NCT03456141

Brief Summary

With a prospective, observational study assess post-surgery pain levels and patient's use of opioids and other analgesic drugs to moderate pain following third molar surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 23, 2023

Status Verified

December 1, 2022

Enrollment Period

4.8 years

First QC Date

February 28, 2018

Last Update Submit

February 22, 2023

Conditions

Pain, Post-operative

Outcome Measures

Primary Outcomes (1)

  • The impact of the surgery on the patient's post-surgery pain.

    Likert scales for average pain and worst pain are assessed with 7-point scales with verbal anchors of "no pain" and "worst pain imagined". Recovery for pain on the Likert scales is defined as the number of PSD until the patient reports a score of 1 or 2 on the 7-point scale.

    14 days

Interventions

third molar surgeryPROCEDURE

The patient is asked to complete the diary each post-surgery day for 14 days. Recovery is organized into three QOL domains: lifestyle, oral function, and pain.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients scheduled for surgery at UNC oral and maxillofacial surgery clinic

You may qualify if:

  • ASA I,II At least two lower 3rd molars scheduled for removal

You may not qualify if:

  • Patient being treated for opioid addiction/abuse including having Rx for suboxone, methadone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina School of Dentistry

Chapel Hill, North Carolina, 27599-7450, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Glenn Reside, DMD

    UNC oral and maxillofacial surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 7, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 23, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)