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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06231290
Other study ID # 874/3036
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2024
Est. completion date July 2025

Study information

Verified date May 2024
Source Al-Azhar University
Contact Mohamed A. Yahia, BSc
Phone +201273892231
Email mohamed.de2016@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date July 2025
Est. primary completion date April 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Healthy patients diagnosed with acute irreversible pulpitis related to maxillary or mandibular permanent molar teeth without apical periodontitis. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Adult full pulpotomy procedure
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.

Locations

Country Name City State
Egypt Faculty of Dental Medicine, Al-Azhar University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Postoperative pain The postoperative pain will be measured by the modified Verbal Descriptor Scale which is a scale from 0 (best) to 10 (worst). Immediately, 24, 48, 72 hours and 7 days
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