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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Other: Adult full pulpotomy procedure

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed A. Yahia, BSc; Phone Number: +201273892231; Email: mohamed.de2016@gmail.com
• Study Contact Backup: Name: motaz M. Elsadat, PhD; Phone Number: +201064808605; Email: motazelsadat@azhar.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11751
    • Recruiting
    • Faculty of Dental Medicine, Al-Azhar University
    • Contact: Moataz A Alkhawas, Professor; Phone Number: +201001189085; Email: moataz-bellahalkhawas.209@azhar.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Postgraduate operator with magnification	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.
Experimental: Postgraduate operator without magnification	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.
Experimental: Undergraduate operator with magnification	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.
Experimental: Undergraduate operator without magnification	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately, 1, 3, 6 and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	The postoperative pain will be measured by the modified Verbal Descriptor Scale.	Immediately, 24, 48, 72 hours and 7 days

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 20, 2024
• First Submitted That Met QC Criteria: January 20, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Irreversible pulpitis; Pulpotomy; Magnification; Clinical experience
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: 874/3036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No