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

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

Sponsors

Lead sponsor: Universidade Federal Fluminense

Source Universidade Federal Fluminense
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.

Overall Status Active, not recruiting
Start Date August 1, 2018
Completion Date September 2023
Primary Completion Date March 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Restoration Loss Five years
Secondary Outcome
Measure Time Frame
Marginal Pigmentation Five years
Post-Operative Hypersensitivity Five years
Secondary Caries Five years
Enrollment 53
Condition
Intervention

Intervention type: Procedure

Intervention name: Bulk without surface sealant

Description: 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.

Arm group label: Bulk without Surface Sealant

Intervention type: Procedure

Intervention name: Bulk with Biscover

Description: 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.

Arm group label: Bulk with Biscover

Intervention type: Procedure

Intervention name: Bulk with Permaseal

Description: 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.

Arm group label: Bulk with Permaseal

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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
MARCOS O BARCELEIRO, DDS, PHD Study Director Universidade Federal Fluminense
Location
facility Universidade Federal Fluminense - School of Dentistry
Location Countries

Brazil

Verification Date

April 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: Bulk without Surface Sealant

Arm group type: Active Comparator

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

Arm group label: Bulk with Biscover

Arm group type: Experimental

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

Arm group label: Bulk with Permaseal

Arm group type: Experimental

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

Acronym SEALBULK
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov