Comparison of Success Rate between Direct Pulp Capping and Partial Pulpotomy by Using RetroMTA in Primary Molars with Carious Pulp exposure: A Randomized Controlled Trial

Phase 3

Recruiting

• Conditions: Direct Pulp Capping; Vital pulp therapy; Primary molars with carious pulp exposure; Partial pulpotomy

• Registration Number: TCTR20240508001
• Lead Sponsor: Faculty of Dentistry, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-08
• Last Update Posted: 19 August 2024
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1)Patients aged between 3 and 9 years.
2)Patients and guardians are willing to attend and compliance to follow-up
3)Healthy patients (ASA class I and II)
4)Patients has at least one primary molar tooth with deep carious lesion
5)Tooth should be restorable with stainless steel crown
6)Tooth has no history of soft tissue swelling, fistula tract, and pathologic mobility
7)Exposure size not exceeding 1 mm. (pinpoint exposure)
8)Bleeding should be controlled within 5 minutes
9)Radiographically, radiolucency reaching inner one-third of dentin
10)Radiographically, absence of pathological internal or external root resorption and radiolucency at the periapical or furcation areas
11)Radiographically, absence of root canal obliteration or dentin bridge formation

Exclusion Criteria

1)Patients with ASA class II and IV
2)Patients age below 3 years and more than 9 years
3)Patients and guardians are not willing to attend
4)Tooth can not be restorable with stainless steel crown
5)Tooth has history of soft tissue swelling, fistula tract, and pathologic mobility
6)Exposure size exceeding more than 1 mm.
7)Bleeding can not controlled within 5 minutes
8)Radiographically, radiolucency not reaching inner one-third of dentin
9)Radiographically, presence of pathological internal or external root resorption and radiolucency at the periapical or furcation areas
10)Radiographically, presence of root canal obliteration or dentin bridge formation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of Direct Pulp Capping and Partial Pulpotomy by Using RetroMTA in Primary Molars with Carious Pulp Exposure at 6 and 12 months after end of the intervention Percentage of success in each group was calculated. The success outcomes of two groups were compared using the Chi-square test at a significance level of 0.05

Secondary Outcome Measures

Name	Time	Method
Clinical and Radiographical outcome at 6 and 12 months after end of the intervention Clinical and Radiographical examination