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

Phase 4

Completed

• Conditions: Indirect Pulp Cap
• Interventions: Drug: Calcium Hydroxide (Ca(OH)2); Drug: MTA pulp dressing material

• Registration Number: NCT06807320
• Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group I patients, Calcium hydroxide	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.
Group II patients, MTA	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.

Primary Outcome Measures

Name	Time	Method
Dentine bridge thickness (DBT)	3 and 6 months follow up appointment in all successful cases.	Dentine bridge thickness (DBT) was measured at the 3 and 6 months follow up appointment in all successful cases.

Trial Locations

Locations (1)

Pakistan Institute of Medical Sciences; 🇵🇰 Islamabad, Capital, Pakistan