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Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol

Sponsor
Sarah Abdelbar Mahmoud (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05314842
Collaborator
(none)
40
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Primary outcome:

Soft-tissue pathology

  • Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.

  • Sinus tract or fistula will be assessed through visual examination by the operator

Secondary outcomes:

  1. Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror

  2. mobility will be assessed through the back of two mirrors

  3. radiographic assessments:- for any radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).

clinical assessment on every recall visit during the 3-, 6-, and 12-month follow-up period.

• These radiographic assessments will be performed as baseline data at the first visit following the operating procedure, as well as at 3, 6, and 12 months after the baseline.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical and Radiographic Evaluation of Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol Among a Group of Egyptian Children: A Pilot Study.
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control group

the group that have caries in primary molars and treat them with formocresol

Drug: Formocresol
dressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars
Experimental: experimental group

the group that have caries in primary molars and treat them with premixed bioceramic MTA

Drug: Premixed bioceramic MTA
dressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars
Other Names:
  • Neoputty

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Soft-tissue pathology [at 0 day]

      Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)

    2. Soft-tissue pathology [at 3 month]

      Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)

    3. Soft-tissue pathology [at 6 month]

      Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)

    4. Soft-tissue pathology [at 1 year]

      Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. -Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)

    Secondary Outcome Measures

    1. • Pain to the percussion [at 0 day]

      will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent)

    2. • Pain to the percussion [at 3 month]

      will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent)

    3. • Pain to the percussion [at 6 month]

      will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent)

    4. • Pain to the percussion [at 1 year]

      will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent)

    5. mobility [at 0 day]

      • Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades

    6. mobility [at 3 month]

      • Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades

    7. mobility [at 6 month]

      • Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades

    8. mobility [at 1 year]

      • Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades

    9. radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). [at 0 day]

      Binary (present or absent)

    10. radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). [at 3 month]

      Binary (present or absent)

    11. radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). [at 6 month]

      Binary (present or absent)

    12. radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). [at 1 year]

      Binary (present or absent)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Medically fit and cooperative children.

    • Pediatric patients aged 4-6 years.

    • A deep carious lesion in vital primary molars.

    • Absence of clinical signs and symptoms of pulpal exposure.

    • Absence of radiographic signs and symptoms of people degeneration.

    • Positive parental informed consent.

    Exclusion Criteria:

    Uncooperative children.

    • Medically compromised children.

    • Presence of clinical signs and symptoms of pulpal exposure.

    • Presence of radiographic signs and symptoms of pulp degeneration.

    • Physiologic root resorption more than one-third.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sarah Abdelbar Mahmoud

    Investigators

    • Study Chair: ahmed m Elkhadem, Ass.Prof, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sarah Abdelbar Mahmoud, principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05314842
    Other Study ID Numbers:
    • 203
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    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

    Study Results

    No Results Posted as of Apr 6, 2022