Analgesic Use and Effectiveness for Dental Procedures | NCT02929602

Studies
Analgesic Use and Effectiveness for Dental Procedures

NCT02929602

Sponsor

Pearl Network

Status

Completed

Last Update Posted

Oct 11, 2016Estimated

Enrollment

2,773Actual

Phase

Not provided

Conditions

Pain

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
U01DE016755	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Nov 2011Actual

Completion Date

Jun 2014Actual

First Submitted Date

Feb 5, 2016

First Submission Date that Met QC Criteria

Oct 7, 2016

First Posted Date

Oct 11, 2016Estimated

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

Oct 7, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Name	Class
National Institute of Dental and Craniofacial Research (NIDCR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

Specific Aims The overall objective of the proposed study is to determine (1) the pattern of analgesic prescriptions (Rx and OTC) and recommendations (OTC) in dental practices; and (2) the effectiveness of and side effects associated with these medications as measured by patientreported outcomes (PROs).

Specific Aim 1: To document (a) dentists' postprocedural prescriptions and recommendations for analgesic medication: and (b) the effectiveness of these medications and side effects associated with their use as measured by PROs.

Specific Aim 2: To analyze by procedure class and anticipated pain severity the PROs of Rx and OTC analgesic medications.

Specific Aim 3: Determine the incidence of analgesic side effects of Rx and OTC analgesic medications.

The outcomes of Specific Aims 1-3 will be:

The distribution of dentists' Rx/OTC prescriptions/recommendations by dentists for anticipated pain severity.
The effectiveness of different types of Rx and OTC analgesics (e.g., Rx NSAIDs vs. OTC NSAIDs, Rx NSAIDs vs. Rx narcotics) by procedure class and anticipated pain severity.
The incidence of analgesic side effects for Rx and OTC analgesics. Analysis of the results and methods of the proposed research will furthermore serve as guidance in designing a randomized PBRN clinical trial comparing the efficacy of and complications associated with two or more analgesics.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,773Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dentist questionnaire	dentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)	baseline

Secondary Outcomes

Measure	Description	Time Frame
Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale	anticipated pain severity using the VAS-5 pain scale (1-5 scale)	5 days after the dental procedure
Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).

Other Outcomes

Measure	Description	Time Frame
Patient questionnaire - side effects of analgesics post dental procedure	(Descriptive methods were used) to determine side effects: Yes/no, describe for Rx and OTC analgesic medications.	5 days post dental procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Frederick A Curro, DMD, PhD	Pearl Network	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
PEARL Network Sites		New York	New York	10010	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27875056	Derived	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.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms