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NCT04167943 Clinical Trial

Conservative Pulp Therapy of Primary Molars Using TheraCAL

Reversible Pulpitis Clinical Trial

Official title:
Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04167943
Other study ID # FDASU-REC R 091902
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 25, 2019
Est. completion date September 1, 2021

Study information
Verified date June 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).

Description:

Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.

Recruitment information / eligibility
Status Completed
Enrollment 216
Est. completion date September 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility Inclusion Criteria: - Four to six years old healthy children - Cooperative (frankle scale + and ++) - With at least one vital and restorable primary molar with deep caries. Exclusion Criteria: - History of spontaneous pain, swelling, or sinus tract - Pathological mobility - pain on percussion - Furcation or periapical radiolucency - Internal or external pathological root resorption - Widening of periodontal membrane space - Discontinuity of lamina dura.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dual cured resin modified tricalcium silicate cement
A resin based, dual cured tricalcium silicate based cement

Locations
Country Name City State
Egypt Faculty of Dentistry, Ain Shams University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in Visual and tactile clinical examination Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis every 6 months
Secondary Change in Dental Periapical Radiographic examination Teeth will be examined for any radiographic signs of pulp necrosis every 6 months
See also
  Status Clinical Trial Phase
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Recruiting NCT05144711 - Management of Deep Carious Lesions in Adults N/A
Completed NCT01224925 - RCT of Pulp Capping Over Carious Exposure in Adults N/A
Completed NCT03284697 - Direct Pulp Capping With MTA and Calcium Hydroxide. N/A
Completed NCT03286959 - Effect of Liners on Pulpal Outcome and Restoration Survival After Partial Caries Excavation N/A
Enrolling by invitation NCT02702505 - Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT Phase 4
Active, not recruiting NCT05878249 - Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure N/A
Not yet recruiting NCT06433297 - Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars N/A
Not yet recruiting NCT04617600 - Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars. N/A
Terminated NCT01622153 - Electrical and Formocresol Pulpotomy in Primary Molars N/A
Active, not recruiting NCT03186690 - Similar Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine™ N/A
Active, not recruiting NCT03071588 - Assessment of a New Protocol for Indirect Pulp Capping Procedures N/A
Active, not recruiting NCT02201641 - Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial Phase 4
Recruiting NCT03741816 - Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars N/A
Completed NCT04365270 - Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer Phase 3
Completed NCT05145686 - The Role of Matrix Metalloproteinases on the Primary Teeth Pulpotomy Treatments Phase 1/Phase 2
Completed NCT00187837 - The CAP-1 Trial: Stepwise Excavation Versus One Completed Excavation in Deep Caries N/A
Active, not recruiting NCT04374214 - Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars N/A
Recruiting NCT06435065 - Direct Pulp Capping Agent on Human Pulp Tissue Phase 4
Not yet recruiting NCT04807244 - Treatment of Deep Carious Lesions With Selective Caries Removal, Partial or Full Pulpotomy N/A