NCT06129643

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. Forty-five 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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

November 8, 2023

Last Update Submit

March 9, 2026

Conditions

Pulp NecrosesApical PeriodontitisPulp Disease, Dental

Keywords

laser in endodonticspost-operative pain

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (3)

Conventional group A

ACTIVE COMPARATOR
Drug: Conventional group

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

EXPERIMENTAL
Device: Dual laser group

Combined group (EDTA/Diode):

EXPERIMENTAL
Combination Product: Combined group

Interventions

Dual laser groupDEVICE

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

Also known as: (Er,Cr:YSGG/Diode)
Dual laser group (Er,Cr:YSGG/Diode)
Conventional groupDRUG

conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

Also known as: (NaOCl/EDTA)
Conventional group A
Combined groupCOMBINATION_PRODUCT

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

Also known as: (EDTA/Diode)
Combined group (EDTA/Diode):

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 11566, Egypt

Location

MeSH Terms

Conditions

Dental Pulp NecrosisPeriapical PeriodontitisDental Pulp DiseasesPain, Postoperative

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsPeriapical DiseasesJaw DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

January 1, 2022

Primary Completion

October 30, 2022

Study Completion

February 1, 2023

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

EG(1)