Clinical trial

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

Name

FDASU-Rec ID 041909

Description

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.

Trial arms

Trial start

2022-01-01

Estimated PCD

2022-10-30

Trial end

2023-02-01

Status

Completed

Phase

Early phase I

Treatment

Conventional group

conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

Arms:

Conventional group A

Other names:

(NaOCl/EDTA)

Dual laser group

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

Arms:

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

Other names:

(Er,Cr:YSGG/Diode)

Combined group

17% EDTA was used to remove smear layer followed by diode laser for disinfection

Arms:

Combined group (EDTA/Diode):

Other names:

(EDTA/Diode)

Size

Primary endpoint

Postoperative pain assessment

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

Postoperative pain assessment

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

Postoperative pain assessment

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

Postoperative pain assessment

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

Postoperative pain assessment

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

Postoperative pain assessment

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

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

Updated at

2023-11-24

1 organization

2 products

4 indications

Organization

Future University in Egypt

Product

Indication

Indication

Indication

Indication

Product