Patient Reported Outcomes and Associated Factors Followin... | NCT07192146

Studies
Patient Reported Outcomes and Associated Factors Following Endodontic Emergency Treatment

NCT07192146

Sponsor

Chulalongkorn University

Status

Recruiting

Last Update Posted

Sep 25, 2025Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Moderate to Severe Endodontic Pain

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 17, 2023Actual

Primary Completion Date

Apr 28, 2025Actual

Completion Date

Oct 2025Estimated

First Submitted Date

Jul 20, 2025

First Submission Date that Met QC Criteria

Sep 21, 2025

First Posted Date

Sep 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2025

Last Update Posted Date

Sep 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to analyze the improvement of postoperative pain and Oral Health-Related Quality of Life (OHRQoL) following endodontic emergency treatment, as well as the contributing factors affecting the change including age, gender, tooth type, dental arch, pulpal status, percussion pain, radiographic evidence of periapical lesions, type of emergency treatment (pulpotomy / partial pulpectomy / complete pulpectomy), and occlusal adjustment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain	Higher scores mean a worse outcome.	From enrollment to the end of treatment at 2 years

Secondary Outcomes

Measure	Description	Time Frame
Oral health-related quality of life	Higher scores mean a worse outcome.	From enrollment to the end of treatment at 2 years

Other Outcomes

Measure	Description	Time Frame
Prognostic factors associated with the improvement of postoperative pain		From enrollment to the end of treatment at 2 years
Prognostic factors associated with the improvement of oral health-related quality of life		From enrollment to the end of treatment at 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Presence of moderate to severe pain as measured by a Numerical Rating Scale (NRS) score ≥ 4
Pain of endodontic origin confirmed through clinical and/or radiographic examination

Exclusion Criteria:

Refused or were unable to provide informed consent or complete the questionnaire
Were currently or recently taking immunosuppressive agents, long-term anti-inflammatory medications, or antibiotics
Had non-endodontic or mixed-origin pain
Had already initiated endodontic treatment on the affected tooth

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergo endodontic emergency treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pantira Thep-akrapong	Contact	66813730370		pantira.mew@gmail.com
Chanakarn Sinsareekul	Contact	66832759760		chanakarn.si@chula.ac.th

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry, Chulalongkorn University	Recruiting	Bangkok		10330	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided