NCT06231290

Brief Summary

The goal of this interventional randomized clinical trial is to test the effect of magnification and clinical experience of the operator on the success rate of full pulpotomy in mature adult molar teeth. The main questions it aims to answer are:

  • Does the use of magnification raise the success rate of full pulpotomy of mature adult molars?
  • Does the clinical experience of the operator dentist raise the success rate of full pulpotomy of mature adult molars? Participants will be asked to do the following:
  • Receive the pulpotomy treatment of their target molar tooth.
  • Record the pain score in the pain assessment chart.
  • Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target molar tooth. Researchers will evaluate the usage of magnification in performing the pulpotomy procedure of adult molar teeth by postgraduate or undergraduate operators in comparison to performing the same pulpotomy procedure without magnification to see if it raises the overall success rate of pulpotomy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

January 20, 2024

Last Update Submit

May 13, 2024

Conditions

Irreversible Pulpitis

Keywords

PulpotomyMagnificationClinical experienceIrreversible pulpitis

Outcome Measures

Primary Outcomes (1)

  • Clinical and radiographic outcome

    The clinical outcome will be measured by the presence or absence of signs and symptoms. The radiographic outcome will be measured by using the PAI index which is a scale from 1 (best) to 5 (worst).

    Immediately, 1, 3, 6 and 12 months.

Secondary Outcomes (1)

  • Postoperative pain

    Immediately, 24, 48, 72 hours and 7 days

Study Arms (4)

Postgraduate operator with magnification

ACTIVE COMPARATOR
Other: Adult full pulpotomy procedure

Postgraduate operator without magnification

EXPERIMENTAL
Other: Adult full pulpotomy procedure

Undergraduate operator with magnification

EXPERIMENTAL
Other: Adult full pulpotomy procedure

Undergraduate operator without magnification

EXPERIMENTAL
Other: Adult full pulpotomy procedure

Interventions

Adult full pulpotomy procedureOTHER

The adult pulpotomy procedure of mature molars will be carried out with the use of magnification (dental loupes or microscope) in healthy patients. The procedure will be performed either by postgraduate or undergraduate operators.

Postgraduate operator with magnificationPostgraduate operator without magnificationUndergraduate operator with magnificationUndergraduate operator without magnification

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy patients diagnosed with acute irreversible pulpitis related to maxillary or mandibular permanent molar teeth without apical periodontitis.

You may not qualify if:

  • Non-vital teeth.
  • Immature teeth.
  • Presence of swelling or sinus tract.
  • Teeth with mobility grade II or III.
  • Immunocompromised patients.
  • Non-restorable teeth.
  • Teeth with apical periodontitis seen in periapical radiograph.
  • Periodontally affected teeth.
  • Teeth with reversible pulpitis
  • Extensive non-stoppable bleeding more than 6 minutes
  • Teeth with partial necrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine, Al-Azhar University

Cairo, 11751, Egypt

RECRUITING

Central Study Contacts

Mohamed A. Yahia, BSc

CONTACT

+201273892231mohamed.de2016@gmail.com

motaz M. Elsadat, PhD

CONTACT

+201064808605motazelsadat@azhar.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate student

Study Record Dates

First Submitted

January 20, 2024

First Posted

January 30, 2024

Study Start

March 20, 2024

Primary Completion

April 1, 2025

Study Completion

July 1, 2025

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

EG(1)