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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05928858
Collaborator
(none)
40
2
12

Study Details

Study Description

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
  • 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.

Although it has been used for several years, calcium hydroxide usage in vital pulp therapy remains controversial. Some studies have shown that calcium hydroxide bases disintegrate in about 6 months and microleakage takes place through tunnel defects in the tertiary dentine bridge. It also doesn't adhere to dentin, nor promote odontoblast differentiation, and it is cytotoxic in cell culture.

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 and supports healing using the same tri and dicalcium silicate powders as NeoMTA. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. Premixed bioceramic MTA delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical And Radiographic Evaluation Of Premixed Bio-ceramic MTA Versus Calcium Hydroxide In Indirect Pulp Capping Of Young Permanent Molars: A Randomized Controlled Trial
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Pain [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. Soft tissue pathology [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)

    2. Radiographic changes [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. The thickness of newly formed dentin [3,6,9,12 month]

      The thickness of newly formed dentin will be assessed in Mm through Digora software

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 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

    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aya Adel Abd El-Hafez Osman Hamza, Assistant lecturer, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05928858
    Other Study ID Numbers:
    • 14422022585603
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 6, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Assistant lecturer, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 6, 2023