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

Primary Purpose

Dental Wear, Tooth Wear

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Gingival displacement
Enamel and dentin etched
Selective enamel etched
Wash and dry
Total-etch adhesive system
self-conditioning adhesive system
Photoactivated
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Wear

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of UberlandiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Retraction and total-etch

No retraction and total-etch

Retraction and self-conditioning

No retraction and self-conditioning

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 8, 2016
Last Updated
November 10, 2016
Sponsor
Federal University of Uberlandia
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1. Study Identification

Unique Protocol Identification Number
NCT02961049
Brief Title
Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations.
Official Title
Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations With Different Adhesive Systems. Randomized Clinical Trials.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Wear, Tooth Wear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retraction and total-etch
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No retraction and total-etch
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Retraction and self-conditioning
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No retraction and self-conditioning
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gingival displacement
Intervention Description
Gingival displacement with a gingival cord (#0, #00 or #000) with specific spatula.
Intervention Type
Procedure
Intervention Name(s)
Enamel and dentin etched
Intervention Description
Enamel and dentin etched with 35% phosphoric acid for 30 and 15 seconds, respectively.
Intervention Type
Procedure
Intervention Name(s)
Selective enamel etched
Intervention Description
Selective enamel etched with 35% phosphoric acid for 15 seconds.
Intervention Type
Procedure
Intervention Name(s)
Wash and dry
Intervention Description
Wash and dry with absorbent paper.
Intervention Type
Device
Intervention Name(s)
Total-etch adhesive system
Intervention Description
Two layers of pirmer/bond on enamel and dentin with a brush.
Intervention Type
Device
Intervention Name(s)
self-conditioning adhesive system
Intervention Description
One layer of acid/pirmer on enamel and dentin with a brush following to one layer of bond with a brush.
Intervention Type
Procedure
Intervention Name(s)
Photoactivated
Intervention Description
Photoactivated for 20 seconds
Primary Outcome Measure Information:
Title
Success rate of noncarious cervical lesions restorations according to the World Dental Federation criterion
Description
Evaluate the success rate of NCCL restoration with a 36 mounths follow up
Time Frame
36 mounths

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulo Vinícius Soares, DDS, MS, PHD
Phone
+55 34 991615642
Email
paulovsaores@yahoo.com.br
Facility Information:
Facility Name
Federal University of Uberlandia
City
Uberlandia
State/Province
Minas Gerais
ZIP/Postal Code
381440617
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo V Soares, DDS, MS, PHD
Phone
+55 34 991615642
Email
paulovsoares@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Alexandre C Machado, DDS, MS
Phone
+55 34 99133 5399
Email
alexandrecoelhomachado@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25312697
Citation
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.
Results Reference
result
PubMed Identifier
22296690
Citation
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.
Results Reference
result
PubMed Identifier
19796301
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.
Results Reference
result
PubMed Identifier
19228125
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.
Results Reference
result
PubMed Identifier
26158415
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-Dec;40(6):581-93. doi: 10.2341/14-089-C. Epub 2015 Jul 9.
Results Reference
result
PubMed Identifier
19830963
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: 10.2341/08-006C.
Results Reference
result
PubMed Identifier
25091726
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. Epub 2014 Aug 3.
Results Reference
result

Learn more about this trial

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

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