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NCT05432258
Nano-Hybrid vs Bulk-Fill Resin Composites
NA trial testing Bulk-fill composite resin in Composite Resin in 89 participants. Completed in 26 July 2022.
26 July 2022
Quick facts
| Lead sponsor | Izmir Katip Celebi University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 89 |
| Start date | 15 June 2020 |
| Primary completion | 26 July 2022 |
| Estimated completion | 26 July 2022 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Bulk-fill composite resin
- Nano-fill composite resin
Conditions studied
- Composite Resin — all drugs for Composite Resin →
- Dental Caries in Children — all drugs for Dental Caries in Children →
Sponsor
Izmir Katip Celebi University
Who can join
Adults 6 to 12, any sex, with Composite Resin or Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to compare the 2-year clinical performance of bulk-fill composites, which can be applied as a single layer, and the nano-hybrid filled composite resins, which are frequently used in clinical routine, in children in a split-mouth design. This study was conducted on 89 patients aged 6-12 years who had caries on bilateral mandibular first molars. Our study has a randomized, cross-controlled, and double-blind design. In split-mouth design, restorations of mandibular permanent molars completed with nano-hybrid ORMOCER based bulk-fill filling material Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany) and nano-hybrid composite Grandio (Voco , Cuxhaven, Germany). Futurabond U single dose (Voco, Cuxhaven, Germany) universal adhesive was used for all restorations, in the selective enamel etching mode. The clinical success of the restorations will be evaluated at 6, 12 and 24-month controls. Evaluations has been made by two physicians other than the one who did the restoration, who do not know which restorative material was applied to which tooth.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Two-year evaluation of a nano-hybrid and a bulk-fill resin composite: a randomized, double-blind split-mouth clinical study.
Çağırır Dindaroğlu F, Yılmaz E. · · 2024 · cited 7× · PMID 38467942 · DOI 10.1007/s00784-024-05592-8
Verify or expand the search:
- PubMed search for NCT05432258
- Europe PMC full search
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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 NCT05432258 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Izmir Katip Celebi University
- Last refreshed: 2 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05432258.
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