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Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04710160
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
15
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.

Condition or Disease Intervention/Treatment Phase
  • Drug: Novel fast-setting calcium silicate cement (Protooth)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Oct 22, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Novel fast setting calcium silicate ( Protooth)

In the form of powder and liquid to be mixed together to form paste.

Drug: Novel fast-setting calcium silicate cement (Protooth)
In form of power and liquid to be mixed together to form a paste.
Other Names:
  • mineral trioxide aggregate (MTA )

    		•
    Experimental: MTA

    In form of powder to be mixed with saline to form paste.

    Drug: Novel fast-setting calcium silicate cement (Protooth)
    In form of power and liquid to be mixed together to form a paste.
    Other Names:
  • mineral trioxide aggregate (MTA )

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS [12 months]

      Post-operative pain following pulpotomy treatment will be measured. A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.

    Secondary Outcome Measures

    1. Radiographic evaluation following the Pulpotomy treatment will be measured [12 months]

      Binary assessment of the radiographs taken after the treatment ( if there is any radiolucent or widening in the lamina sure nor evidence of internal/external pathologic root resorption)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs

    • No allergic reactions recorded in patient history

    • Having primary molar teeth in one jaw, having deep caries and vital pulp.

    • No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule

    • Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test

    • Radiographic criteria:

    • No sign of radiolucency in periapical or furcation area

    • No widening of PDL space or loss of lamina dura continuity

    • No evidence of internal/external pathologic root resorption

    Exclusion Criteria:

    • Lack of informed consent by the child patient's parent

    • Lack of informed consent by the child patient's parent

    • Unable to attend follow-up visits.

    • Refusal of participation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentsitry , Cairo University Cairo El Manial Egypt 11553

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nashwa Ossama Ahmed Elshaer, principle investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04710160
    Other Study ID Numbers:
    • Pedo193
    First Posted:
    Jan 14, 2021
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nashwa Ossama Ahmed Elshaer, principle investigator, Cairo University
    Pulpotomy , Primary molars , Protooth , MTA
    Additional relevant MeSH terms:
    Calcium

    Study Results

    No Results Posted as of Aug 5, 2021