The Efficacy of Laser in Root Canal Disinfection | NCT05964686

Studies
The Efficacy of Laser in Root Canal Disinfection

NCT05964686

Sponsor

Future University in Egypt

Status

Completed

Last Update Posted

Nov 29, 2023Actual

Enrollment

30Actual

Phase

Phase 2

Conditions

Pulp and Periapical Tissue Disease
Pulp Necroses
Pulp; Granuloma

Interventions

Conventional group (NaOCl/EDTA)
Dual laser group (Er,Cr:YSGG/Diode):
Combined group (EDTA/Diode):

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Jul 4, 2023

First Submission Date that Met QC Criteria

Jul 25, 2023

First Posted Date

Jul 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2023

Last Update Posted Date

Nov 29, 2023Actual

Name	Class
Ain Shams University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Conventional group A	Active Comparator	Combination Product: Conventional group (NaOCl/EDTA)
Dual laser group B	Experimental	Combination Product: Dual laser group (Er,Cr:YSGG/Diode):
Combined group C	Experimental	Combination Product: Combined group (EDTA/Diode):

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional group (NaOCl/EDTA)	Combination Product	conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA	Conventional group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003790	Dental Pulp Necrosis
D006099	Granuloma

ID	Term
D003788	Dental Pulp Diseases
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D009336	Necrosis