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Clinical Trials/NCT05928858
NCT05928858
Not yet recruiting
Phase 3

Clinical And Radiographic Evaluation Of Premixed Bio-ceramic Mineral Trioxide Aggregate Versus Calcium Hydroxide In Indirect Pulp Capping Of Young Permanent Molars: A Randomized Controlled Trial

Cairo University0 sites40 target enrollmentSeptember 2023

Overview

Phase
Phase 3
Intervention
Premixed Bio-ceramic MTA
Conditions
Indirect Pulp Capping
Sponsor
Cairo University
Enrollment
40
Primary Endpoint
Immediate Postoperative pain
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Detailed Description

Researchers are still in search of an ideal material for pulp capping, and they evaluated numerous dental materials. For many decades, calcium hydroxide has been the 'gold standard' material for maintaining pulp vitality. Both clinically and histologically, it has been found to produce satisfactory results in indirect and direct pulp capping because it can stimulate the formation of tertiary dentine by the pulp and it has antimicrobial properties. Due to the drawbacks of calcium hydroxide, several materials have been developed, such as NeoPUTTY which is premixed bio-ceramic Mineral Trioxide Aggregate (MTA) that triggers hydroxyapatite. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. It also delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time.

Registry
clinicaltrials.gov
Start Date
September 2023
End Date
September 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aya Adel Abd El-Hafez Osman Hamza

Assistant lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

Premixed Bio-ceramic MTA

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

Intervention: Premixed Bio-ceramic MTA

Calcium hydroxide

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

Intervention: Calcium hydroxide

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Soft tissue pathology(3,6,9,12 month)
  • Radiographic changes(3,6,9,12 month)
  • The thickness of newly formed dentin(3,6,9,12 month)

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