CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Formocresol +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05190783
NCT05190783Phase 4Completed

Partial Versus Complete Pulpotomy Using Three Different Materials in Primary Molars: a Clinical Study

Mansoura University·interventional·Posted Jan 13, 2022·Updated Jan 18, 2022

In Brief

A Phase 4 clinical trial evaluating Formocresol, MTA, and 3 other interventions for Decayed Primary Molars. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purposes of the study to compare partial pulpotomy versus complete pulpotomy in primary molars using three different materials (Formocresol, MTA, Theracal LC) . After 6, 9, 12 and 15 months follow up each case will be evaluated radiographically and clinically. the radiographic criteria to be evaluated are (radiolucency, resorption, widening in periodontal ligament space, Crypt involvement) and clinical criteria are ( pain, tenderness, fistula, abnormal mobility) upon these criteria some recommendations will be made on success and failure rate of each material and each technique.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 13, 2022
Enrollment StartMar 1, 2019
Primary CompletionAug 1, 2021
Study CompletionNov 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.5 years ago

Interventions

Formocresoldrug

mixture of formalin, cresol and glycerine used for fixation of pulp tissues

MTAdrug

material used for pulp regeneration, direct and indirect pulp capping

TheraCaldrug

light cured resin modified calcium silicate filled liner designed for use in direct and indirect pulp capping

pulpotomyprocedure

removal of the carious tooth structure and unroofing of the pulp chamber with a round carbide bur with high speed and water spray. The coronal pulp tissue will be then removed using a #4 carbide bur with slow speed and sharp spoon excavator.

partial pulpotomyprocedure

complete removal of caries till exposure occurs. The exposed surface of the pulp will be gently removed using a sterile round diamond bur and a high-speed, water-cooled handpiece with light hand pressure. The removal of the pulp did not exceed approximately two mm.