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

NCT03924830 | Active Not Recruiting

• 1 other identifier: UFFBULKSEAL2018
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Restoration Failure of Marginal Integrity

Keywords

dentin bonding agents; tooth sensitivity; composite resin restoration

Outcome Measures

Primary Outcomes (1)

• Restoration Loss

  It will be evaluated the increase in the number of losses of dental restorations in the period of five years, verified by periodic visual clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of remaining restorations in the different groups.

  Five years

Secondary Outcomes (3)

• Marginal Pigmentation

  Five years

• Post-Operative Hypersensitivity

  Five years

• Secondary Caries

  Five years

Study Arms (3)

Bulk without Surface Sealant

ACTIVE COMPARATOR

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

Procedure: Bulk without surface sealant

Bulk with Biscover

EXPERIMENTAL

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

Procedure: Bulk with Biscover

Bulk with Permaseal

EXPERIMENTAL

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

Procedure: Bulk with Permaseal

Interventions

Bulk without surface sealant 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 without Surface Sealant

Bulk with Biscover 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 Biscover

Bulk with Permaseal 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.

Bulk with Permaseal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense - School of Dentistry

Nova Friburgo, Rio de Janeiro, 28625-650, Brazil

Location

Related Publications (7)

• Abbas G, Fleming GJ, Harrington E, Shortall AC, Burke FJ. Cuspal movement and microleakage in premolar teeth restored with a packable composite cured in bulk or in increments. J Dent. 2003 Aug;31(6):437-44. doi: 10.1016/s0300-5712(02)00121-5.

  PMID: 12878027 BACKGROUND

• Moorthy A, Hogg CH, Dowling AH, Grufferty BF, Benetti AR, Fleming GJ. Cuspal deflection and microleakage in premolar teeth restored with bulk-fill flowable resin-based composite base materials. J Dent. 2012 Jun;40(6):500-5. doi: 10.1016/j.jdent.2012.02.015. Epub 2012 Mar 3.

  PMID: 22390980 BACKGROUND

• Roggendorf MJ, Kramer N, Appelt A, Naumann M, Frankenberger R. Marginal quality of flowable 4-mm base vs. conventionally layered resin composite. J Dent. 2011 Oct;39(10):643-7. doi: 10.1016/j.jdent.2011.07.004. Epub 2011 Jul 27.

  PMID: 21801799 BACKGROUND

• van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015 Feb;17(1):81-8. doi: 10.3290/j.jad.a33502.

  PMID: 25625133 BACKGROUND

• Bayraktar Y, Ercan E, Hamidi MM, Colak H. One-year clinical evaluation of different types of bulk-fill composites. J Investig Clin Dent. 2017 May;8(2). doi: 10.1111/jicd.12210. Epub 2016 Jan 22.

  PMID: 26800647 BACKGROUND

• 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.

  PMID: 27892839 BACKGROUND

• 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.

  PMID: 38142146 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Dietary Fiber; BisCover; PermaSeal

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• MARCOS O BARCELEIRO, DDS, PHD

  Universidade Federal Fluminense

  STUDY DIRECTOR

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: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: August 1, 2018
• Primary Completion: March 30, 2019
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)