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NCT05236205
Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions
Phase 2 trial testing Caries removal with a lowspeed drill in Caries in 160 participants. Status unknown.
30 November 2022
Quick facts
| Lead sponsor | University of Nove de Julho |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 160 |
| Start date | 30 May 2022 |
| Primary completion | 30 November 2022 |
| Estimated completion | 20 December 2022 |
Drugs / interventions tested
- Caries removal with a lowspeed drill
- Partial removal of carious tissue with the administration of Papacarie™
- Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%)
- Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT)
Conditions studied
- Caries — all drugs for Caries →
Sponsor
University of Nove de Julho
Who can join
Adults 6 to 12, any sex, with Caries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Alternatively to conventional treatments, chemo-mechanical caries removal agents can be used. A modality of treatment that has been increasing in dentistry is antimicrobial photodynamic therapy (aPDT). Bixa orellana, is being researched for application in aPDT. This protocol aims to determine the effectiveness of aPDT with Bixa orellana extract in deep caries lesions. Methods and analysis: A total of 160 teeth with deep occlusal dental caries will be selected and divided in 3 groups: G1 - control group (Caries removal with a lowspeed drill); G2 - Partial Caries Removal with Papacarie; G3 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%); G4 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%) with LED (aPDT). After treatment, all the teeth will be restored with glass ionomer cement and followed up clinically and radiographically, with evaluations at immediately, 1 week, 1, 3, 6, and 12 months. Dentin samples before and after treatment will be analyzed microbiologically. The data will be submitted to descriptive statistical analysis of the association between the categorical variables using the chi-square test and Fisher exact text. The Student t test and analysis of variance will be used for the comparison of mean signs and symptoms of reversible pulpitis. Pearson correlation coefficients will be calculated for the analysis of correlations among the continuous variables.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Investigation on the effect of antimicrobial photodynamic therapy as an adjunct for management of deep caries lesions-study protocol for a randomized, parallel groups, controlled clinical trial.
Martins LFB, de Sena LR, de Paula DM, Feitosa VP, et al · · 2023 · cited 3× · PMID 36870982 · DOI 10.1186/s13063-023-07181-8 -
Antimicrobial photodynamic therapy as an adjunct for management of deep caries lesions - Study protocol for a randomized, controlled clinical trial
Martins LFB, de Sena LR, de Paula DM, Feitosa VP, et al · · 2022 · DOI 10.21203/rs.3.rs-1808429/v1
Verify or expand the search:
- PubMed search for NCT05236205
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05236205 (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 University of Nove de Julho
- Last refreshed: 17 May 2022
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/NCT05236205.
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