NCT05211908

Brief Summary

The aim of this randomized, prospective, parallel, double-blind clinical trial will be to evaluate the clinical performance of restorations performed in non-carious cervical lesions (NCCL) using a soft ph universal adhesive system, varying the adhesive strategy (self-etching vs. selective etching of the enamel) and the sclerosis characteristics of the dentinal substrate over 24 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

January 13, 2022

Last Update Submit

May 17, 2022

Conditions

Sclerotic DentineNon Carious Cervical Lesion

Keywords

adhesivesdental bonding

Outcome Measures

Primary Outcomes (2)

  • Retention

    The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure.

    1 year

  • Retention

    The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure.

    2 years

Secondary Outcomes (4)

  • Marginal adaptation

    1 year

  • Marginal adaptation

    2 years

  • Marginal staining

    1 Year

  • Marginal staining

    2 Years

Study Arms (4)

D-SE

EXPERIMENTAL

Absence of dentinal sclerosis and self-etching adhesive protocol

Procedure: Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentin

D-SELETIVE

ACTIVE COMPARATOR

Absence of dentinal sclerosis and selective enamel etching adhesive protocol

Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentin

SD-SE

EXPERIMENTAL

Sclerotic dentin and self-etching adhesive protocol

Procedure: Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentin

SD-SELETIVE

EXPERIMENTAL

Sclerotic dentin and selective enamel etching adhesive protocol

Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentin

Interventions

Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentinPROCEDURE

The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the D-SE group, the universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.

D-SE
Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentinPROCEDURE

The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the D-SELETIVE group a 37% phosphoric acid will be applied only at the enamel margin for 15s, then rinsed with water for 20s, and slightly dry. The universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.

D-SELETIVE
Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentinPROCEDURE

The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the SD-SE group, the universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.

SD-SE
Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentinPROCEDURE

The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the SD-SELETIVE group a 37% phosphoric acid will be applied only at the enamel margin for 15s, then rinsed with water for 20s, and slightly dry. The universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.

SD-SELETIVE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good general health status
  • Good oral hygiene
  • Absence of periodontal disease
  • Minimum of 20 teeth in occlusion
  • Presence at least one (01) non-carious cervical lesion in a tooth with pulp vitality.
  • Non-carious cervical lesion greater than 1mm in depth.
  • Non-carious cervical lesion involving enamel and dentin.

You may not qualify if:

  • Non- carious cervical lesion cavo surface margin involving more than 50% of the enamel.
  • NCCL in crack teeth.
  • Absence of opposing teeth and/or adjacent to the lesion.
  • Presence of occlusal trauma in the NCCL tooth
  • Presence of orthodontic appliance or removable partial denture with retention in the tooth where the lesion is located
  • Patients that underwent tooth whitening procedures within a period of less than 14 days from the date of restoration
  • Patients with high risk of caries (presence of three or more active caries lesions)
  • Xerostomia
  • Bruxism
  • Pregnant women
  • Patients who do not accept the study conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Pará

Belém, Pará, Brazil

RECRUITING

MeSH Terms

Conditions

Dentin, Secondary

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Cecy M Silva, PhD

    Universidade Federal do Pará

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecy M Silva, PhD

CONTACT

(91)3201-7563cecymsilva@gmail.com

Thaís AF Barros, PhD student

CONTACT

(91) 98141-8583thaisa_fig@hotmail.com

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
Clinical professor

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 27, 2022

Study Start

July 27, 2021

Primary Completion

March 30, 2022

Study Completion

December 30, 2023

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)