment will be evaluated by patients´ point of view using the VAS scale	1 year
Secondary	Dentin Hypersensitivity (Visual Analogue Acale - VAS)	The Dentin Hypersensitivity will be evaluated by patients´ point of view using the VAS scale	1 year