Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries

Not Applicable

Active, not recruiting

• Conditions: Pulpotomy; Indirect Pulp Capping
• Interventions: Combination Product: MTA

• Registration Number: NCT05554952
• Lead Sponsor: Minia University

Brief Summary

The aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period.

Detailed Description

Output patients coming to Pediatric dentistry department Minia University, selected randomly to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period an equivalent parallel randomized controlled trial

Study Timeline

• Study Start: 2021-11-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• • 4 to 6 years old patients presented with deep carious lesions in primary molars.
• Apparently healthy children (ASA I, II classification).
• Co-operative children (Rating 3 & 4 according to Frankle classification)

Exclusion Criteria

A) Clinical:

• Non restorable primary molars.

• Presence of clinical pathology.

• Presence of mobility or tenderness to percussion.

  • Spontaneous pain.

B) Radiographic:

• Pre-operative radiographs showed external or internal root resorption.
• Presence of furcal radiolucency.
• Presence of periapical radiolucency or widened periodontal ligament space
• More than one-third root resorption detected.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	MTA	Indirect pulp capping with MTA
Group 2	MTA	Pulpotomy with MTA

Primary Outcome Measures

Name	Time	Method
Clinical and radiographic evaluation	2 years follow up	The children will be recalled for postoperative clinical and radiographic assessment at the following intervals: 3, 6, 12 months the treatment will be considered successful if none of the following clinical or radiographic findings is present: Clinical criteria: 1. pain; 2. tenderness to palpation or percussion; 3. gingival swelling or sinus tract; 4. purulent exudate expressed from the gingival margin; 5. abnormal tooth mobility; Radiographic criteria: 1. periapical radiolucency; 2. widening in peridontal ligament space

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Egypt