Clinical And Radiographic Evaluation Of Premixed Bio-ceramic MTA In Indirect Pulp Capping Of Young Permanent Molars

NCT05928858 | Unknown Phase 3 FDA Drug

• 1 other identifier: 14422022585603
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study aims to evaluate the clinical and radiographic success of premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars.

Conditions

Indirect Pulp Capping

Keywords

neoputty; premixed bioceramic MTA; young permanent teeth; calcium hydroxide

Outcome Measures

Primary Outcomes (1)

• Immediate Postoperative pain

  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.

  one week

Secondary Outcomes (3)

• The thickness of newly formed dentin

  3,6,9,12 month

• Soft tissue pathology

  3,6,9,12 month

• Radiographic changes

  3,6,9,12 month

Study Arms (2)

Premixed Bio-ceramic MTA

EXPERIMENTAL

Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration

Drug: Premixed Bio-ceramic MTA

Calcium hydroxide

ACTIVE COMPARATOR

Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration

Drug: Calcium hydroxide

Interventions

Premixed Bio-ceramic MTA DRUG

Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration

Also known as: Neoputty

Premixed Bio-ceramic MTA

Calcium hydroxide DRUG

Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration

Also known as: Dycal, Hydcal

Calcium hydroxide

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients who have young permanent molars with deep carious lesions.
• Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
• Permanent molars with no clinical or radiographic signs of pulp necrosis including swelling, fistula, pain on percussion,pathologic tooth mobility, thickening of the periodontal ligament space, radiolucency at the periapical area.

You may not qualify if:

• Medically compromised patients who have systemic disease.
• Uncooperative patients who refuse treatment
• Permanent molars that were previously restored
• Children whose parents or caregivers refuse to participate in the study.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Calcium Hydroxide; Dycal

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Aya Ad Hamza, Phd

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya Ad Hamza, Phd

CONTACT

01062315566; aya.adel@dentistry.cu.edu.eg

Sara Ah Mahmoud, Professor

CONTACT

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

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 3, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share