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

Sponsor
Federal University of Uberlandia (Other)
Overall Status
Unknown status
CT.gov ID
NCT02961049
Collaborator
(none)
55
1
4
27
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations With Different Adhesive Systems. Randomized Clinical Trials.
Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Retraction and total-etch

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.

Procedure: Gingival displacement
Gingival displacement with a gingival cord (#0, #00 or #000) with specific spatula.

Procedure: Enamel and dentin etched
Enamel and dentin etched with 35% phosphoric acid for 30 and 15 seconds, respectively.

Procedure: Wash and dry
Wash and dry with absorbent paper.

Device: Total-etch adhesive system
Two layers of pirmer/bond on enamel and dentin with a brush.

Procedure: Photoactivated
Photoactivated for 20 seconds

Active Comparator: No retraction and total-etch

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.

Procedure: Enamel and dentin etched
Enamel and dentin etched with 35% phosphoric acid for 30 and 15 seconds, respectively.

Procedure: Wash and dry
Wash and dry with absorbent paper.

Device: Total-etch adhesive system
Two layers of pirmer/bond on enamel and dentin with a brush.

Procedure: Photoactivated
Photoactivated for 20 seconds

Active Comparator: Retraction and self-conditioning

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.

Procedure: Gingival displacement
Gingival displacement with a gingival cord (#0, #00 or #000) with specific spatula.

Procedure: Selective enamel etched
Selective enamel etched with 35% phosphoric acid for 15 seconds.

Procedure: Wash and dry
Wash and dry with absorbent paper.

Device: self-conditioning adhesive system
One layer of acid/pirmer on enamel and dentin with a brush following to one layer of bond with a brush.

Procedure: Photoactivated
Photoactivated for 20 seconds

Active Comparator: No retraction and self-conditioning

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.

Procedure: Selective enamel etched
Selective enamel etched with 35% phosphoric acid for 15 seconds.

Procedure: Wash and dry
Wash and dry with absorbent paper.

Device: self-conditioning adhesive system
One layer of acid/pirmer on enamel and dentin with a brush following to one layer of bond with a brush.

Procedure: Photoactivated
Photoactivated for 20 seconds

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federal University of Uberlandia Uberlandia Minas Gerais Brazil 381440617

Sponsors and Collaborators

  • Federal University of Uberlandia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PAULO VINICIUS SOARES, Professor, Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT02961049
Other Study ID Numbers:
  • CAAE - 57032016.0.0000.5152
First Posted:
Nov 10, 2016
Last Update Posted:
Nov 11, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 11, 2016