Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA

Cairo University (CU)

Status: Unknown

Conditions: Clinical Evaluation Including Pain and Swelling

Treatments: Drug: Novel fast-setting calcium silicate cement (Protooth)

Study type: Interventional

Funder types: Other

Identifiers

NCT04710160

Pedo193

Details and patient eligibility

About

The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.

Enrollment: 40 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs

• No allergic reactions recorded in patient history

• Having primary molar teeth in one jaw, having deep caries and vital pulp.

• No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule

• Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test

  • Radiographic criteria:

• No sign of radiolucency in periapical or furcation area

• No widening of PDL space or loss of lamina dura continuity

• No evidence of internal/external pathologic root resorption

Exclusion criteria

• Lack of informed consent by the child patient's parent
• Lack of informed consent by the child patient's parent
• Unable to attend follow-up visits.
• Refusal of participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Novel fast setting calcium silicate ( Protooth)

Active Comparator group

Description:

In the form of powder and liquid to be mixed together to form paste.

Treatment:

Drug: Novel fast-setting calcium silicate cement (Protooth)

MTA

Experimental group

Description:

In form of powder to be mixed with saline to form paste.

Treatment:

Drug: Novel fast-setting calcium silicate cement (Protooth)