Periodontal DiseasesNCT03064178
Use of Pain Medication Following Periodontal Procedures
An observational study of Periodontal Diseases and Pain, run by Brock University.
Trial summary
This study had the following aims: i. to determine the relationship between anticipated pain and actual pain experienced following periodontal surgery; and ii. determine the factors that predict the amount of pain and the amount of pain medication use following periodontal surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Periodontal Diseases, Pain
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2014to 15 Aug 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were recruited from a periodontal clinic in Southern Ontario, Canada. Patients were in need of dental implant surgery or soft tissue graft surgery.
Who may be able to join
- require dental implant surgery or soft tissue graft surgery
Who cannot join
- regularly took pain medication for pre-existing health conditions
- previous implant or soft tissue graft surgery
About this study
Official title: Anticipated Versus Actual Pain Associated With Periodontal Surgery and Use of Pain Medication
This study had the following aims: i. to determine the relationship between anticipated pain and actual pain experienced following periodontal surgery; and ii. determine the factors that predict the amount of pain and the amount of pain medication use following periodontal surgery.
It was hypothesized that experienced pain will be significantly less than anticipated pain. It was also hypothesized that the following factors will affect pain experienced: sex, type of surgery, nervousness, anticipated pain, sedation, age, smoking status, supplement use and pain pill usage. It was hypothesized that the following factors will affect pain pill usage: sex, type of surgery, nervousness, anticipated pain, sedation, age, smoking status, supplement use, and actual pain.
Read the detailed description
Patients may delay or avoid periodontal procedures because of fear of dental pain they will experience. By understanding factors that influence pain experienced, practitioners can provide potentially provide accommodations for their patients. This study investigated if anticipated pain is similar to actual pain experienced and if there are certain factors that influence the amount of pain experienced and/or pain pill usage.
Patients kept a 7 day diary in which they recorded anticipated pain (prior to periodontal surgery) and actual pain experienced for 7 days following the surgical procedure. Patients recorded their pain (anticipated and actual) using a visual analog scale (VAS). Patients also recorded daily pain medication and nutritional supplement use in the 7 day diary.
Other information recorded included factors that could influence pain experienced and pain pill use. For pain experienced, the influence of the following factors were assessed: sex, age, type of surgery, nervousness, sedation use, smoking status, anticipated pain, nutritional supplement use and pain pill use. For pain pill use, the influence of the following factors were assessed: sex, age, type of surgery, nervousness, sedation use, smoking status, anticipated pain, nutritional supplement use and pain experienced. These factors were analyzed using regression analyses.
- Conditions
- Periodontal Diseases, Pain
- Keywords
- periodontal therapy, anticipated pain, experienced pain, pain medication use
- Medical subject headings
- Periodontal Diseases, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between anticipated pain and actual pain experienced
Visual analog scale used (mm)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start10 May 2014
- Primary completion7 Mar 2016
- Study completion15 Aug 2016
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 Periodontal DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy E. Ward, Ph.D., Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064178
- Sponsor's protocol ID
- 13-172
- Status last verified
- Feb 2017
- First submitted
- 19 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beaudette JR, Fritz PC, Sullivan PJ, Piccini A, Ward WE. Investigation of factors that influence pain experienced and the use of pain medication following periodontal surgery. J Clin Periodontol. 2018 May;45(5):578-585. doi: 10.1111/jcpe.12885. Epub 2018 Apr 16.
PubMed 29500837
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipated Versus Actual Pain Associated With Periodontal Surgery and Use of Pain Medication
- ClinicalTrials.gov ID
- NCT03064178
- Acronym / sponsor ID
- 13-172
- Conditions
- Periodontal Diseases, Pain
- Keywords
- periodontal therapy, anticipated pain, experienced pain, pain medication use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- 10 May 2014 (actual)
- Primary completion
- 7 Mar 2016 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 24 Feb 2017 (actual)
- 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.
This study had the following aims: i. to determine the relationship between anticipated pain and actual pain experienced following periodontal surgery; and ii. determine the factors that predict the amount of pain and the amount of pain medication use following periodontal surgery.
It was hypothesized that experienced pain will be significantly less than anticipated pain. It was also hypothesized that the following factors will affect pain experienced: sex, type of surgery, nervousness, anticipated pain, sedation, age, smoking status, supplement use and pain pill usage. It was hypothesized that the following factors will affect pain pill usage: sex, type of surgery, nervousness, anticipated pain, sedation, age, smoking status, supplement use, and actual pain.
Detailed description
Patients may delay or avoid periodontal procedures because of fear of dental pain they will experience. By understanding factors that influence pain experienced, practitioners can provide potentially provide accommodations for their patients. This study investigated if anticipated pain is similar to actual pain experienced and if there are certain factors that influence the amount of pain experienced and/or pain pill usage.
Patients kept a 7 day diary in which they recorded anticipated pain (prior to periodontal surgery) and actual pain experienced for 7 days following the surgical procedure. Patients recorded their pain (anticipated and actual) using a visual analog scale (VAS). Patients also recorded daily pain medication and nutritional supplement use in the 7 day diary.
Other information recorded included factors that could influence pain experienced and pain pill use. For pain experienced, the influence of the following factors were assessed: sex, age, type of surgery, nervousness, sedation use, smoking status, anticipated pain, nutritional supplement use and pain pill use. For pain pill use, the influence of the following factors were assessed: sex, age, type of surgery, nervousness, sedation use, smoking status, anticipated pain, nutritional supplement use and pain experienced. These factors were analyzed using regression analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from a periodontal clinic in Southern Ontario, Canada. Patients were in need of dental implant surgery or soft tissue graft surgery.
Key inclusion criteria (1 listed)
- require dental implant surgery or soft tissue graft surgery
Key exclusion criteria (2 listed)
- regularly took pain medication for pre-existing health conditions
- previous implant or soft tissue graft surgery
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
Relationship between anticipated pain and actual pain experienced
Time frame: 7 days
Visual analog scale used (mm)
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 24 Feb 2017.
- Derived from this study: PubMed 29500837Beaudette JR, Fritz PC, Sullivan PJ, Piccini A, Ward WE. Investigation of factors that influence pain experienced and the use of pain medication following periodontal surgery. J Clin Periodontol. 2018 May;45(5):578-585. doi: 10.1111/jcpe.12885. Epub 2018 Apr 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Pain, run by Brock University.
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 1 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Relationship between anticipated pain and actual pain experienced (time frame: 7 days). 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 NCT03064178, 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 24 Feb 2017.