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NCT04265833
Evaluation of Three Different Pulp Capping Materials in Indirect Pulp Treatment of Primary Teeth
NA trial testing Biodentine in Deep Caries in 109 participants. Completed in 7 July 2018.
15 September 2015
Quick facts
| Lead sponsor | Izmir Katip Celebi University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 109 |
| Start date | 8 February 2015 |
| Primary completion | 15 September 2015 |
| Estimated completion | 7 July 2018 |
Drugs / interventions tested
- Biodentine — full drug profile →
- TheraCal LC — full drug profile →
- Calcium hydroxide — full drug profile →
Conditions studied
- Deep Caries — all drugs for Deep Caries →
Sponsor
Izmir Katip Celebi University
Who can join
Adults 5 to 9, any sex, with Deep Caries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical trial was to evaluate the clinical, radiographic, and histopathological success of three different pulp-capping materials in one-stage indirect pulp treatment of primary teeth. The study included a total of 109 patients aged 5-9 years who had primary teeth with deep carious lesions with or symptoms of irreversible pulpitis. The teeth were divided into three groups according to the pulp-capping agents: (I) Calcium hydroxide (Ca\[OH\]2) (control group) (n=36), (II) bioactive tricalcium silicate (Biodentine) (n=37), and (III) resin-based tricalcium silicate (TheraCal LC) (n=36). All the teeth were evaluated clinically and radiographically at postoperative months 6, 12, 18, and 24. A total of 23 primary mandibular second molars that were in their regular exfoliation period (24-40 months) were extracted and fixed in 10% formaldehyde solution. The specimens were evaluated histologically to assess the integrity of the odontoblastic layer, tertiary dentin formation and the quality of the dentin formed, severity of pulpitis, and other pulpal changes.
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 NCT04265833
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Related trials
Other trials of Biodentine
Trials testing the same drug.
- NCT06683833 — Comparison Between Egyptian MTA, Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Materials In Permanent Tee · Phase 4 · recruiting
- NCT07130214 — The Effect of Genetic Polymorphisms on the Success of Vital Pulp Therapy · active not recruiting
- NCT06695208 — Socket Preservation Using Biodentin Versus Xeno Graft for Single Rooted Teeth · Phase 4 · recruiting
- NCT05937100 — New Vital Pulpotomy Medications in Primary Molars · NA · active not recruiting
- NCT06020911 — Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars · Phase 4 · completed
Other recruiting trials for Deep Caries
Currently open trials in the same condition.
- NCT06293521 — Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries · Phase 2 · recruiting
- NCT06683833 — Comparison Between Egyptian MTA, Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Materials In Permanent Tee · Phase 4 · recruiting
- NCT05816525 — The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue · recruiting
- NCT06495242 — Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures · NA · active not recruiting
Other Izmir Katip Celebi University trials
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 NCT04265833 (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 Izmir Katip Celebi University
- Last refreshed: 12 February 2020
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