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

December 19, 2023 updated by: Ehab Ali Elsayed, Al-Azhar University
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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11651
        • Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • permanent 1st and 2nd molar
  • irreversible pulpitis
  • restorable

Exclusion criteria:

  • Non-restorable teeth.
  • Teeth with buccal restoration.
  • Non-vital teeth that are not responsive to thermal stimuli or electric pulp test.
  • Presence of swelling or sinus tracts.
  • Teeth which showed sensitivity to percussion.
  • Teeth with grade Ⅱ and Ⅲ mobility.
  • Teeth with immature apices.
  • Teeth with internal or external resorption or teeth with periapical pathosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Traditional Pulpotomy procedures
In the traditional pulpotomy group, the coronal pulp was removed by the traditional method the the capping material applied
Other: traditional pulpotomy
After complete deroofing, the coronal pulp was amputated to the level of the orifice using a high-speed size #2 round bur followed by rinsing the pulp chamber thoroughly with 5ml 0.9% saline solution.Hemostasis was then achieved by placing a sterile cotton pellet moistened with saline in the access cavity for 6 min.Retro MTA capping material was then applied,
Other Names:
  • full pulpotomy
Experimental: Diode laser Pulpotomy procedures
in the low-level diode laser pulpotomy group, the radicular pulp was biostimulated using low-level diode laser before application of capping material
Device: diode laser pulpotomy
after establishing hemostasis, low-level laser energy at (970nm, power .5W, duty cycle 50%, and frequency 5H) was applied to each pulp stump for 10 sec. through 320 microns optical fiber tip . The laser was used in pulsed non-contact mode at the level of the occlusal surface of the tooth.Retro MTA capping material was then applied,
Other Names:
  • laser biostimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of success or failure
Time Frame: (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.
(T1): 1 week postoperative, (T2): after 6 months, (T3): after 12 months, and (T4) after 18 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2020

Primary Completion (Actual)

March 14, 2023

Study Completion (Actual)

March 14, 2023

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 10, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 153/166

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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