NCT02929602

Brief Summary

Opioid analgesics prescribed by dentists may contribute to the larger national issue of the use and abuse of the drug. On occasion dental pain may be sufficiently severe to support the use of opioids. This study used both dentist and patient input to evaluate the use of opioid and over-the-counter analgesics following one of seven coded common dental procedures. The study includes a five day patient follow up assessment of the effectiveness of the analgesic. Baseline questionnaires were completed by eligible participants, and they responded to the day 5 follow up questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,773

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

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

Study Start

First participant enrolled

June 1, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

4.4 years

First QC Date

February 5, 2016

Last Update Submit

October 7, 2016

Conditions

Keywords

prescribingeffectivenessdentalopioidanalgesic

Outcome Measures

Primary Outcomes (1)

  • Dentist questionnaire

    dentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)

    baseline

Secondary Outcomes (2)

  • Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale

    5 days after the dental procedure

  • Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).

    5 days after the dental procedure

Other Outcomes (1)

  • Patient questionnaire - side effects of analgesics post dental procedure

    5 days post dental procedure

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Practice-based study. Patients recruited from the practice sites of PEARL Network dentists.

You may qualify if:

  • Presence of erupted second molar teeth.
  • Scheduled for treatment in one procedure of the following six procedure classes:
  • extraction, endodontic therapy, pulp capping, crown preparation, periodontal surgery, abscess treatment
  • Expected by the P-I to experience postoperative pain sufficient to require an analgesic
  • Permanent dentition (erupted 2nd molar teeth)
  • Capacity to judge pain level
  • Ability and willingness to give verbal consent

You may not qualify if:

  • Under treatment for medical disorders, including dementia, Parkinson's disease, depression, severe anxiety, or any other medical condition, that, in the opinion of the P-I, would affect the subject's judgment of postoperative pain
  • Current participation in another dental or medical research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PEARL Network Sites

New York, New York, 10010, United States

Location

Related Publications (1)

  • Wong YJ, Keenan J, Hudson K, Bryan H, Naftolin F, Thompson VP, Craig RG, Vena D, Collie D, Wu H, Matthews AG, Grill AC, Curro FA. Opioid, NSAID, and OTC Analgesic Medications for Dental Procedures: PEARL Network Findings. Compend Contin Educ Dent. 2016 Nov/Dec;37(10):710-718.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frederick A Curro, DMD, PhD

    Pearl Network

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 5, 2016

First Posted

October 11, 2016

Study Start

June 1, 2007

Primary Completion

November 1, 2011

Study Completion

June 1, 2014

Last Updated

October 11, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Will send to the NIDCR.

Locations