The Efficacy of Laser in Root Canal Disinfection

Pulp Necroses Clinical Trial

Official title:

The Efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in Root Canal Disinfection: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05964686
• Other study ID #: FDASU-Rec ID 041908
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2023
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Granuloma
• Necrosis
• Pulp and Periapical Tissue Disease
• Pulp Necroses

Intervention

Combination Product:
• Conventional group (NaOCl/EDTA)
conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA
• Dual laser group (Er,Cr:YSGG/Diode):
Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection
• Combined group (EDTA/Diode):
17% EDTA was used to remove smear layer followed by diode laser for disinfection

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Abbassia

Sponsors (2)

Lead Sponsor	Collaborator
Future University in Egypt	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative microbiological analysis	aerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).; anaerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).	baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]