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NCT06183320: OPUSFCLASSII
Can Flowable Bulk Fill Composites be Used in Proximal Area of Class II Restorations
NA trial testing Restoration with Incremental Composite in Proximal Wall in Dental Restoration Failure of Marginal Integrity in 38 participants. Participants enrolled and being followed up; not accepting new ones.
2 June 2020
Quick facts
| Lead sponsor | Universidade Federal Fluminense |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 5 August 2019 |
| Primary completion | 2 June 2020 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Restoration with Incremental Composite in Proximal Wall
- Restoration with Bulk Fill Composite in Proximal Wall
Conditions studied
- Dental Restoration Failure of Marginal Integrity — all drugs for Dental Restoration Failure of Marginal Integrity →
Sponsor
Universidade Federal Fluminense — full company profile →
Who can join
Adults 18 to 70, any sex, with Dental Restoration Failure of Marginal Integrity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06183320
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06183320 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidade Federal Fluminense
- Last refreshed: 3 April 2025
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