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

NCT ID: NCT02961049

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Wear Tooth Wear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Gingival displacement

Intervention Type PROCEDURE

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

Enamel and dentin etched

Intervention Type PROCEDURE

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

Wash and dry

Intervention Type PROCEDURE

Wash and dry with absorbent paper.

Total-etch adhesive system

Intervention Type DEVICE

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

Photoactivated

Intervention Type PROCEDURE

Photoactivated for 20 seconds

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.

Group Type ACTIVE_COMPARATOR

Enamel and dentin etched

Intervention Type PROCEDURE

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

Wash and dry

Intervention Type PROCEDURE

Wash and dry with absorbent paper.

Total-etch adhesive system

Intervention Type DEVICE

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

Photoactivated

Intervention Type PROCEDURE

Photoactivated for 20 seconds

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.

Group Type ACTIVE_COMPARATOR

Gingival displacement

Intervention Type PROCEDURE

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

Selective enamel etched

Intervention Type PROCEDURE

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

Wash and dry

Intervention Type PROCEDURE

Wash and dry with absorbent paper.

self-conditioning adhesive system

Intervention Type DEVICE

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

Photoactivated

Intervention Type PROCEDURE

Photoactivated for 20 seconds

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.

Group Type ACTIVE_COMPARATOR

Selective enamel etched

Intervention Type PROCEDURE

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

Wash and dry

Intervention Type PROCEDURE

Wash and dry with absorbent paper.

self-conditioning adhesive system

Intervention Type DEVICE

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

Photoactivated

Intervention Type PROCEDURE

Photoactivated for 20 seconds

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gingival displacement

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

Intervention Type PROCEDURE

Enamel and dentin etched

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

Intervention Type PROCEDURE

Selective enamel etched

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

Intervention Type PROCEDURE

Wash and dry

Wash and dry with absorbent paper.

Intervention Type PROCEDURE

Total-etch adhesive system

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

Intervention Type 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.

Intervention Type DEVICE

Photoactivated

Photoactivated for 20 seconds

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

PAULO VINICIUS SOARES

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paulo VinĂ­cius Soares, DDS, MS, PHD

Role: CONTACT

Phone: +55 34 991615642

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Paulo V Soares, DDS, MS, PHD

Role: primary

Alexandre C Machado, DDS, MS

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25312697 (View on PubMed)

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.

Reference Type RESULT
PMID: 22296690 (View on PubMed)

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.

Reference Type RESULT
PMID: 19796301 (View on PubMed)

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.

Reference Type RESULT
PMID: 19228125 (View on PubMed)

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.

Reference Type RESULT
PMID: 26158415 (View on PubMed)

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.

Reference Type RESULT
PMID: 19830963 (View on PubMed)

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.

Reference Type RESULT
PMID: 25091726 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAAE - 57032016.0.0000.5152

Identifier Type: -

Identifier Source: org_study_id