NCT04397094 is a Phase 4 clinical trial of Theracal LC in Deep Caries, sponsored by Ain Shams University.

Who is sponsoring NCT04397094?

NCT04397094 is sponsored by Ain Shams University.

What drugs are being tested in NCT04397094?

Interventions in NCT04397094: Theracal LC, Formocresol.

What condition does NCT04397094 study?

NCT04397094 studies Deep Caries.

Is NCT04397094 still recruiting?

NCT04397094 is currently completed. Last updated 29 July 2020.

Are results published for NCT04397094?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-07-29 · How we verify

NCT04397094

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

Theracal Pulpotomy in Primary Molars

Completed Phase 4 Results posted Last updated 29 July 2020

What this trial tests

Phase 4 trial testing Theracal LC in Deep Caries in 60 participants. Completed in 30 March 2019.

Timeline

1 December 2017

Primary endpoint
17 March 2018

30 March 2019

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 December 2017
Primary completion	17 March 2018
Estimated completion	30 March 2019
Sites	1 location across Egypt

Drugs / interventions tested

Theracal LC — full drug profile →
Formocresol — full drug profile →

Conditions studied

Deep Caries — all drugs for Deep Caries →

Sponsor

Ain Shams University

Who can join

Adults 4 to 7, any sex, with Deep Caries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Examination Primary · 12 months

Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion.

Group	Value	95% CI
Theracal LC	30
Formocresol	30

Radiographic Examination Secondary · 12 months

Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space.

Group	Value	95% CI
Theracal LC	30
Formocresol	30

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Theracal LC

Serious: 0/30 (0%)

Deaths: 0/30

Formocresol

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (2 terms — click to expand)

Reaction	System	Theracal LC	Formocresol
internal resorption	Musculoskeletal and connective tissue disorders	—	—
interradicular bone resorption	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT04397094 adverse events section.

Sponsor's own description

Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.

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:

Other trials of Theracal LC

Trials testing the same drug.

NCT05733468 — TheraCal LC Coronal Pulpotomy and MTA Coronal Pulpotomy in Mature Permanent Molars · Phase 4 · unknown

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 Ain Shams University trials

Trials by the same sponsor.

NCT07435493 — Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstru · NA · not yet recruiting
NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
NCT07531030 — Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blo · NA · not yet recruiting
NCT06839027 — Arterial to Central co2gap in Relation to Outcome After Cardiopulmonary Bypass · not yet recruiting
NCT07516535 — DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones · NA · not yet 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 NCT04397094 (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 Ain Shams University
Last refreshed: 29 July 2020

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/NCT04397094.

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