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
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Pulpitis
• Reversible Pulpitis

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