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NCT06749977
P11-4 and Fluoride Varnish for Remineralization of Post-orthodontic Lesions
NA trial testing Remineralization with SAP11-4 in White Spot Lesions in 45 participants. Completed in 20 February 2023.
1 January 2021
Quick facts
| Lead sponsor | Medical University of Sofia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 1 January 2020 |
| Primary completion | 1 January 2021 |
| Estimated completion | 20 February 2023 |
| Sites | 1 location across Bulgaria |
Drugs / interventions tested
- Remineralization with SAP11-4 — full drug profile →
- Remineralization with sodium fluoride varnish — full drug profile →
Conditions studied
- White Spot Lesions — all drugs for White Spot Lesions →
Sponsor
Medical University of Sofia
Who can join
Adults 18 to 30, any sex, with White Spot Lesions. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical study aims to compare the remineralizing effects of self-assembling peptide P11-4 (SAP11-4) with fluoride varnish in the treatment of post-orthodontic non-cavitated carious lesions (NCLs). The study uses the QLF camera to assess changes in lesion size, severity, and mineralization, evaluating the effectiveness of SAP11-4 in comparison to fluoride varnish or no treatment. The primary endpoint is the change in QLF parameters, alongside ICDAS scores and Nyvad criteria for clinical evaluation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06749977
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for White Spot Lesions
Currently open trials in the same condition.
- NCT07426432 — Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Thera · NA · active not recruiting
- NCT06616207 — Topical 10% Povidone-Iodine in Preventing White Spots · Phase 2 · recruiting
- NCT06696105 — Assessing the Effects of Resin Infiltration and Resin Modified Glass Ionomer on the Color Changes of White Spot Lesions · Phase 4 · active not recruiting
- NCT05733676 — Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment · NA · recruiting
Other Medical University of Sofia trials
Trials by the same sponsor.
- NCT07493278 — Er,Cr:YSGG Laser Versus Conventional Preparation for Minimally Invasive Caries Removal · NA · completed
- NCT06974201 — The Effect of Diabetes M Application Use Versus Conventional Bolus Calculation in Patients With Type 1 Diabetes Mellitus · NA · active not recruiting
- NCT07358429 — CPAP Therapy and Atrial Fibrillation Recurrence in OSA · active not recruiting
- NCT06415825 — Preliminary Muscle Contraction in the Rehabilitation and Prevention of Degenerative Pain in the Locomotor System · NA · not yet recruiting
- NCT07230522 — Effectiveness of Hyaluronic Acid (hyaDENT BG® Gel) Compared With Enamel Matrix Proteins (Emdogain®) in the Treatment of · NA · completed
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 NCT06749977 (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 Medical University of Sofia
- Last refreshed: 27 December 2024
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/NCT06749977.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing