Post-operative Pain After Laser Root Canal Treatment of Necrotic Teeth With Apical Periodontitis

Post-operative Pain After Laser Root Canal Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial

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.

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 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.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis; Pulp Disease, Dental; Pulp Necroses
• Intervention / Treatment: Drug: Conventional group; Device: Dual laser group; Combination product: Combined group

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.

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 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 11566
      • ain shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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, the vulnerable group including pregnant females, mentally or physically disabled individuals. and technical difficulties during root canal treatment such as; curved roots, broken files, over instrumentation, overfilling or incomplete filling.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional group A	Drug: Conventional group; conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA; Other Names: (NaOCl/EDTA)
Experimental: Dual laser group (Er,Cr:YSGG/Diode)	Device: Dual laser group; Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection; Other Names: (Er,Cr:YSGG/Diode)
Experimental: Combined group (EDTA/Diode):	Combination product: Combined group; 17% EDTA was used to remove smear layer followed by diode laser for disinfection; Other Names: (EDTA/Diode)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain assessment	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).	Measure changes in post-operative pain 6 hours after intervention in the three groups using NRS
Postoperative pain assessment	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).	Measure changes in post-operative pain 12 hours after intervention in the three groups using NRS
Postoperative pain assessment	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).	Measure changes in post-operative pain 24 hours after intervention in the three groups using NRS
Postoperative pain assessment	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).	Measure changes in post-operative pain 48 hours after intervention in the three groups using NRS
Postoperative pain assessment	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).	Measure changes in post-operative pain 72 hours after intervention in the three groups using NRS
Postoperative pain assessment	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).	Measure changes in post-operative pain up to 7 days after intervention in the three groups using NRS

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Collaborators: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: post-operative pain; laser in endodontics
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Necrosis; Periapical Periodontitis; Dental Pulp Diseases; Dental Pulp Necrosis; Stomatognathic Diseases; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Edetic Acid
• Other Study ID Numbers: FDASU-Rec ID 041909

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No