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

NCT ID: NCT05554952

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-11-30

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

Conditions

Indirect Pulp Capping; Pulpotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Indirect pulp capping with MTA

Group Type: ACTIVE_COMPARATOR

MTA

Intervention Type: COMBINATION_PRODUCT

Mineral trioxide aggregate (MTA) is composed of Portland cement, with 4:1 addition of bismuth oxide added so that the material can be detected on a radiograph. The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.

Group 2

Pulpotomy with MTA

Group Type: ACTIVE_COMPARATOR

MTA

Intervention Type: COMBINATION_PRODUCT

Mineral trioxide aggregate (MTA) is composed of Portland cement, with 4:1 addition of bismuth oxide added so that the material can be detected on a radiograph. The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.

Interventions

MTA

Mineral trioxide aggregate (MTA) is composed of Portland cement, with 4:1 addition of bismuth oxide added so that the material can be detected on a radiograph. The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Hasnaa monis

Resident in pediatric dentistry department faculty of dentistry assuit university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Minia University

Minya, , Egypt

Minia University

Minya, , Egypt

Countries

Egypt

Other Identifiers

526_1 /11/2021

Identifier Type: -

Identifier Source: org_study_id