The Efficacy of Laser in Root Canal Disinfection

Sponsor

Future University in Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT05964686

Collaborator

Ain Shams University (Other)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulp and Periapical Tissue Disease Pulp Necroses Pulp; Granuloma	Combination Product: Conventional group (NaOCl/EDTA) Combination Product: Dual laser group (Er,Cr:YSGG/Diode): Combination Product: Combined group (EDTA/Diode):	Phase 2

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Sep 30, 2022

Actual Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional group A	Combination Product: Conventional group (NaOCl/EDTA) conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA
Experimental: Dual laser group B	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
Experimental: Combined group C	Combination Product: Combined group (EDTA/Diode): 17% EDTA was used to remove smear layer followed by diode laser for disinfection

Arm

Intervention/Treatment

Active Comparator: Conventional group A

Combination Product: Conventional group (NaOCl/EDTA)

conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

Experimental: Dual laser group B

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

Experimental: Combined group C

Combination Product: Combined group (EDTA/Diode):

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

Outcome Measures

Primary Outcome Measures

Postoperative pain assessment [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]
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 [baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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