Conservative Pulp Therapy of Primary Molars Using TheraCAL

Phase 3

Completed

• Conditions: Reversible Pulpitis
• Interventions: Drug: Dual cured resin modified tricalcium silicate cement

• Registration Number: NCT04167943
• Lead Sponsor: Ain Shams University

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2019-10-26
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Study Start: 2019-11-25
• Primary Completion: 2021-08-01
• Study Completion: 2021-09-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
indirect pulp capping	Dual cured resin modified tricalcium silicate cement	TheraCAL PT will be applied to affected dentin covering the pup.
Direct pulp Capping	Dual cured resin modified tricalcium silicate cement	TheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin.
Partial Pulpotomy	Dual cured resin modified tricalcium silicate cement	Pulp exposure will be enlarged to a depth of 1-3 mm by a sterile round diamond bur, and then TheraCAL PT will applied after hemostasis.
pulpotomy	Dual cured resin modified tricalcium silicate cement	complete removal of coronal pulp tissue will be attempted if bleeding persisted after attempting Partial pulpotomy for exposures that are not eligible for DPC. TheraCAL PT will be applied thereafter, after achieving hemostasis.

Primary Outcome Measures

Name	Time	Method
Changes in Visual and tactile clinical examination	every 6 months	Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis

Secondary Outcome Measures

Name	Time	Method
Change in Dental Periapical Radiographic examination	every 6 months	Teeth will be examined for any radiographic signs of pulp necrosis

Trial Locations

Locations (1)

Faculty of Dentistry, Ain Shams University; 🇪🇬 Cairo, Egypt