Dental Restoration Failure of Marginal IntegrityOPUSFCLASSIINCT06183320
Can Flowable Bulk Fill Composites be Used in Proximal Area of Class II Restorations
A study testing Restoration with Incremental Composite in Proximal Wall and Restoration with Bulk Fill Composite in Proximal Wall in people with Dental Restoration Failure of Marginal Integrity, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Restoration with Incremental Composite in Proximal Wall and Restoration with Bulk Fill Composite in Proximal Wall
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2019to 8 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Volunteers with periodontal disease
- Volunteers with gingival bleeding
- Volunteers that have uses anti-inflammatory drugs in the last 30 days
- Pregnant volunteers
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal Fluminense - School of Dentistry
Nova Friburgo, Rio de Janeiro, 28625-650
About this study
Official title: Can Flowable Bulk Fill Composites be Used in Proximal Area of Class II Restorations: A Double-blinded Randomized Clinical Trial
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.
Read the detailed description
This is a 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. All 38 enrolled patients will receive 76 Class II dental restorations, made in two different ways, one from each experimental group. All patients must have at only 20 teeth in function, must have at only 2 carious lesion in 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 3 mm deep in occlusal area and more than 5 mm deep in at only one proximal area, 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. Proximo-occlusal lesions will receive the self-etch adhesive system Ambar Universal APS with selective acid etching, according to the manufacturers instrucions. Then, 2 different restorative protocols will be performed divided in two groups. Group Bulk Flow Proximal (BP): 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; Group Incremental Proximal (IP): Initially, 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. 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.
- Being tested
- Restoration with Incremental Composite in Proximal Wall, Restoration with Bulk Fill Composite in Proximal Wall
- Keywords
- Composite restorations, Bulk fill composites, Tooth sensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration with Incremental Composite in Proximal WallProcedure or surgery
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.
Restoration with Bulk Fill Composite in Proximal WallProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Restoration with Bulk Fill Composite in Proximal Wall |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five years
Secondary outcomes (6)
Marginal Pigmentation
It will be evaluated the increase in the number of dental restorations with marginal pigmentation in the period of five years, verified by periodic clinical visual examination (6/6 months) based on the statement of difference of at least 25% in the amount of stained restorations in the different groups.
Measured: Five years
Post-Operative Hypersensitivity
It will be evaluated the increase in the number of dental restorations with dentin hypersensitivity in the period of five years, verified by periodic clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with dentin hypersensitivity in the different groups.
Measured: Five years
Secondary Caries
It will be evaluated the increase in the number of dental restorations with secondary caries in the period of five years, verified by periodic radiographic examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with secondary caries in the different groups.
Measured: Five years
Marginal Adaptation
It will be evaluated the increase in the number of dental restorations with problems in the marginal adaptation in the period of five years, verified by periodic clinical visual examination (6/6 months) based on the statement of difference of at least 25% in the amount of stained restorations in the different groups.
Measured: Five years
Color Match
It will be evaluated the increase in the number of dental restorations with changes in the color of the restoration after clinical use, in the period of five years, verified by periodic clinical visual examination (6/6 months) based on the statement of difference of at least 25% in the amount of stained restorations in the different groups.
Measured: Five years
Proximal Contact Quality
It will be evaluated the increase in the number of dental restorations with problems in proximal contact of the restoration after clinical use, in the period of five years, verified by periodic clinical visual examination (6/6 months) based on the statement of difference of at least 25% in the amount of stained restorations in the different groups.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start5 Aug 2019
- Primary completion2 Jun 2020
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Dental Restoration Failure of Marginal IntegrityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARCOS O BARCELEIRO, PhD, Study director, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183320
- Sponsor's protocol ID
- ISNFUFFBULKFGM1
- Acronym
- OPUSFCLASSII
- Status last verified
- May 2026
- First submitted
- 13 Dec 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28281590Tardem 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.
PubMed 31531552van 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.
PubMed 28524243van 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.
PubMed 24958689Reis 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.
PubMed 26122377Hirani 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.
PubMed 30596045da 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.
PubMed 27523636Vianna-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.
PubMed 29208783Guney 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.
PubMed 31693438Schulz 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.
PubMed 22019563Costa 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.
PubMed 27892839Loguercio 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.
PubMed 31100332
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Flowable Bulk Fill Composites be Used in Proximal Area of Class II Restorations: A Double-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06183320
- Acronym / sponsor ID
- OPUSFCLASSII / ISNFUFFBULKFGM1
- Keywords
- Composite restorations, Bulk fill composites, Tooth sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 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. All 38 enrolled patients will receive 76 Class II dental restorations, made in two different ways, one from each experimental group. All patients must have at only 20 teeth in function, must have at only 2 carious lesion in 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 3 mm deep in occlusal area and more than 5 mm deep in at only one proximal area, 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. Proximo-occlusal lesions will receive the self-etch adhesive system Ambar Universal APS with selective acid etching, according to the manufacturers instrucions. Then, 2 different restorative protocols will be performed divided in two groups. Group Bulk Flow Proximal (BP): 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; Group Incremental Proximal (IP): Initially, 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incremental Composite in Proximal Wall | Active comparator | Procedure: Restoration with Incremental Composite in Proximal Wall38 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. |
| Bulk Fill Composite in Proximal Wall | Experimental | Procedure: Restoration with Bulk Fill Composite in Proximal Wall38 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Volunteers with periodontal disease
- Volunteers with gingival bleeding
- Volunteers that have uses anti-inflammatory drugs in the last 30 days
- Pregnant volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restoration with Incremental Composite in Proximal WallProximo-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. | Procedure or surgery | Incremental Composite in Proximal Wall |
| Restoration with Bulk Fill Composite in Proximal WallProximo-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. | Procedure or surgery | Bulk Fill Composite in Proximal Wall |
Primary outcome
Restoration Loss
Time frame: Five years
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.
6 secondary outcomes
Marginal Pigmentation
Time frame: Five years
Post-Operative Hypersensitivity
Time frame: Five years
Secondary Caries
Time frame: Five years
Marginal Adaptation
Time frame: Five years
Color Match
Time frame: Five years
Proximal Contact Quality
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 28281590Chesterman 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.
- Background: PubMed 31531552Tardem 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.
- Background: PubMed 28524243van 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.
- Background: PubMed 24958689van 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.
- Background: PubMed 26122377Reis 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.
- Background: PubMed 30596045Hirani 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.
- Background: PubMed 27523636da 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.
- Background: PubMed 29208783Vianna-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.
- Background: PubMed 31693438Guney 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.
- Background: PubMed 22019563Schulz 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.
- Background: PubMed 27892839Costa 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.
- Background: PubMed 31100332Loguercio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARCOS O BARCELEIRO, PhD study director
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restoration with Incremental Composite in Proximal Wall and Restoration with Bulk Fill Composite in Proximal Wall in people with Dental Restoration Failure of Marginal Integrity, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration Loss (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06183320, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.