NCT04735120

Brief Summary

Effectiveness of lasers in reducing pain during and after root canal treatment for mandibular molar teeth affected with acute irreversible pulpitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

January 26, 2021

Last Update Submit

February 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in intraoperative pain measured using visual analog scale during root canal treatment following laser application

    Change in pain is assessed in 10 point visual analog scale (VAS) before and after laser application.

    procedure (during root canal treatment)

Secondary Outcomes (1)

  • Change in postoperative pain measured using visual analog scale after root canal treatment

    48 hours

Study Arms (1)

Laser to reduce pain intraoperatively and post operatively

EXPERIMENTAL

Diode lasers are used to assess its efficacy in reducing intraoperative and postoperative pain following root canal treatment in mandibular molar teeth with acute irreversible pulpitis

Device: iLASE DIODE LASERS

Interventions

940nm diode laser with 1.5 watts activated in a continuous mode and applied on to the canal orifices during root canal treatment to reduce intraoperative pain and further its effect on post operative pain is assessed

Laser to reduce pain intraoperatively and post operatively

Eligibility Criteria

Age13 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with painful mandibular molar teeth due to caries with no history of medication intake before 7 days prior to root canal treatment
  • Patients who respond exaggerated pain with or without lingering response on cold test

You may not qualify if:

  • Patients who do not have pain upon access opening following local anesthesia administration
  • Teeth with poor periodontal or restorative prognosis,
  • Patients with serious systemic ailments or conditions hindering single visit root canal treatment
  • patients not willing to participate in the post operative recall evaluation
  • Teeth with anatomic variations and
  • Allergic patients are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Csi College of Dental Sciences and Research

Madurai, 625001, India

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 2, 2021

Study Start

February 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2022

Last Updated

February 4, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations