COMPARISON of MINERAL TRIOXIDE AGGREGATE and CALCIUM HYDROXIDE AS INDIRECT PULP CAPPING AGENTS in PRIMARY MOLARS

NCT ID: NCT06807320

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-30

Brief Summary

The study is designed as randomized clinical trial performed at the Department of Pediatric Dentistry , Pakistan Institute of Medical Sciences (PIMS) , Islamabad on primary molars requiring indirect pulp treatment in patients aged 5 to 9 years. Two groups , I and II of 40 teeth each will be selected according to inclusion criteria . In Group I , indirect pulp capping will be done with Calcium hydroxide while in Group II , it will be done with MTA . Both the groups will be evaluated clinically and radiographically at 0, 3 and 6 months . Results were compiled and analyzed using standard statistical techniques.

Conditions

Indirect Pulp Cap

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I patients, Calcium hydroxide

For Group I patients, Calcium hydroxide (Dycal\_ Ivory,Dentsply Caulk, Dentsply, L.D. Caulk, Milford, DE,USA ) was used. The catalyst and paste were mixed as per the manufacturer's recommendations.

Group Type: ACTIVE_COMPARATOR

Calcium Hydroxide (Ca(OH)2)

Intervention Type: DRUG

For Group I patients, Calcium hydroxide (Dycal\_ Ivory,Dentsply Caulk, Dentsply, L.D. Caulk, Milford, DE,USA ) was used. The catalyst and paste were mixed as per the manufacturer's recommendations.

Group II patients, MTA

MTA powder ( ProRoot; Dentsply ⁄ Tulsa Dental, Tulsa, OK,USA) was added to sterile water. The mixture was left to achieve a sandy consistency for about thirty seconds. Then, the material was applied to the cavity using a ball condenser.

Group Type: EXPERIMENTAL

MTA pulp dressing material

Intervention Type: DRUG

MTA powder ( ProRoot; Dentsply ⁄ Tulsa Dental, Tulsa, OK,USA) was added to sterile water. The mixture was left to achieve a sandy consistency for about thirty seconds. Then, the material was applied to the cavity using a ball condenser.

Interventions

MTA pulp dressing material

MTA powder ( ProRoot; Dentsply ⁄ Tulsa Dental, Tulsa, OK,USA) was added to sterile water. The mixture was left to achieve a sandy consistency for about thirty seconds. Then, the material was applied to the cavity using a ball condenser.

Intervention Type: DRUG

Calcium Hydroxide (Ca(OH)2)

For Group I patients, Calcium hydroxide (Dycal\_ Ivory,Dentsply Caulk, Dentsply, L.D. Caulk, Milford, DE,USA ) was used. The catalyst and paste were mixed as per the manufacturer's recommendations.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical Criteria :

• Primary molars with deep carious lesions
• No H/O spontaneous pain
• No associated swelling
• No tenderness to percussion
• Absence of pathological mobility
• No sinus tract
• Restorable

Radiographic Criteria :

• No periapical radiolucency
• No loss of lamina dura
• No physiological root resorption
• Teeth with radiographic evidence of more than 0.25mm remaining dentin thickness
• No furcal radiolucency

Exclusion Criteria

• Non restorable teeth

• Teeth with pathological mobility
• Teeth with extensive external/internal root resorption.
• Teeth with pulp canal calcifications
• Subjects inability to tolerate any of the dental products being used
• Systemic disease or severe medical complications ; Lack of compliance

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role: lead

Responsible Party

RANA AHMAD

ASSISTANT PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pakistan Institute of Medical Sciences

Islamabad, Capital, Pakistan

Countries

Pakistan

Other Identifiers

F.1-1/2015/ERB/SZABMU/ERB

Identifier Type: -

Identifier Source: org_study_id