Comparison of Sucess of Pulpotomy, Direct Pulp Capping and Indirect Pulp Capping Modalities Using MTA in Primary Teeth

Comparison of Sucess of Pulpotomy, Direct Pulp Capping and Indirect Pulp Capping Modalities Using MTA in Primary Teeth (2 Years Follow up)

450 healthy children with primary teeth of deep carious lesions without signs or symptomes of irreverisible pulp damage was selected randompy divoded into 3 groups each of 150 children that inder go vital pulp therapy through pulpotomy,direct pulp capping or indirect pulp capping using MTA as capping material for each modality then followed up for 2 years or more

Study Overview

• Status: Recruiting
• Conditions: Deep Caries
• Intervention / Treatment: Other: Vital pulp therapy

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud A Mahmoud; Phone Number: 01009578837; Email: Mam.dent@gmail.com

Study Locations

• Egypt
  • Minya, Egypt, 61111
    • Recruiting
    • Minia University
    • Contact: Ahmad Elheeny, PhD; Phone Number: 00201005560337; Email: ahmed.elheny@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy children
• Aged from 3 to 10 years old
• Deep cariuos primary tooth

Exclusion Criteria:

• Primary teeth with any signs or syptoms of irreversible pulpitis
• Primary teeth of any signs or symptomes of vitality loss
• Primary teeth near to exfoliation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MTA pulpotomy; Usuing MTA as capping material for cervical pulpotomy as a treatment option for deep carious primary teeth with signs and symptoms of reversible pulpitis in presence of pulp exposure	Other: Vital pulp therapy; Vital pulp therapy different modalities for management of deep carious lesion in primary teeth
EXPERIMENTAL: MTA direct pulp capping; Using MTA as capping material in case of trearment of deep carious primary teeth with signs and symptoms of reversible pulpitis with presence of pulp exposure	Other: Vital pulp therapy; Vital pulp therapy different modalities for management of deep carious lesion in primary teeth
EXPERIMENTAL: MTA indirect pulp capping; Using MTA as indirect capping material for treatment of deep carious primary teeth with signs and symptoms of reversible pulpitis	Other: Vital pulp therapy; Vital pulp therapy different modalities for management of deep carious lesion in primary teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tenderness	Precence or abscence	2 years
Abcess	Precence or abscence	2 years
Fistula	Precence or abscence	2 years
lamina dura	Intact or distorted	2 years
Periapical radiographic radiolucency	Precence or abcencs	2 years

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: August 15, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (ACTUAL): August 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 601

Drug and device information, study documents

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