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Completed

NCT Number: NCT06807320

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

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.

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Key information

Conditions

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pakistan Institute of Medical Sciences

Islamabad, Capital, 44000, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MTA pulp dressing material

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.

Calcium Hydroxide (Ca(OH)2)

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.

Primary outcomes

  1. Dentine bridge thickness (DBT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Other

Registry information

Official study title

CLINICAL and RADIOGRAPHIC COMPARISON of MINERAL TRIOXIDE AGGREGATE and CALCIUM HYDROXIDE AS INDIRECT PULP CAPPING AGENTS in PRIMARY MOLARS: a RANDOMIZED CLINICAL TRIAL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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