NCT06807320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 29, 2025

Last Update Submit

January 29, 2025

Conditions

Indirect Pulp Cap

Keywords

Indirect Pulp capprimary molarMTA

Outcome Measures

Primary Outcomes (1)

  • Dentine bridge thickness (DBT)

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

    3 and 6 months follow up appointment in all successful cases.

Study Arms (2)

Group I patients, Calcium hydroxide

ACTIVE COMPARATOR

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.

Drug: Calcium Hydroxide (Ca(OH)2)

Group II patients, MTA

EXPERIMENTAL

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.

Drug: MTA pulp dressing material

Interventions

MTA pulp dressing materialDRUG

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 II patients, MTA
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.

Group I patients, Calcium hydroxide

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, Capital, 44000, Pakistan

Location

MeSH Terms

Interventions

Calcium Hydroxide

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

January 1, 2022

Primary Completion

January 1, 2024

Study Completion

December 30, 2024

Last Updated

February 4, 2025

Record last verified: 2025-01

Locations

PA(1)