Dental CrowdingPhase 4NCT00385216
Nicotine as an Adjuvant Analgesic for Third Molar Surgery
A Phase 4 study testing Nicotine in people with Dental Crowding, run by Columbia University at 1 site in United States.
Trial summary
Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dental Crowding
- What is being tested?
- Nicotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- over 18
- 4 molars to be removed
Who cannot join
- pregnant
- lactating
- chronic pain
- narcotic use
- asthma
- ex-smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nicotine on Pain After Third Molar Extraction.
Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine or placebo as a nasal spray before surgery to determine whether nicotine affects pain or inflammation.
Read the detailed description
This is a randomized double blind cross-over study. In each of two sittings, the third molars on one side of the mouth are removed. In one sitting the subject will receive a nicotine nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared within patients.
- Conditions
- Dental Crowding
- Being tested
- Nicotine, Placebo
- Keywords
- Third Molar, Pain
- Medical subject headings
- Crowding, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Also called Nasal spray, nicotine
Nicotine nasal spray 3mg x 1 before surgery
PlaceboOther
Also called Nasal spray, placebo
Placebo nasal spray 0mg x 1 before surgery
| Study group | Role | What they receive |
|---|---|---|
| Nicotine nasal spray | Active comparator | In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application. Receives: Drug: Nicotine |
| Placebo spray | Placebo comparator | In one sitting the subject will receive a placebo nasal spray (0 mg), one application. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reported by Patient
Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.
Measured: Up to 1 day
Secondary outcomes (5)
Heart Rate
Heart rate reported in beats per minute (BPM)
Measured: 5 days
Systolic Blood Pressure
Systolic blood pressure reported in Millimeters of Mercury (mmHg)
Measured: 5 days
Diastolic Blood Pressure
Diastolic blood pressure reported in Millimeters of Mercury (mmHg)
Measured: 5 days
Difference in Amount of Nausea Reported
For an hour postoperatively, subjects reported information on pain and nausea, and hemodynamic variables were recorded at 15-minute intervals. Telephone follow-up was recorded for 5 days postoperatively, where patients reported information on pain, nausea, and use of hydrocodone/acetaminophen as rescue analgesia.
Measured: 5 days
Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery
All patients were prescribed Hydrocodone 5 mg / Acetaminophen 325 mg and were instructed to take 1 to 2 tablets for oral pain at a maximum of every 4 to 6 hours post-surgery.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startJul 2004
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CrowdingStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Flood, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385216
- Sponsor's protocol ID
- AAAA6273
- Status last verified
- Sep 2024
- First submitted
- 5 Oct 2006
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nicotine on Pain After Third Molar Extraction.
- ClinicalTrials.gov ID
- NCT00385216
- Acronym / sponsor ID
- AAAA6273
- Conditions
- Dental Crowding
- Keywords
- Third Molar, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Oct 2006 (estimated)
- Results
- Posted 27 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine or placebo as a nasal spray before surgery to determine whether nicotine affects pain or inflammation.
Detailed description
This is a randomized double blind cross-over study. In each of two sittings, the third molars on one side of the mouth are removed. In one sitting the subject will receive a nicotine nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared within patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine nasal spray | Active comparator | Drug: NicotineIn one sitting the subject will receive a nicotine nasal spray, 3 mg, one application. |
| Placebo spray | Placebo comparator | Other: PlaceboIn one sitting the subject will receive a placebo nasal spray (0 mg), one application. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- over 18
- 4 molars to be removed
Key exclusion criteria (6 listed)
- pregnant
- lactating
- chronic pain
- narcotic use
- asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotineAlso: Nasal spray, nicotineNicotine nasal spray 3mg x 1 before surgery | Drug | Nicotine nasal spray |
| PlaceboAlso: Nasal spray, placeboPlacebo nasal spray 0mg x 1 before surgery | Other | Placebo spray |
Primary outcome
Pain Reported by Patient
Time frame: Up to 1 day
Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.
5 secondary outcomes
Heart Rate
Time frame: 5 days
Systolic Blood Pressure
Time frame: 5 days
Diastolic Blood Pressure
Time frame: 5 days
Difference in Amount of Nausea Reported
Time frame: 5 days
Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
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Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
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Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
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.
Pamela Flood, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine in people with Dental Crowding, run by Columbia University 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 2 inclusion and 6 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 19 Sep 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Reported by Patient (time frame: Up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.