The Efficacy of Laser in Root Canal Disinfection

NCT ID: NCT05964686

Last Updated: 2023-11-29

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

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-30

Brief Summary

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The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.

Thirty patients are equally divided into 3 separate groups :

* Group A (Conventional): 2.5% NaOCL and 17% EDTA.
* Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
* Group C(Combined): saline along with 17% EDTA and diode laser combination Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.

Detailed Description

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The use of lasers in disinfection of the root canal has been recently implemented. Lasers have bactericidal effect, and have deep penetration depth inside the root canal up to 1000 um. Thus, it can be used effectively for disinfection of the root canal system following biomechanical instrumentation reaching areas which were considered before non-reachable.

The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.

Thirty patients are equally divided into 3 separate groups :

* Group A (Conventional): 2.5% NaOCL and 17% EDTA.
* Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
* Group C(Combined): saline along with 17% EDTA and diode laser combination After disinfection, local anesthetic and tooth isolation and access cavity preparation, the first microbial samples (S1) will be collected using 3 sterile paper points and immediately placed inside sterile tubes containing transport medium of thioglycolate, cleaning and shaping with final disinfection protocol will be performed according to the group in which the participant was allocated to. Followed by S2 sample. obturation using warm vertical compaction technique. Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.

Conditions

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Pulp and Periapical Tissue Disease Pulp Necroses Pulp; Granuloma

Keywords

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LASER Endodontics canal disinfection

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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Conventional group A

Group Type ACTIVE_COMPARATOR

Conventional group (NaOCl/EDTA)

Intervention Type COMBINATION_PRODUCT

conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

Dual laser group B

Group Type EXPERIMENTAL

Dual laser group (Er,Cr:YSGG/Diode):

Intervention Type COMBINATION_PRODUCT

Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection

Combined group C

Group Type EXPERIMENTAL

Combined group (EDTA/Diode):

Intervention Type COMBINATION_PRODUCT

17% EDTA was used to remove smear layer followed by diode laser for disinfection

Interventions

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Conventional group (NaOCl/EDTA)

conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

Intervention Type COMBINATION_PRODUCT

Dual laser group (Er,Cr:YSGG/Diode):

Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection

Intervention Type COMBINATION_PRODUCT

Combined group (EDTA/Diode):

17% EDTA was used to remove smear layer followed by diode laser for disinfection

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* • Patients who are medically free.

* Patient's age between 18-35 years.
* One single rooted maxillary anterior tooth with necrotic pulp and asymptomatic apical periodontitis requiring root canal treatment.
* Patients complaining of no pain and without fistulous tract.
* Periapical lesion with a periapical index score of 3 or 4 (Ørstavik, et al. (1986)108
* Closed apex.
* Acceptance to participate in the study.

Exclusion Criteria

* Patients suffering from any systemic disease.
* Patients who had received antibiotics during the last month.
* Patients taking analgesics 12 hours before interventions.
* Patients with history of tobacco usage
* Teeth with vital pulp, calcified canals, and immature or incompletely formed apices.
* Teeth with previous endodontic treatment.
* Non restorable teeth where rubber dam could not be applied.
* Teeth with periodontal pocket more than 3 mm.
* Teeth with greater than grade 1 mobility.
* Teeth with swelling/sinus tract.
* Technical difficulties in the course of root canal treatment for example:

* A tooth with curved roots
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role collaborator

Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Sara Zakaria Fahim

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, Abbassia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FDASU-Rec ID 041908

Identifier Type: -

Identifier Source: org_study_id