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The Efficacy of Laser in Root Canal Disinfection

Primary Purpose

Pulp and Periapical Tissue Disease, Pulp Necroses, Pulp; Granuloma

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Conventional group (NaOCl/EDTA)
Dual laser group (Er,Cr:YSGG/Diode):
Combined group (EDTA/Diode):
Sponsored by
Future University in Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp and Periapical Tissue Disease focused on measuring LASER, Endodontics, canal disinfection

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional group A

Dual laser group B

Combined group C

Arm Description

Outcomes

Primary Outcome Measures

Postoperative pain assessment
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". Pain level assigned to one of 4 categorical scores: No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).

Secondary Outcome Measures

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).

Full Information

First Posted
July 4, 2023
Last Updated
July 25, 2023
Sponsor
Future University in Egypt
Collaborators
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05964686
Brief Title
The Efficacy of Laser in Root Canal Disinfection
Official Title
The Efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in Root Canal Disinfection: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt
Collaborators
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on post operative pain and bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain and 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 Each patient is given pain scale chart Numeric Rating Scale (NRS) to record his/her pain level before any endodontic treatment. 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
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 post operative pain and bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain and 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 Each patient will be given pain scale chart (NRS scale) to record his/her pain level before any endodontic treatment. 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. Patients are asked to mark on a numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity at 6, 12, 24, 48, 72 hours, and 7 days after the procedure 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp and Periapical Tissue Disease, Pulp Necroses, Pulp; Granuloma
Keywords
LASER, Endodontics, canal disinfection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional group A
Arm Type
Active Comparator
Arm Title
Dual laser group B
Arm Type
Experimental
Arm Title
Combined group C
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
Conventional group (NaOCl/EDTA)
Intervention Description
conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA
Intervention Type
Combination Product
Intervention Name(s)
Dual laser group (Er,Cr:YSGG/Diode):
Intervention Description
Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection
Intervention Type
Combination Product
Intervention Name(s)
Combined group (EDTA/Diode):
Intervention Description
17% EDTA was used to remove smear layer followed by diode laser for disinfection
Primary Outcome Measure Information:
Title
Postoperative pain assessment
Description
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". Pain level assigned to one of 4 categorical scores: No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Time Frame
post operative pain will be assessed by calculating median and mean values of pain scores recorded by the patients after 6, 12, 24, 48, 72 hours, and up to 7 days after the procedure
Secondary Outcome Measure Information:
Title
Quantitative microbiological analysis
Description
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).
Time Frame
baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Abbassia
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

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The Efficacy of Laser in Root Canal Disinfection

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