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Clinical Trials/NCT06129643
NCT06129643
Completed
Phase 2

Efficacy of 2780 nm Er,Cr:YSGG and 940 nm Diode Lasers in Root Canal Treatment, Part II: Postoperative Pain

Future University in Egypt1 site in 1 country45 target enrollmentJanuary 1, 2022

Overview

Phase
Phase 2
Intervention
Conventional group
Conditions
Pulp Necroses
Sponsor
Future University in Egypt
Enrollment
45
Locations
1
Primary Endpoint
Postoperative pain assessment
Status
Completed
Last Updated
last month

Overview

Brief Summary

The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.

Forty-five 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. All data will be collected, tabulated, summarized, and statistically analyzed.

Detailed Description

Postoperative pain is a common complication following conventional endodontic treatment. According to a systematic review, the frequency of endodontic postoperative pain is between 3% and 58% of patients.Postoperative pain is attributed to chemical, mechanical and microbiological factors. Residual microorganisms remaining due to the complexity of the root canal system and the limited penetration capability of conventional irrigants are directly responsible for Post operative pain The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used. Forty-five 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, tooth isolation, access cavity preparation and final obturation. 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 All data will be collected, tabulated, summarized, and statistically analyzed.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
February 1, 2023
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara Zakaria Fahim

assistant lecturer

Future University in Egypt

Eligibility Criteria

Inclusion Criteria

  • Patients who had asymptomatic, single-rooted maxillary anterior teeth with necrotic pulp and periapical lesion with a periapical index score of 3 or 4
  • Patients complaining of no pain and without fistulous tract
  • Closed apex.
  • Acceptance to participate in the study.

Exclusion Criteria

  • Antibiotic use within the last month, anti-inflammatory analgesic use within the last 5 d, systemic diseases or allergic reactions, calcified canals, root resorption, previous root canal treatment.
  • Periodontal diseases, presence of swelling or fistulous tract.
  • Vulnerable group including pregnant females, mentally or physically disabled individuals. - Technical difficulties during root canal treatment such as; curved roots, broken files, over instrumentation, overfilling or incomplete filling.

Arms & Interventions

Conventional group A

Intervention: Conventional group

Dual laser group (Er,Cr:YSGG/Diode)

Intervention: Dual laser group

Combined group (EDTA/Diode):

Intervention: Combined group

Outcomes

Primary Outcomes

Postoperative pain assessment

Time Frame: Measure changes in post-operative pain up to 7 days after intervention in the three groups using NRS

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).

Postoperative pain assessment

Time Frame: Measure changes in post-operative pain 6 hours after intervention in the three groups using NRS

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).

Postoperative pain assessment

Time Frame: Measure changes in post-operative pain 12 hours after intervention in the three groups using NRS

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).

Postoperative pain assessment

Time Frame: Measure changes in post-operative pain 24 hours after intervention in the three groups using NRS

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).

Postoperative pain assessment

Time Frame: Measure changes in post-operative pain 48 hours after intervention in the three groups using NRS

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).

Postoperative pain assessment

Time Frame: Measure changes in post-operative pain 72 hours after intervention in the three groups using NRS

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).

Study Sites (1)

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