NCT03135626 is a Phase 3 clinical trial of Biodentine in Extensive Decay in Primary Molars, sponsored by Istanbul University.

Who is sponsoring NCT03135626?

NCT03135626 is sponsored by Istanbul University.

What drugs are being tested in NCT03135626?

Interventions in NCT03135626: Biodentine, ProRoot (Aggregate), MTA Plus, Ferric Sulfate 20 % Dental Gel.

What condition does NCT03135626 study?

NCT03135626 studies Extensive Decay in Primary Molars.

Is NCT03135626 still recruiting?

NCT03135626 is currently completed. Last updated 1 May 2017.

Last reviewed 2017-05-01 · How we verify

NCT03135626

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of The Success Rates of Four Different Pulpotomy Techniques

Completed Phase 3 Last updated 1 May 2017

What this trial tests

Phase 3 trial testing Biodentine in Extensive Decay in Primary Molars in 38 participants. Completed in 15 February 2016.

Timeline

15 March 2013

Primary endpoint
15 January 2014

15 February 2016

Quick facts

Lead sponsor	Istanbul University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	38
Start date	15 March 2013
Primary completion	15 January 2014
Estimated completion	15 February 2016

Drugs / interventions tested

Biodentine — full drug profile →
ProRoot (Aggregate) — full drug profile →
MTA Plus — full drug profile →
Ferric Sulfate 20 % Dental Gel — full drug profile →

Conditions studied

Extensive Decay in Primary Molars — all drugs for Extensive Decay in Primary Molars →

Sponsor

Istanbul University

Who can join

Adults 5 to 7, any sex, with Extensive Decay in Primary Molars. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Success Rates of Pulpotomies in Primary Molars Using Calcium Silicate-Based Materials: A Randomized Control Trial.
Guven Y, Aksakal SD, Avcu N, Unsal G, et al · · 2017 · cited 17× · PMID 29226134 · DOI 10.1155/2017/4059703

Verify or expand the search:

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 Istanbul University trials

Trials by the same sponsor.

NCT07472946 — Whole-Body Vibration Exercise in Patients With Parkinson's Disease · NA · not yet recruiting
NCT07433894 — Scoliosis and Functional Outcomes in Children With Juvenile Idiopathic Arthritis · not yet recruiting
NCT07420049 — Turkish Adaptation of the CTS-6 Evaluation Tool: A Validation and Reliability Study · not yet recruiting
NCT07415967 — The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain · NA · recruiting
NCT07473024 — pEEG-Guided Anesthesia and Behavioral Outcomes in Children · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03135626 (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 Istanbul University
Last refreshed: 1 May 2017

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/NCT03135626.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing