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

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05020223
• Collaborator: (none)
• Enrollment: 450
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Deep Caries	Other: Vital pulp therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Sucess of Pulpotomy, Direct Pulp Capping and Indirect Pulp Capping Modalities Using MTA in Primary Teeth (2 Years Follow up)
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tenderness [2 years]

   Precence or abscence

2. Abcess [2 years]

   Precence or abscence

3. Fistula [2 years]

   Precence or abscence

4. lamina dura [2 years]

   Intact or distorted

5. Periapical radiographic radiolucency [2 years]

   Precence or abcencs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia University	Minya		Egypt	61111

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahmoud Ahmed Mahmoud, Lecturer, Minia University
• ClinicalTrials.gov Identifier: NCT05020223
• Other Study ID Numbers: 601
• First Posted: Aug 25, 2021
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 25, 2021