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

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ClinicalTrials.gov Identifier: NCT05928858
Recruitment Status : Not yet recruiting
First Posted : July 3, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
Aya Adel Abd El-Hafez Osman Hamza, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Indirect Pulp Capping Drug: Premixed Bio-ceramic MTA Drug: Calcium hydroxide Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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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 Name: 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 Name: Dycal, Hydcal


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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. 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)


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05928858


Contacts
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Contact: Aya Ad Hamza, Phd 01062315566 aya.adel@dentistry.cu.edu.eg
Contact: Sara Ah Mahmoud, Professor

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Aya Ad Hamza, Phd Cairo University
More Information
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Responsible Party: Aya Adel Abd El-Hafez Osman Hamza, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT05928858    
Other Study ID Numbers: 14422022585603
First Posted: July 3, 2023    Key Record Dates
Last Update Posted: August 1, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD can be shared with citation to the investigator but not personal data of the patients to protect confidentiality.

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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
Keywords provided by Aya Adel Abd El-Hafez Osman Hamza, Cairo University:
neoputty
premixed bioceramic MTA
young permanent teeth
calcium hydroxide
Additional relevant MeSH terms:
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Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs