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

Tooth Wear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02961049
• Other study ID #: CAAE - 57032016.0.0000.5152
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2016
• Last updated: November 10, 2016
• Start date: November 2016
• Est. completion date: February 2019

Study information

• Verified date: November 2016
• Source: Federal University of Uberlandia
• Contact: Paulo Vinícius Soares, DDS, MS, PHD
• Phone: +55 34 991615642
• Email: paulovsaores[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: February 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Wear
• Tooth Wear

Intervention

Procedure:
• Gingival displacement
Gingival displacement with a gingival cord (#0, #00 or #000) with specific spatula.
• Enamel and dentin etched
Enamel and dentin etched with 35% phosphoric acid for 30 and 15 seconds, respectively.
• Selective enamel etched
Selective enamel etched with 35% phosphoric acid for 15 seconds.
• 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.
• 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

Locations

Country	Name	City	State
Brazil	Federal University of Uberlandia	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. Review. — View Citation

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 — View Citation

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 — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Soares PV, Machado AC, Zeola LF, Souza PG, Galvão 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes