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

Sponsor

Future University in Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT06129643

Collaborator

Ain Shams University (Other)

Enrollment

Location

Arms

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Pulp Necroses Apical Periodontitis Pulp Disease, Dental	Drug: Conventional group Device: Dual laser group Combination Product: Combined group	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Oct 30, 2022

Actual Study Completion Date :

Feb 1, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Postoperative pain assessment [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 [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 [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 [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 [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).
Postoperative pain assessment [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.