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

Clinical Evaluation Including Pain and Swelling Clinical Trial

Official title:

Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04710160
• Other study ID #: Pedo193
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: November 2022

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: Adel Elbardissy, professor
• Phone: 01271289999
• Email: adelbardissy[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2022
• Est. primary completion date: October 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Evaluation Including Pain and Swelling

Intervention

Drug:
• Novel fast-setting calcium silicate cement (Protooth)
In form of power and liquid to be mixed together to form a paste.

Locations

Country	Name	City	State
Egypt	Faculty of Dentsitry , Cairo University	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS	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.	12 months
Secondary	Radiographic evaluation following the Pulpotomy treatment will be measured	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)	12 months