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

Not Applicable

• Conditions: Clinical Evaluation Including Pain and Swelling
• Interventions: Drug: Novel fast-setting calcium silicate cement (Protooth)

• Registration Number: NCT04710160
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Status Verified: 2021-08
• Study Start: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05
• Primary Completion: 2022-10-22
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel fast setting calcium silicate ( Protooth)	Novel fast-setting calcium silicate cement (Protooth)	In the form of powder and liquid to be mixed together to form paste.
MTA	Novel fast-setting calcium silicate cement (Protooth)	In form of powder to be mixed with saline to form paste.

Primary Outcome Measures

Name	Time	Method
Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS	12 months	Post-operative pain following pulpotomy treatment will be measured.; A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.

Secondary Outcome Measures

Name	Time	Method
Radiographic evaluation following the Pulpotomy treatment will be measured	12 months	Binary assessment of the radiographs taken after the treatment ( if there is any radiolucent or widening in the lamina sure nor evidence of internal/external pathologic root resorption)

Trial Locations

Locations (1)

Faculty of Dentsitry , Cairo University; 🇪🇬 Cairo, El Manial, Egypt