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

Not Applicable

Recruiting

• Conditions: Irreversible Pulpitis
• Interventions: Other: Adult full pulpotomy procedure

• Registration Number: NCT06231290
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-20
• Study First Posted: 2024-01-30
• Study Start: 2024-03-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-04
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postgraduate operator with magnification	Adult full pulpotomy procedure	-
Postgraduate operator without magnification	Adult full pulpotomy procedure	-
Undergraduate operator with magnification	Adult full pulpotomy procedure	-
Undergraduate operator without magnification	Adult full pulpotomy procedure	-

Primary Outcome Measures

Name	Time	Method
Clinical and radiographic outcome	Immediately, 1, 3, 6 and 12 months.	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dental Medicine, Al-Azhar University; 🇪🇬 Cairo, Egypt