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

Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations With Different Adhesive Systems. Randomized Clinical Trials.

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paulo Vinícius Soares, DDS, MS, PHD; Phone Number: +55 34 991615642; Email: paulovsaores@yahoo.com.br

Study Locations

• Brazil
  • Minas Gerais
    • Uberlandia, Minas Gerais, Brazil, 381440617
      • Recruiting
      • Federal University of Uberlandia
      • Contact: Paulo V Soares, DDS, MS, PHD; Phone Number: +55 34 991615642; Email: paulovsoares@yahoo.com.br
      • Contact: Alexandre C Machado, DDS, MS; Phone Number: +55 34 99133 5399; Email: alexandrecoelhomachado@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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: Wash and dry; Wash and dry with absorbent paper.; Procedure: Photoactivated; Photoactivated for 20 seconds; Procedure: Selective enamel etched; Selective enamel etched with 35% phosphoric acid for 15 seconds.; 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.
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: Wash and dry; Wash and dry with absorbent paper.; Procedure: Photoactivated; Photoactivated for 20 seconds; Procedure: Selective enamel etched; Selective enamel etched with 35% phosphoric acid for 15 seconds.; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia

Publications and helpful links

General Publications

• Soares PV, Machado AC, Zeola LF, Souza PG, Galvao AM, Montes TC, Pereira AG, Reis BR, Coleman TA, Grippo JO. Loading and composite restoration assessment of various non-carious cervical lesions morphologies - 3D finite element analysis. Aust Dent J. 2015 Sep;60(3):309-16. doi: 10.1111/adj.12233.
• Grippo JO, Simring M, Coleman TA. Abfraction, abrasion, biocorrosion, and the enigma of noncarious cervical lesions: a 20-year perspective. J Esthet Restor Dent. 2012 Feb;24(1):10-23. doi: 10.1111/j.1708-8240.2011.00487.x. Epub 2011 Nov 17.
• Ritter AV, Grippo JO, Coleman TA, Morgan ME. Prevalence of carious and non-carious cervical lesions in archaeological populations from North America and Europe. J Esthet Restor Dent. 2009;21(5):324-34. doi: 10.1111/j.1708-8240.2009.00285.x.
• Michael JA, Townsend GC, Greenwood LF, Kaidonis JA. Abfraction: separating fact from fiction. Aust Dent J. 2009 Mar;54(1):2-8. doi: 10.1111/j.1834-7819.2008.01080.x.
• Loguercio AD, Luque-Martinez I, Lisboa AH, Higashi C, Queiroz VA, Rego RO, Reis A. Influence of Isolation Method of the Operative Field on Gingival Damage, Patients' Preference, and Restoration Retention in Noncarious Cervical Lesions. Oper Dent. 2015 Nov-Dec;40(6):581-93. doi: 10.2341/14-089-C. Epub 2015 Jul 9.
• Kim SY, Lee KW, Seong SR, Lee MA, Lee IB, Son HH, Kim HY, Oh MH, Cho BH. Two-year clinical effectiveness of adhesives and retention form on resin composite restorations of non-carious cervical lesions. Oper Dent. 2009 Sep-Oct;34(5):507-15. doi: 10.2341/08-006C.
• Peumans M, De Munck J, Mine A, Van Meerbeek B. Clinical effectiveness of contemporary adhesives for the restoration of non-carious cervical lesions. A systematic review. Dent Mater. 2014 Oct;30(10):1089-103. doi: 10.1016/j.dental.2014.07.007. Epub 2014 Aug 3.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 10, 2016

Study Record Updates

• Last Update Posted (Estimate): November 11, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear
• Other Study ID Numbers: CAAE - 57032016.0.0000.5152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No