Postoperative PainNCT00805298
Assessment of the Operative Course in Connection With Removal of Lower Third Molars
A study testing methylprednisolone, xyloplyin adrenalin and marcain adrenalin in people with Postoperative Pain and Inflammation, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to compare postoperative complications after removal of lower third molars using two different types of anaesthetics and two different treatments against swelling and inflammation (methylprednisolone and placebo). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Inflammation
- What is being tested?
- methylprednisolone, xyloplyin adrenalin and marcain adrenalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Nov 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- two impacted or semi-impacted lower third molars with indication for removal
- signed informed consent
Who cannot join
- allergy to study drugs or ingredients
- need for sedation
- pregnancy
- systemic disease besides asthma/hay fever
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling
The aim of this study is to compare postoperative complications after removal of lower third molars using two different types of anaesthetics and two different treatments against swelling and inflammation (methylprednisolone and placebo). The hypothesis is that a combination of a long-duration anaesthetic combined methylprednisolone will result in significantly less postoperative pain and inflammation.
Patients will have both lower third molars removed on two separate occasions. Each patient is randomly assigned to receive one type of local anaesthetic the first time and the other type the second time. Furthermore patients are randomised to receive either methylprednisolone or placebo the first time and the opposite treatment the second time.
During the week after surgery patients fill out a questionnaire with questions about level of pain and swelling at different times as well as the patients' perception of other postoperative complications. The patient is examined by a dentist on the 2nd and 7th day after surgery, where postoperative complications are recorded and thermographic images of the patient's face are taken to assess the degree of inflammation.
Read the detailed description
Background: After removal of lower third molars complications can occur, including pain, swelling, infection and sensory disturbances. As pain intensity has been shown to be worst during the first 4-8 hours post surgery, it might be relevant to use a local anaesthetic with long duration, e.g. bupivacaine, instead of the traditionally used lidocaine. Several studies have focussed on the effect of non-steroid anti-inflammatory drugs (such as glucocorticoids, e.g. methylprednisolone) to reduce postoperative swelling. However, no studies comparing the effect of bupivacaine combined with methylprednisolone and lidocaine combined with methylprednisolone have been conducted.
Aim: To compare postoperative complications after removal of lower third molars using 1) lidocaine, 2) lidocaine combined with methylprednisolone, 3) bupivacaine and 4) bupivacaine combined with methylprednisolone.
Methods: The study compares type end extension of postoperative complications after removal of lower third molars using four different combinations of local anaesthetics and anti-inflammatory treatment. The study is conducted as a double blinded, split mouth crossover trial, where each patient has both lower third molars removed at two different occasions.
Patients are randomised to receive one type of local anaesthetic the first time and the other type the second time. Furthermore patients are randomised to receive either methylprednisolone or placebo the first time and the opposite treatment the second time.
An objective assessment of postoperative swelling and inflammation is made by means of thermographic imaging of the operated side compared to the opposite side after the operation and at 2 and 7 days post surgery.
Each patient fills out a questionnaire, where the patients' perception of pain, swelling and other complications is registered. Furthermore, complications are recorded objectively by a dentist at the 2- and 7-day post-surgery visits
- Conditions
- Postoperative Pain, Inflammation
- Being tested
- methylprednisolone, placebo, xyloplyin adrenalin, marcain adrenalin
- Keywords
- third molar, postoperative pain, thermography, postoperative inflammation, methylprednisolone, local anaesthetic, postoperative pain after removal of lower third molars, inflammation after removal of lower third molars
- Medical subject headings
- Pain, Postoperative, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called medrol
32 mg before surgery, 16 mg twice daily the day after surgery
placeboDrug
two tablets before surgery, one tablet twice daily on the day after surgery
xyloplyin adrenalinDrug
lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.
