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

NCT02961049 | Unknown

• 1 other identifier: CAAE - 57032016.0.0000.5152
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Wear; Tooth Wear

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Retraction and total-etch

ACTIVE COMPARATOR

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; Procedure: Enamel and dentin etched; Procedure: Wash and dry; Device: Total-etch adhesive system; Procedure: Photoactivated

No retraction and total-etch

ACTIVE COMPARATOR

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; Procedure: Wash and dry; Device: Total-etch adhesive system; Procedure: Photoactivated

Retraction and self-conditioning

ACTIVE COMPARATOR

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; Procedure: Selective enamel etched; Procedure: Wash and dry; Device: self-conditioning adhesive system; Procedure: Photoactivated

No retraction and self-conditioning

ACTIVE COMPARATOR

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; Procedure: Wash and dry; Device: self-conditioning adhesive system; Procedure: Photoactivated

Interventions

Gingival displacement PROCEDURE

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

Retraction and self-conditioning; Retraction and total-etch

Enamel and dentin etched PROCEDURE

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

No retraction and total-etch; Retraction and total-etch

Selective enamel etched PROCEDURE

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

No retraction and self-conditioning; Retraction and self-conditioning

Wash and dry PROCEDURE

Wash and dry with absorbent paper.

No retraction and self-conditioning; No retraction and total-etch; Retraction and self-conditioning; Retraction and total-etch

Total-etch adhesive system DEVICE

Two layers of pirmer/bond on enamel and dentin with a brush.

No retraction and total-etch; Retraction and total-etch

self-conditioning adhesive system DEVICE

One layer of acid/pirmer on enamel and dentin with a brush following to one layer of bond with a brush.

No retraction and self-conditioning; Retraction and self-conditioning

Photoactivated PROCEDURE

Photoactivated for 20 seconds

No retraction and self-conditioning; No retraction and total-etch; Retraction and self-conditioning; Retraction and total-etch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Federal University of Uberlandia

Uberlândia, Minas Gerais, 381440617, Brazil

RECRUITING

Related Publications (7)

• 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.

  PMID: 25312697 RESULT

• 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.

  PMID: 22296690 RESULT

• 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.

  PMID: 19796301 RESULT

• 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.

  PMID: 19228125 RESULT

• 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.

  PMID: 26158415 RESULT

• 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.

  PMID: 19830963 RESULT

• 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.

  PMID: 25091726 RESULT

MeSH Terms

Conditions

Tooth Wear

Interventions

Therapeutic Irrigation; Desiccation

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Chemistry Techniques, Analytical; Chemical Phenomena

Central Study Contacts

Paulo Vinícius Soares, DDS, MS, PHD

CONTACT

+55 34 991615642; paulovsaores@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 10, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2019
• Last Updated: November 11, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)