NCT06860191

Brief Summary

In this study, the effects of different irrigation agitation methods and different root canal filling sealers on postoperative pain after root canal treatment will be evaluated.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_4

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

Same day

First QC Date

February 1, 2025

Last Update Submit

February 28, 2025

Conditions

Keywords

Cariesapical periodontitisirrigation agitationroot canal sealer

Outcome Measures

Primary Outcomes (1)

  • Pain symptoms of the patients will be evaluated with prepared questionnaires, and periapical lesion healing will be evaluated with periapical radiographs. A visual analog scale will be used to measure the degree of pain.

    Performing clinical and radiographic follow-up and evaluation of the patient.A visual analog scale will be used to measure the degree of pain.

    1-4 months

Study Arms (4)

Ah plus+MDA

EXPERIMENTAL

Ah plus will be used as the root canal sealer and manual dynamic activation will be used for irrigation agitation.

Drug: Root Canal Sealants

Ah plus+PUA

EXPERIMENTAL

Ah plus will be used as the root canal sealer and pasive ultrasonic agitation will be used for irrigation agitation.

Drug: Root Canal Sealants

Neosealer Flo+MDA

EXPERIMENTAL

Neosealer Flo will be used as the root canal sealer and manual dynamic activation will be used for irrigation agitation.

Drug: Root Canal Sealants

Neosealer Flo+PUA

EXPERIMENTAL

Neosealer Flo will be used as the root canal sealer and pasive ultrasonic agitation will be used for irrigation agitation.

Drug: Root Canal Sealants

Interventions

In this study, different irrigation agitation methods and different root canal sealers will be compared.

Ah plus+MDAAh plus+PUANeosealer Flo+MDANeosealer Flo+PUA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60 years who are classified as medically healthy (ASA I or II),
  • Teeth that do not need periodontal and prosthetic treatment, with a periapical index score between 2 and 4,
  • Teeth with single root and canal diagnosed with asymptomatic apical periodontitis,
  • Teeth that respond negatively to electric pulp test (Parkell) or cold test (Endo Ice; Coltene, Altstätten, İsviçre), without pain during percussion and palpation.

You may not qualify if:

  • Teeth with PAI scores lower than 2
  • Patients who had taken analgesics or anti-inflammatory drugs in the last 4 hours
  • Diabetic, immunocompromised, pregnant or history of antibiotic use in the last month or patients receiving antibiotic prophylaxis
  • Teeth with root resorption, immature, severe crown damage, calcified canals, and previous root canal fillings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Root Canal Filling Materials

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

İpek A ERASLAN AKYÜZ

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

February 1, 2025

First Posted

March 5, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

March 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

It was decided that it was appropriate to keep participant information confidential until the study was completed.