Clinical Performance of Different Adhesive Strategies With a Universal System in Sclerosed Dentin in NCCL: A Double-blind Randomized Clinical Trial.

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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Two hundred restorations will be performed in NCCL of volunteers of both genders, by a single operator, using the Single Bond Universal(3M ESPE) adhesive system. The restorations will be randomly allocated into 4 groups (n-50): D-SE (absence of dentinal sclerosis and self-etching protocol); D-SELETIVE (absence of dentinal sclerosis and selective enamel etching protocol); SD-SE (sclerotic dentin and self-etching protocol); SD-SELETIVE (sclerotic dentin and selective enamel etching protocol). The randomization process within subject was performed by computer-generated tables by a staff member not involved in the research protocol. Details of the allocated group were recorded on cards contained in sequentially numbered, opaque, sealed envelopes. These were prepared by a staff member who was not involved in any of the phases of the clinical trial. The allocation assignment was revealed by opening the envelope on the day of the restorative procedure.The operator was not blinded to group assignment when administering.

The evaluations of the clinical performance of the restorations will be carried out by two previously calibrated examiners, adopting the criteria of the United States Public Health Service (USPHS) for the variables retention, marginal adaptation, marginal staining and postoperative sensitivity . The intragroup statistical analysis will be performed using the McNemar test for the variables retention and postoperative sensitivity; and by Wilcoxon for adaptation and marginal staining. To compare the clinical performance inter groups in the different assessment intervals, Fisher's exact test (retention and postoperative sensitivity) and Kruskal-Wallis (adaptation and marginal staining) will be used.

Conditions

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Sclerotic Dentine Non Carious Cervical Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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D-SE

Absence of dentinal sclerosis and self-etching adhesive protocol

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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-SELETIVE

Absence of dentinal sclerosis and selective enamel etching adhesive protocol

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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.

SD-SE

Sclerotic dentin and self-etching adhesive protocol

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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-SELETIVE

Sclerotic dentin and selective enamel etching adhesive protocol

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Interventions

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

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.

Intervention Type PROCEDURE

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

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.

Intervention Type PROCEDURE

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

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.

Intervention Type PROCEDURE

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

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes