Clinical and Radiographic Evaluation of Bioceramic Putty MTA Versus MTA in Pulpotomy of Immature Permanent Molars

NCT06219824 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 14422022599195
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to evaluate the clinical and radiographic success of bioceramics putty MTA versus MTA in the pulpotomy of immature permanent molars The main question it aims to answer is: Will the biocermaics putty MTA have higher clinical and radiographic success rates than MTA in pulpotomy of immature permanent molars?

Conditions

Pulpotomy; Deep Caries

Keywords

Immature permanent molars,; young permenent molars; pulpotomy; vital pulp therapy; deep caries; Putty MTA; bioceramic MTA

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Immediate Postoperative pain \[ Time Frame: one week) post operative pain by Verbal analogue scale.It is a 10 cm long horizontal line with points labeled from 0 to 10 where (0) indicates no pain, (1-3) mild pain, (4-6) moderate pain, and (7-10) severe pain.

  24hrs, 1 week

Secondary Outcomes (1)

• Secondary outcome

  6,12 month

Study Arms (2)

control Group

ACTIVE COMPARATOR

pulpotomy treatment for the young permanent teeth will be done using conventional powder and liquid Mineral Trioxide Aggregate followed by Glassionomer restoration and stainless steel crown

Drug: Conventional MTA

Experimental

EXPERIMENTAL

pulpotomy treatment for the young permanent teeth will be done using premixed ready for use bioceramic MTA followed by Glassionomer restoration and stainless steel crown

Drug: premixed Bio-ceramic MTA

Interventions

premixed Bio-ceramic MTA DRUG

pulpotomy treatment will be done and the premixed bioceramic MTA will be applied in the pulp chamber

Also known as: well Root MTA

Experimental

Conventional MTA DRUG

pulpotomy treatment will be done and powder and liquid MTA will be mixed and applied in the pulp chamber

Also known as: Pro-root MTA

control Group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged from 6-8 years of both sexes have immature permanent molars
• with deep carious lesions indicated for pulpotomy.
• Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
• Permanent molars without any clinical sign of pulp necrosis including swelling, fistula, pain on percussion, and pathologic tooth mobility.
• Permanent molars without any adverse radiographic findings including thickening of the periodontal ligament space, radiolucency at the interradicular or periapical regions
• permanent molars without internal and external root resorption, or calcification in pulp tissue.

You may not qualify if:

• Medically compromised patients who have systemic disease.
• Uncooperative patients who refuse treatment.
• Permanent molars that were previously restored.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Central Study Contacts

Marwa Ad Hussien, MSD

CONTACT

01222156972; marwa.hussien@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Pediatric Dentistry, Faculty of Dentistry, October University for Modern Sciences and Arts

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 23, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 30, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)