Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis

NCT ID: NCT05427851

Last Updated: 2022-06-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2022-09-01

Brief Summary

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Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed.

Detailed Description

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For each patient, a pulpotomy procedure is done. Group I (n=12) pulpotomy is performed and hemostasis is achieved by applying NaOCl, then the radicular pulp is covered with Platelet Rich Fibrin (PRF) and capped with Biodentine, Group II (n=12) pulpotomy is done as in group I and hemostasis is achieved using diode laser and remaining pulp is capped with Biodentine, Group III (n=12) pulpotomy is performed and hemostasis is achieved as in group II then radicular pulp is covered with PRF then capped with Biodentine, The teeth are then restored with Glass ionomer cement followed by composite restoration. Pain is recorded every 24 hours for 7 days after intervention. Clinical and radiographic follow-up are done at 1,3,6,9 and 12 months. Cone beam computed tomography (CBCT) is done immediate postoperative and will be used for the assessment of the outcome of the pulpotomy procedure at the end of the study period.

Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group I: Platelet rich Fibrin (PRF) and Biodentine

Group Type EXPERIMENTAL

pulpotomy

Intervention Type PROCEDURE

coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material

Group II: Diode Laser and Biodentine

Group Type EXPERIMENTAL

pulpotomy

Intervention Type PROCEDURE

coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material

Diode laser - fonalaser

Intervention Type DEVICE

diode laser beam application

Group III: Diode laser + PRF + Biodentine

Group Type EXPERIMENTAL

pulpotomy

Intervention Type PROCEDURE

coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material

Diode laser - fonalaser

Intervention Type DEVICE

diode laser beam application

Interventions

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pulpotomy

coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material

Intervention Type PROCEDURE

Diode laser - fonalaser

diode laser beam application

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients between 18 and 40 years of age.
2. Deep caries in a permanent lower molar with mature roots.
3. Clinical diagnosis of symptomatic irreversible pulpitis
4. No signs of pulpal necrosis including sinus tract or swelling.
5. Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.
6. The tooth is restorable.

Exclusion Criteria

1. Patients with systemic disease.
2. Negative response to cold testing.
3. Presence of sinus tract or swelling.
4. No pulp exposure after caries excavation.
5. Bleeding could not be controlled
6. Absence of bleeding from any of the canals.
7. Teeth with radiographic signs of internal resorption.
8. Pulpal calcifications.
9. Non-restorable teeth
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raef A sherif, PhD

Role: STUDY_DIRECTOR

Professor of Endodontics, Faculty of Dentistry, Alexandria University

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Darinemamdouh

Identifier Type: -

Identifier Source: org_study_id

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