Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations.

Not Applicable

• Conditions: Tooth Wear; Dental Wear
• Interventions: Procedure: Gingival displacement; Procedure: Enamel and dentin etched; Procedure: Selective enamel etched; Procedure: Wash and dry; Device: Total-etch adhesive system; Device: self-conditioning adhesive system; Procedure: Photoactivated

• Registration Number: NCT02961049
• Lead Sponsor: Federal University of Uberlandia

Brief Summary

The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The presence of gingival displacement with a retraction cord (yes or no) and the category of adhesive system (etch-and-rise and self-etching) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Detailed Description

Cervical wear is classified as a noncarious cervical lesion (NCCL), which is a pathological process characterized by loss of dental hard tissues near the cementoenamel junction (CEJ). The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The presence of gingival displacement with a retraction cord and the category of adhesive system will be evaluated. Two hundred and twenty teeth, with NCCL of depth greater than 1.5mm, of 55 healthy patients of both sexes will be select. The teeth will be randomly divided into 4 different groups according to the gingival displacement with retraction cord (yes or no) and adhesive system category (etch-and-rise and self-etching). Data will be collected, tabulated and submitted to statistical analysis.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-10
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-11
• Primary Completion: 2017-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Healthy volunteers; both genres; presence of at least four non carious cervical lesions of similar dimensions in the same arc and opposite quadrants; good oral hygiene.

Exclusion Criteria

• Presence of cavities, cracks or enamel fractures; extensive or unsatisfactory restorations; recent restorations involving the labial surface; dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retraction and total-etch	Gingival displacement	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
Retraction and self-conditioning	Selective enamel etched	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
Retraction and total-etch	Photoactivated	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
No retraction and total-etch	Enamel and dentin etched	Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
Retraction and total-etch	Enamel and dentin etched	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
Retraction and total-etch	Wash and dry	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
Retraction and total-etch	Total-etch adhesive system	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
No retraction and total-etch	Wash and dry	Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
No retraction and total-etch	Total-etch adhesive system	Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
Retraction and self-conditioning	Gingival displacement	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
No retraction and self-conditioning	Selective enamel etched	Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
No retraction and self-conditioning	Wash and dry	Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
No retraction and total-etch	Photoactivated	Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
Retraction and self-conditioning	Photoactivated	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
Retraction and self-conditioning	self-conditioning adhesive system	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
No retraction and self-conditioning	self-conditioning adhesive system	Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
No retraction and self-conditioning	Photoactivated	Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
Retraction and self-conditioning	Wash and dry	Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.

Primary Outcome Measures

Name	Time	Method
Success rate of noncarious cervical lesions restorations according to the World Dental Federation criterion	36 mounths	Evaluate the success rate of NCCL restoration with a 36 mounths follow up

Trial Locations

Locations (1)

Federal University of Uberlandia; 🇧🇷 Uberlandia, Minas Gerais, Brazil