Can Flowable Bulk Fill Composites be Used in Proximal Area of Class II Restorations

NCT06183320 | Active Not Recruiting

• 1 other identifier: ISNFUFFBULKFGM1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment clinical trial, randomized, controlled, parallel, double-blinded, with two groups, that aims to evaluate the best application strategy when using a flowable bulk fill composite (Opus Bulk Fill Flow APS, FGM, Brazil) in class II cavities. Volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion criteria. All volunteers will be informed and sign a term of clarification and consent. 38 enrolled patients will receive 76 Class II dental restorations, made in two different ways, one from each experimental group. Authors will perform restorations with an incremental composite (Vittra APS - FGM) associated with a bulk-fill flowable composite (Opus Bulk Fill Flow APS - FGM), in class II cavities, exposing (Group BP) or not (Group IP) the bulk fill flowable composite to the cavosurface angle on the proximal wall of the restorations. In both groups, Opus Bulk Fill Flow APS resin will be used in the bulk technique with up to 5mm depth increments, leaving 1 mm in the occlusal for incremental Vittra APS composite resin. 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 FDI 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

Composite restorations; Bulk fill composites; Tooth sensitivity

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 (6)

• Marginal Pigmentation

  Five years

• Post-Operative Hypersensitivity

  Five years

• Secondary Caries

  Five years

• Marginal Adaptation

  Five years

• Color Match

  Five years

Study Arms (2)

Incremental Composite in Proximal Wall

ACTIVE COMPARATOR

38 teeth will receive class II restorations using flowable bulk fill composite to fill the cavities, leaving the proximal wall and the occlusal surface to be restored with traditional incremental composite.

Procedure: Restoration with Incremental Composite in Proximal Wall

Bulk Fill Composite in Proximal Wall

EXPERIMENTAL

38 teeth will receive class II restorations using flowable bulk fill composite to fill the cavities, leaving the occlusal surface to be restored with traditional incremental composite.

Procedure: Restoration with Bulk Fill Composite in Proximal Wall

Interventions

Restoration with Incremental Composite in Proximal Wall PROCEDURE

Proximo-occlusal lesions will receive the self-etch adhesive system Ambar Universal APS with selective acid etching, according to the manufacturers instrucions. Then, proximal wall will be completely restored with Vittra APS composite resin, using the triangular incremental traditional technique described for classe II restorations. Then, Opus Bulk Fill Flow APS will be used in the bulk technique with up to 5mm depth increments, leaving 1 mm in the occlusal for incremental Vittra APS composite resin, that will be used with the traditional incremental technique. Both composites will be light-cured with VALO light-cure unit (Ultradent, USA) for 40 seconds.

Incremental Composite in Proximal Wall

Restoration with Bulk Fill Composite in Proximal Wall PROCEDURE

Proximo-occlusal lesions will receive the self-etch adhesive system Ambar Universal APS with selective acid etching, according to the manufacturers instrucions. Then, Opus Bulk Fill Flow APS resin will be used in the bulk technique with up to 5mm depth increments, leaving 1 mm in the occlusal for incremental Vittra APS composite resin, that will be used with the traditional incremental technique. Both composites will be light-cured with VALO light-cure unit (Ultradent, USA) for 40 seconds.

Bulk Fill Composite in Proximal Wall

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers must have at only 20 teeth in function
• Volunteers must have at only 2 carious proximo-occlusal lesions, or old restorations that need to be changed, in different teeth
• These lesions must be more than 3 mm deep in the oclusal area and more than 5 mm deep in the proximal area, 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
• Volunteers with gingival bleeding
• Volunteers that have uses anti-inflammatory drugs in the last 30 days
• Pregnant volunteers

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 (12)

• Chesterman J, Jowett A, Gallacher A, Nixon P. Bulk-fill resin-based composite restorative materials: a review. Br Dent J. 2017 Mar 10;222(5):337-344. doi: 10.1038/sj.bdj.2017.214.

  PMID: 28281590 BACKGROUND

• Tardem C, Albuquerque EG, Lopes LS, Marins SS, Calazans FS, Poubel LA, Barcelos R, Barceleiro MO. Clinical time and postoperative sensitivity after use of bulk-fill (syringe and capsule) vs. incremental filling composites: a randomized clinical trial. Braz Oral Res. 2019 Sep 16;33(0):e089. doi: 10.1590/1807-3107bor-2019.vol33.0089.

  PMID: 31531552 BACKGROUND

• van Dijken JWV, Pallesen U. Bulk-filled posterior resin restorations based on stress-decreasing resin technology: a randomized, controlled 6-year evaluation. Eur J Oral Sci. 2017 Aug;125(4):303-309. doi: 10.1111/eos.12351. Epub 2017 May 19.

  PMID: 28524243 BACKGROUND

• van Dijken JW, Pallesen U. A randomized controlled three year evaluation of "bulk-filled" posterior resin restorations based on stress decreasing resin technology. Dent Mater. 2014 Sep;30(9):e245-51. doi: 10.1016/j.dental.2014.05.028. Epub 2014 Jun 21.

  PMID: 24958689 BACKGROUND

• Reis A, Dourado Loguercio A, Schroeder M, Luque-Martinez I, Masterson D, Cople Maia L. Does the adhesive strategy influence the post-operative sensitivity in adult patients with posterior resin composite restorations?: A systematic review and meta-analysis. Dent Mater. 2015 Sep;31(9):1052-67. doi: 10.1016/j.dental.2015.06.001. Epub 2015 Jun 27.

  PMID: 26122377 BACKGROUND

• Hirani RT, Batra R, Kapoor S. Comparative Evaluation of Postoperative Sensitivity in Bulk Fill Restoratives: A Randomized Controlled Trial. J Int Soc Prev Community Dent. 2018 Nov-Dec;8(6):534-539. doi: 10.4103/jispcd.JISPCD_218_18. Epub 2018 Nov 29.

  PMID: 30596045 BACKGROUND

• da Veiga AM, Cunha AC, Ferreira DM, da Silva Fidalgo TK, Chianca TK, Reis KR, Maia LC. Longevity of direct and indirect resin composite restorations in permanent posterior teeth: A systematic review and meta-analysis. J Dent. 2016 Nov;54:1-12. doi: 10.1016/j.jdent.2016.08.003. Epub 2016 Aug 11.

  PMID: 27523636 BACKGROUND

• Vianna-de-Pinho MG, Rego GF, Vidal ML, Alonso RCB, Schneider LFJ, Cavalcante LM. Clinical Time Required and Internal Adaptation in Cavities restored with Bulk-fill Composites. J Contemp Dent Pract. 2017 Dec 1;18(12):1107-1111. doi: 10.5005/jp-journals-10024-2184.

  PMID: 29208783 BACKGROUND

• Guney T, Yazici AR. 24-Month Clinical Evaluation of Different Bulk-Fill Restorative Resins in Class II Restorations. Oper Dent. 2020 Mar/Apr;45(2):123-133. doi: 10.2341/18-144-C. Epub 2019 Nov 6.

  PMID: 31693438 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.

  PMID: 22019563 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

• Loguercio AD, Rezende M, Gutierrez MF, Costa TF, Armas-Vega A, Reis A. Randomized 36-month follow-up of posterior bulk-filled resin composite restorations. J Dent. 2019 Jun;85:93-102. doi: 10.1016/j.jdent.2019.05.018. Epub 2019 May 14.

  PMID: 31100332 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• MARCOS O BARCELEIRO, 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: December 13, 2023
• First Posted: December 27, 2023
• Study Start: August 5, 2019
• Primary Completion: June 2, 2020
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)