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Completed

NCT Number: NCT02929602

Analgesic Use and Effectiveness for Dental Procedures

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

PEARL Network Sites

New York, 10010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Dentist questionnaire

    Time frame: baseline

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

Secondary outcomes

  1. Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale

    Time frame: 5 days after the dental procedure

    anticipated pain severity using the VAS-5 pain scale (1-5 scale)

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

    Time frame: 5 days after the dental procedure

Other outcomes

  1. Patient questionnaire - side effects of analgesics post dental procedure

    Time frame: 5 days post dental procedure

    (Descriptive methods were used) to determine side effects: Yes/no, describe for Rx and OTC analgesic medications.

Sponsors and collaborators

Lead sponsor

Pearl Network

Network

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

PRL0706: Analgesic Use and Effectiveness

Important dates

Study start
2007
Primary completion
2011
Study completion
2014
First posted
Oct 11, 2016
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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