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

July 28, 2023 updated by: Aya Adel Abd El-Hafez Osman Hamza, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sara Ah Mahmoud, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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
Other Names:
  • Neoputty
Active Comparator: 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
Drug: 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
Other Names:
  • Dycal, Hydcal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue pathology
Time Frame: 3,6,9,12 month
Swelling, sinus tract, fistula, mobility and pain on percussion will be assessed by clinical examination either present or not (binary)
3,6,9,12 month
Radiographic changes
Time Frame: 3,6,9,12 month
Radiolucency at the periapical or furcation area and Internal or external root resorption will be assessed through a digital periapical intraoral radiograph either present or not ( Binary)
3,6,9,12 month
The thickness of newly formed dentin
Time Frame: 3,6,9,12 month
The thickness of newly formed dentin will be assessed in Mm through Digora software
3,6,9,12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Aya Ad Hamza, Phd, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 24, 2023

First Submitted That Met QC Criteria

June 24, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14422022585603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD can be shared with citation to the investigator but not personal data of the patients to protect confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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