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

NCT ID: NCT06176378

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2023-03-14

Brief Summary

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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

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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.

Conditions

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Irreversible Pulpitis Endodontic Inflammation

Keywords

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Full pulpotomy Low-level Diode Laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Traditional Pulpotomy procedures

In the traditional pulpotomy group, the coronal pulp was removed by the traditional method the the capping material applied

Group Type EXPERIMENTAL

traditional pulpotomy

Intervention Type OTHER

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,

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

Group Type EXPERIMENTAL

diode laser pulpotomy

Intervention Type DEVICE

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,

Interventions

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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,

Intervention Type OTHER

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,

Intervention Type DEVICE

Other Intervention Names

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full pulpotomy laser biostimulation

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Ehab Ali Elsayed

principal investigator/Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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153/166

Identifier Type: -

Identifier Source: org_study_id