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pulpotomy: Outcome of Full Pulpotomy Using Calcium Silicate Based Materials

Sponsor
Jordan University of Science and Technology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04345263
Collaborator
(none)
150
Enrollment
2
Locations
3
Arms
68
Anticipated Duration (Months)
75
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years.

Condition or Disease Intervention/Treatment Phase
  • Procedure: MTA pulpotomy
 N/A

Detailed Description

  • The target sample size is 150 patients medically fit, having vital teeth with carious pulp exposure and complaining of pain.

  • The patients tooth will receive full pulpotomy under aseptic conditions and it will be randomly assigned to one of 3 calcium silicate based materials namely, (Mineral trioxide Aggregate (MTA), Biodentine, and Bioceramic for capping the full pulpotomy followed by resin composite restoration.

  • Follow up for pain levels will be done during the first week.

  • clinical and radiographic examination will be done at 6 months, 1 year and yearly up to 5 years.

  • Success of the procedure includes absence of clinical signs and symptoms, with absence of pathology in the root and periapex on periapical radiographs.

  • The 3 materials will be compared in terms of clinical and radiographic outcomes.

  • demographic data of the three groups will be also compared

  • predictive factors of success will be also analyzed

  • tooth color changes will be also measured using vita easy shade and will compared between the groups at 6 months and 1 year.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Patient unaware of the material to be used, care provider will be given the material after performing full pulpotomy . Tooth crown will be masked during assessment of radiographs
Primary Purpose:
Treatment
Official Title:
Outcome of Full Pulpotomy in Permanent Teeth With Carious Pulp Exposure, a Randomized Clinical Trial
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
May 2, 2018
Anticipated Study Completion Date :
May 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: MTA pulpotomy

Tooth will receive MTA & resin composite restoration

Procedure: MTA pulpotomy
Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration
Other Names:
  • Biodentine pulpotomy and Bioceramic pulpotomy

    		•
    Active Comparator: Biodentine pulpotomy

    Tooth will receive Biodentine & resin composite restoration

    Procedure: MTA pulpotomy
    Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration
    Other Names:
  • Biodentine pulpotomy and Bioceramic pulpotomy

    		•
    Active Comparator: Bioceramic pulpotomy

    Tooth will receive Bioceramic & resin composite restoration

    Procedure: MTA pulpotomy
    Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration
    Other Names:
  • Biodentine pulpotomy and Bioceramic pulpotomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Degree of pain relief after treatment compared to preoperative pain level [1 week]

      Absence of symptoms or significant pain reduction within the first week after treatment as measured on a numerical scale from 0 to 10 where zero means no pain and 10 is the most sever pain. Visual analogue scale will be also used.

    Secondary Outcome Measures

    1. Radiographic normalcy [1 year and yearly up to 5 years]

      Absence of pathology in the root and the bone surrounding the apex

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Mature permanent tooth with carious lesion exposing the pulp,

    • Positive response to cold test

    • Clinical Diagnosis of reversible or irreversible pulpitis

    • Restorable tooth by direct restoration or crown

    • Healthy patient

    Exclusion Criteria:

    • Non vital teeth

    • Teeth without pulp exposure

    • Inability to achieve hemostasis within 10 min after pulpotomy

    • Non restorable teeth or teeth that require post and core restoration

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dental teaching centre Faculty Of Dentistry IRbid Jordan 21110
    2 Jordan University of science and technology Irbid Jordan 22110

    Sponsors and Collaborators

    • Jordan University of Science and Technology

    Investigators

    • Study Chair: Nessrin Taha, DCD, Jordan University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jordan University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT04345263
    Other Study ID Numbers:
    • 503/2017
    First Posted:
    Apr 14, 2020
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jordan University of Science and Technology
    teeth, caries, pulpotomy, MTA, biodentine, bioceramic
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Sep 22, 2021