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Clinical Trials/CTRI/2023/01/048830
CTRI/2023/01/048830Not yet recruitingNot Applicable

Efficacy of Low Level Laser Therapy in the Management of Postoperative Pain after Single Visit Endodontic Treatment in patients with Symptomatic Apical Periodontitis: A Single Blinded Randomized Clinical Trial

Nandhita Murugavel1 site in 1 country58 target enrollmentStarted: January 15, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
58
Locations
1
Primary Endpoint
To evaluate the pain Visual Analogue Scale (VAS) scores preoperatively and

Study Overview

Brief Summary

This study is a randomized, single-blinded, single-center trial evaluating the efficacy of Low Level Laser Therapy in the management of postoperative pain after Single Visit Endodontic Treatment in symptomatic apical periodontitis cases in an older age group. The primary outcome measures of this study are to record and evaluate the pain Visual Analogue Scale scores  preoperatively and postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older individuals treated with single visit endodontic treatment followed by interventional application of low level laser therapy or sham laser, which will be the mock application of the laser.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
40.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients between the age group of 40-65 years.
  • Permanent mandibular premolars and molars having symptomatic irreversible pulpitis with symptomatic apical periodontitis
  • Pre-operative pain VAS score: greater than
  • Tenderness on percussion with percussion VAS score: greater than 4
  • Early or lingering response to cold and EPT pulp sensibility testing 6.

Exclusion Criteria

  • Systemic disorders: Cardiovascular system (CVS) disorders, respiratory disorders, asthma patients, coagulation disorders, thyroid disorders, psychiatric disorders, immunocompromised patients.
  • Medical drug intake: patients who have taken analgesics, corticosteroids, sedatives, muscular relaxants, anti-clotting agents or antibiotics 12 hours prior to the intervention.
  • Pregnant individuals.
  • Radiographically detected large periapical lesions or abscesses, space infections
  • History of previous root canal treatment in the same tooth
  • Periodontally compromised tooth (>grade I mobility, pocket depth >4 mm).

Outcomes

Primary Outcomes

To evaluate the pain Visual Analogue Scale (VAS) scores preoperatively and

Time Frame: To evaluate the pain Visual Analogue Scale (VAS) scores preoperatively and | postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic | Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older | individuals treated with single visit endodontic treatment followed by interventional application of low level laser therapy | or sham laser application.

individuals treated with single visit endodontics followed by interventional application of low level laser therapy

Time Frame: To evaluate the pain Visual Analogue Scale (VAS) scores preoperatively and | postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic | Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older | individuals treated with single visit endodontic treatment followed by interventional application of low level laser therapy | or sham laser application.

postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic

Time Frame: To evaluate the pain Visual Analogue Scale (VAS) scores preoperatively and | postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic | Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older | individuals treated with single visit endodontic treatment followed by interventional application of low level laser therapy | or sham laser application.

or sham laser application.

Time Frame: To evaluate the pain Visual Analogue Scale (VAS) scores preoperatively and | postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic | Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older | individuals treated with single visit endodontic treatment followed by interventional application of low level laser therapy | or sham laser application.

Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older

Time Frame: To evaluate the pain Visual Analogue Scale (VAS) scores preoperatively and | postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic | Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older | individuals treated with single visit endodontic treatment followed by interventional application of low level laser therapy | or sham laser application.

Secondary Outcomes

  • Pre-operative or baseline percussion VAS scores will also be compared with 7th(day percussion VAS score.)

Investigators

Sponsor
Nandhita Murugavel
Sponsor Class
Other [self]

Study Sites (1)

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