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

NCT ID: NCT06129643

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulp Necroses Apical Periodontitis Pulp Disease, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional group A

Group Type ACTIVE_COMPARATOR

Conventional group

Intervention Type DRUG

conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

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

Group Type EXPERIMENTAL

Dual laser group

Intervention Type DEVICE

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

Combined group (EDTA/Diode):

Group Type EXPERIMENTAL

Combined group

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Conventional group

conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

Intervention Type DRUG

Dual laser group

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

Intervention Type DEVICE

Combined group

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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(NaOCl/EDTA) (Er,Cr:YSGG/Diode) (EDTA/Diode)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role collaborator

Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Sara Zakaria Fahim

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, Abbassia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FDASU-Rec ID 041909

Identifier Type: -

Identifier Source: org_study_id