Conservative Pulp Therapy of Primary Molars Using TheraCAL

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Reversible Pulpitis

Treatments: Drug: Dual cured resin modified tricalcium silicate cement

Study type: Interventional

Funder types: Other

Identifiers

NCT04167943

FDASU-REC R 091902

Details and patient eligibility

About

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).

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 4 patient groups

indirect pulp capping

Experimental group

Description:

TheraCAL PT will be applied to affected dentin covering the pup.

Treatment:

Drug: Dual cured resin modified tricalcium silicate cement

Direct pulp Capping

Experimental group

Description:

TheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin.

Treatment:

Drug: Dual cured resin modified tricalcium silicate cement

Partial Pulpotomy

Experimental group

Description:

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.

Treatment:

Drug: Dual cured resin modified tricalcium silicate cement

pulpotomy

Experimental group

Description:

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.

Treatment:

Drug: Dual cured resin modified tricalcium silicate cement