The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth

Irreversible Pulpitis Clinical Trial

Official title:

The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231290
• Other study ID #: 874/3036
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

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