PainNCT02929602
Analgesic Use and Effectiveness for Dental Procedures
An observational study of Pain, run by Pearl Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 2,773 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Practice-based study. Patients recruited from the practice sites of PEARL Network dentists.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRL0706: Analgesic Use and Effectiveness
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.
Read the 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.
- Conditions
- Pain
- Keywords
- prescribing, effectiveness, dental, opioid, analgesic
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentist questionnaire
dentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)
Measured: baseline
Secondary outcomes (2)
Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale
anticipated pain severity using the VAS-5 pain scale (1-5 scale)
Measured: 5 days after the dental procedure
Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).
Measured: 5 days after the dental procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJun 2007
- Primary completionNov 2011
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Frederick A Curro, DMD, PhD, Principal investigator, Pearl Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929602
- Sponsor's protocol ID
- PRL0706
- Other IDs
- U01DE016755
- Status last verified
- Oct 2016
- First submitted
- 5 Feb 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Will send to the NIDCR.
Publications
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.
PubMed 27875056
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRL0706: Analgesic Use and Effectiveness
- ClinicalTrials.gov ID
- NCT02929602
- Acronym / sponsor ID
- PRL0706
- Conditions
- Pain
- Keywords
- prescribing, effectiveness, dental, opioid, analgesic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,773 participants (actual)
- Lead sponsor
- Pearl NetworkResearch network
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jun 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Practice-based study. Patients recruited from the practice sites of PEARL Network dentists.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dentist questionnaire
Time frame: baseline
dentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)
2 secondary outcomes
Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale
Time frame: 5 days after the dental procedure
Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).
Time frame: 5 days after the dental procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Derived from this study: PubMed 27875056Wong 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.
- Individual participant dataSharing planned: Yes. Will send to the NIDCR.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick A Curro, DMD, PhD principal investigator
Pearl Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Pearl Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentist questionnaire (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.