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

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06129643
• Other study ID #: FDASU-Rec ID 041909
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: November 2023
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Dental Pulp Diseases
• Dental Pulp Necrosis
• Necrosis
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis
• Pulp Disease, Dental
• Pulp Necroses
• Stomatognathic Diseases

Intervention

Drug:
• Conventional group
conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

Device:
• Dual laser group
Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection

Combination Product:
• Combined group
17% EDTA was used to remove smear layer followed by diode laser for disinfection

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Abbassia

Sponsors (2)

Lead Sponsor	Collaborator
Future University in Egypt	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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