A Clinical and Radiographic Evaluation of Low-Level Diode Laser Full Pulpotomy in Vital Permanent Teeth

Not Applicable

Completed

• Conditions: Irreversible Pulpitis; Endodontic Inflammation
• Interventions: Device: diode laser pulpotomy; Other: traditional pulpotomy

• Registration Number: NCT06176378
• Lead Sponsor: Al-Azhar University

Brief Summary

In this study, patients with symptoms of irreversible pulpitis in mature permanent molars were treated with two pulpotomies techniques after random allocation in either 2 groups: Diode laser pulpotomy and traditional pulpotomy using bioactive materials (retro mineral trioxide aggregate ) with each group.The null hypothesis of the study was there would be no difference in success rate between Diode laser and traditional methods of adult pulpotomy .

Detailed Description

In this study, 40 patients with symptoms of irreversible pulpitis in mature permanent 1st and 2nd molars were treated with two pulpotomy techniques after random allocation in either 2 groups: traditional pulpotomy and low-level diode laser pulpotomy. The pulp in each group was capped with Retro MTA . In the traditional pulpotomy group, the coronal pulp was removed by the traditional method while in the low-level diode laser pulpotomy group, the radicular pulp was biostimulated using low-level diode laser beam with parameters (970nm, power .5Watt, duty cycle 50%, and frequency 5H) 10 sec for each pulp stump in non-contact mode. After that, the capping material was prepared as manufacturer's instructions and applied over the pulp stamp, the final restoration was then placed in both groups. Patients were followed up after 6, 12, and 18 months to evaluate success and failure.

Study Timeline

• Study Start: 2020-10-12
• Primary Completion: 2023-03-14
• Study Completion: 2023-03-14
• Status Verified: 2023-12
• Study First Submitted: 2023-12-10
• Study First Submitted QC: 2023-12-10
• Study First Posted: 2023-12-19
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diode laser Pulpotomy procedures	diode laser pulpotomy	in the low-level diode laser pulpotomy group, the radicular pulp was biostimulated using low-level diode laser before application of capping material
Traditional Pulpotomy procedures	traditional pulpotomy	In the traditional pulpotomy group, the coronal pulp was removed by the traditional method the the capping material applied

Primary Outcome Measures

Name	Time	Method
Assessment of success or failure	(T1): 1 week postoperative, (T2): after 6 months, (T3): after 12 months, and (T4) after 18 months.	Assessment of success or failure was done using the technique described by Galeni et al; Treatment was considered successful if the patient's final restoration was intact and the patient demonstrated no clinical symptoms (pain (spontaneous or on chewing), swelling, or sinus tract), and had a periapical index score of 1.; • Treatment was considered uncertain if the patient's final restoration was intact, and the patient demonstrated no clinical symptoms (pain (spontaneous or on chewing), swelling, or sinus tract), and a PAI score of 2.; •; Treatment was considered a failure in the following situations: 1. Any case in which the final restoration was not intact. Irrelevant clinical and radiographic symptoms.; 2. Any case in which the final restoration was intact and the patient demonstrated clinical symptoms. Irrelevant of PAI score.; 3. Any case in which the final restoration was intact and the patient had a PAI score of 3 or above. Irrelevant of clinical symptoms.

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Egypt