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

Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries: An Equivalent Parallel Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulpotomy; Indirect Pulp Capping
• Intervention / Treatment: Combination product: MTA

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 2422998
    • Minia University
  • Minya, Egypt
    • Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Indirect pulp capping with MTA	Combination product: 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.
Active Comparator: Group 2; Pulpotomy with MTA	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and radiographic evaluation	The children will be recalled for postoperative clinical and radiographic assessment at the following intervals: 3, 6, 12 months the treatment will be considered successful if none of the following clinical or radiographic findings is present: Clinical criteria: pain; tenderness to palpation or percussion; gingival swelling or sinus tract; purulent exudate expressed from the gingival margin; abnormal tooth mobility Radiographic criteria: periapical radiolucency; widening in peridontal ligament space	2 years follow up

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 526_1 /11/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No