Clinical trial NCT04735120: Laser Activation in Reducing Pain During and After Root Canal Treatment for Painful Lower Molar Teeth.
Official title: Effect of Laser Activation on the Intraoperative and Post-treatment Pain in Single Visit Root Canal Treatment for Mandibular Molar Teeth With Acute Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decayed Teeth
Lead sponsor: CSI College of Dental Sciences and Research, Madurai
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: AIM : To assess the intraoperative and postoperative pain incidence for single visit root canal treatment for mandibular molar teeth with acute irreversible pulpitis following laser activation.

MATERIALS AND METHODS: The study will account the patients who are referred to the Department of Endodontics,both male and female patients,with pain due to acute irreversible pulpitis from carious mandibular first and second molar teeth requiring root canal treatment. Subjects of age 13 to 70 years who met the inclusion criteria and responded positively to cold test will be included in the study.

Single visit root canal treatment with 2.5 mL of 2% lignocaine containing 1:80,000 adrenaline for an inferior alveolar block injection will be administered for each individual. After achieving anesthesia, patients who exhibit pain following access opening will be subjected to diode laser application on the pulp canal orifices. With regard to intraoperative pain, pre laser and post laser intraoperative pain incidence will be recorded. Once when the intraoperative pain incidence is reduced, patients will be reassessed for the need of additional anesthesia. If fully anesthetised, root canal procedure will be completed. Preoperative, intraoperative( before and laser application) pulse rate will also be measured. The levels of preoperative and post-operative pain at 24 hrs and 48 hrs for each patient will be recorded using a 10-point visual analog scale (VAS).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in intraoperative pain measured using visual analog scale during root canal treatment following laser application
timeFrame: procedure (during root canal treatment)
Secondary outcomes:
measure: Change in postoperative pain measured using visual analog scale after root canal treatment
timeFrame: 48 hours
Other outcomes:
Locations:
city: Madurai
country: India
facility: Csi College of Dental Sciences and Research
Study officials:
References: