Influence of Surface Sealants on the Quality of Posterior Restorations With Bulk Fill Composites

NCT ID: NCT03924830

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2026-09-30

Brief Summary

Treatment clinical trial, randomized, controled, parallel, double-blinded, with three groups, that aims to evaluate if there is some advantage in applying surface sealants (Biscover, Bisco, USA or Permaseal, Ultradent, USA) associated with a Bulk Fill Composite (Tetric N-Ceram Bulk Fill, Ivoclar Vivadent,Liechtenstein). Volunteers will be selected and recruited,following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. 53 enrolled patients will receive 159 Class I or Class II dental restorations, made in three different ways, one from each experimental group (no sealant, or one of the evaluated surface sealants). Occlusal or Proximo-occlusal lesions will receive the selected treatments separated by groups. Group Bulk without surface sealant (BNS), Group Bulk and Biscover (BSB), and Group Bulk and Permaseal (BSP). Immediate post-operative tooth sensitivity will be evaluated after one week. Restorations will be evaluated every 6 months for pain assessment, shape, fractures, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.

Detailed Description

This is a Treatment clinical trial, randomized, controlled, parallel, double-blinded, with three groups, that aims to evaluate if there is some advantage in applying surface sealants (Biscover, Bisco, USA or Permaseal, Ultradent, USA) associated with a Bulk Fill Composite (Tetric N-Ceram Bulk Fill, Ivoclar Vivadent, Liechtenstein). Volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. All 53 enrolled patients will receive 159 Class I or Class II dental restorations, made in three different ways, one from each experimental group, using the same self-etching adhesive system, under the restorations that will use the same bulk fill composite. All patients must have at only 20 teeth in function, must have at only 3 carious lesion in occlusal or proximo-occlusal face in posterior teeth or old restorations in the same faces, with problems, that need to be changed. Those lesions must be more than 2 mm deep, should have exposed dentin, and must have at only 50% of margins in enamel. Teeth should not present periodontal mobility. Firstly, the patient will be anesthetized locally with 3% Mepivacaine solution, followed by prophylaxis with pumice powder and water. All cavities will be washed and dried after these procedures for optimal selection of color, using a color scale. Then, the rubber dam isolation of the teeth to be restored will be held. Occlusal or Proximo-occlusal lesions will receive the restorative procedurs in 3 different protocols separated by groups. Group Bulk without surface sealant (BNS): the adhesive system will be used in 53 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Tetric N-Ceram Bulk fill composite will be used in increments of 4 mm, using the bulk restoration technique, and photoactivated for 40 seconds; Group Bulk and Biscover (BSB): adhesive and restorative procedures will be performed as described in group BNS in 53 teeth. After the restorations are concluded, Biscover surface sealant will be applied according to the manufacturer's instructions; Group Bulk and Permaseal (BSP): adhesive and restorative procedures will be performed as described in group BNS in 53 teeth. After the restorations are concluded, Permaseal surface sealant will be applied according to the manufacturer's instructions. Immediate post-operative tooth sensitivity will be evaluated after one week. Restorations will be evaluated every 6 months for pain assessment, shape, fractures, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.

Conditions

Dental Restoration Failure of Marginal Integrity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bulk without Surface Sealant

53 teeth will receive restorations using Bulk fill restoration without surface sealant

Group Type: ACTIVE_COMPARATOR

Bulk without surface sealant

Intervention Type: PROCEDURE

Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds.

Bulk with Biscover

53 teeth will receive restorations using Bulk fill restoration with Biscover surface sealant

Group Type: EXPERIMENTAL

Bulk with Biscover

Intervention Type: PROCEDURE

Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, biscover surface sealant will be applied according to the manufacturer's instructions.

Bulk with Permaseal

53 teeth will receive restorations using Bulk fill restoration with Permaseal surface sealant

Group Type: EXPERIMENTAL

Bulk with Permaseal

Intervention Type: PROCEDURE

Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, Permaseal surface sealant will be applied according to the manufacturer's instructions.

Interventions

Bulk without surface sealant

Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds.

Intervention Type: PROCEDURE

Bulk with Biscover

Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, biscover surface sealant will be applied according to the manufacturer's instructions.

Intervention Type: PROCEDURE

Bulk with Permaseal

Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, Permaseal surface sealant will be applied according to the manufacturer's instructions.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All patients must have at only 20 teeth in function, must have at only 3 carious occlusal or proximo-occlusal lesions, or old restorations that need to be changed, in different teeth. Those lesions must be more than 2 mm deep, should have exposed dentin, and must have at only 50% of margins in enamel. Teeth should not present periodontal mobility.

Exclusion Criteria

• Volunteers with periodontal disease; with gingival bleeding; use of anti-inflammatory drugs in the last 30 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal Fluminense

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MARCOS O BARCELEIRO, DDS, PHD

Role: STUDY_DIRECTOR

Universidade Federal Fluminense

Locations

Universidade Federal Fluminense - School of Dentistry

Nova Friburgo, Rio de Janeiro, Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25625133 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 26800647 (View on PubMed)

Costa T, Rezende M, Sakamoto A, Bittencourt B, Dalzochio P, Loguercio AD, Reis A. Influence of Adhesive Type and Placement Technique on Postoperative Sensitivity in Posterior Composite Restorations. Oper Dent. 2017 Mar/Apr;42(2):143-154. doi: 10.2341/16-010-C. Epub 2016 Nov 28.

Reference Type: BACKGROUND

PMID: 27892839 (View on PubMed)

Calazans FS, Ferreira TMJ, Naupari-Villasante R, Mendonca RP, Ornellas G, Albuquerque EG, Tardem C, de Miranda MS, Barceleiro MO, Loguercio AD. Influence of surface sealants on the quality of posterior restorations with bulk-fill composites: A 4-year randomized clinical trial. Dent Mater. 2024 Mar;40(3):466-476. doi: 10.1016/j.dental.2023.12.011. Epub 2023 Dec 22.

Reference Type: DERIVED

PMID: 38142146 (View on PubMed)

Other Identifiers

UFFBULKSEAL2018

Identifier Type: -

Identifier Source: org_study_id