marcain adrenalinDrug
bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone | Active comparator | Not described Receives: Drug: methylprednisolone |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| lidocaine | Active comparator | Not described Receives: Drug: xyloplyin adrenalin |
| bupivacaine | Active comparator | Not described Receives: Drug: marcain adrenalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: within the first week after surgery
postoperative inflammation
Measured: within the first week after surgery
Secondary outcomes (5)
use of analgesics
Measured: within one week after surgery
absence from work
Measured: within one week after surgery
trismus
Measured: within one week after surgery
alveolitis (dry socket)
Measured: within one week after surgery
sensory disturbance
Measured: within one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Tandlaegeforeningen, Calcin fonden
- Responsible party
- Sponsor
- Investigators
- Jennifer H Christensen, DDS, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805298
- Sponsor's protocol ID
- 2008-000866-22
- Other IDs
- 01.01.08Jen, 2008
- Status last verified
- Oct 2012
- First submitted
- 8 Dec 2008
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beirne OR, Hollander B. The effect of methylprednisolone on pain, trismus, and swelling after removal of third molars. Oral Surg Oral Med Oral Pathol. 1986 Feb;61(2):134-8. doi: 10.1016/0030-4220(86)90173-8.
PubMed 3457335Bouloux GF, Punnia-Moorthy A. Bupivacaine versus lidocaine for third molar surgery: a double-blind, randomized, crossover study. J Oral Maxillofac Surg. 1999 May;57(5):510-4; discussion 515. doi: 10.1016/s0278-2391(99)90063-0.
PubMed 10319823Bruce RA, Frederickson GC, Small GS. Age of patients and morbidity associated with mandibular third molar surgery. J Am Dent Assoc. 1980 Aug;101(2):240-5. doi: 10.14219/jada.archive.1980.0183.
PubMed 6931159Bystedt H, Nordenram A. Effect of methylprednisolone on complications after removal of impacted mandibular third molars. Swed Dent J. 1985;9(2):65-9.
PubMed 3859943Campbell WI, Kendrick RW, Ramsay-Baggs P, McCaughey W. The effect of pre-operative administration of bupivacaine compared with its postoperative use. Anaesthesia. 1997 Dec;52(12):1212-6.
PubMed 9485979Chiapasco M, De Cicco L, Marrone G. Side effects and complications associated with third molar surgery. Oral Surg Oral Med Oral Pathol. 1993 Oct;76(4):412-20. doi: 10.1016/0030-4220(93)90005-o.
PubMed 8233418de Boer MP, Raghoebar GM, Stegenga B, Schoen PJ, Boering G. Complications after mandibular third molar extraction. Quintessence Int. 1995 Nov;26(11):779-84.
PubMed 8628837Esen E, Tasar F, Akhan O. Determination of the anti-inflammatory effects of methylprednisolone on the sequelae of third molar surgery. J Oral Maxillofac Surg. 1999 Oct;57(10):1201-6; discussion 1206-8. doi: 10.1016/s0278-2391(99)90486-x.
PubMed 10513866Holland CS. The influence of methylprednisolone on post-operative swelling following oral surgery. Br J Oral Maxillofac Surg. 1987 Aug;25(4):293-9. doi: 10.1016/0266-4356(87)90068-4.
PubMed 3304412Leone M, Richard O, Antonini F, Rousseau S, Chabaane W, Guyot L, Martin C. Comparison of methylprednisolone and ketoprofen after multiple third molar extraction: a randomized controlled study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jan;103(1):e7-9. doi: 10.1016/j.tripleo.2006.07.005. Epub 2006 Oct 6.
PubMed 17178485Markovic AB, Todorovic L. Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenac. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):e4-8. doi: 10.1016/j.tripleo.2006.02.024. Epub 2006 Aug 10.
PubMed 17052624Mellor DJ, Mellor AH, McAteer EM. Local anaesthetic infiltration for surgical exodontia of third molar teeth: a double-blind study comparing bupivacaine infiltration with i.v. ketorolac. Br J Anaesth. 1998 Oct;81(4):511-4. doi: 10.1093/bja/81.4.511.
PubMed 9924222Mettes TG, Nienhuijs ME, van der Sanden WJ, Verdonschot EH, Plasschaert AJ. Interventions for treating asymptomatic impacted wisdom teeth in adolescents and adults. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003879. doi: 10.1002/14651858.CD003879.pub2.
PubMed 15846686Mico-Llorens JM, Satorres-Nieto M, Gargallo-Albiol J, Arnabat-Dominguez J, Berini-Aytes L, Gay-Escoda C. Efficacy of methylprednisolone in controlling complications after impacted lower third molar surgical extraction. Eur J Clin Pharmacol. 2006 Sep;62(9):693-8. doi: 10.1007/s00228-006-0164-5. Epub 2006 Aug 11.
PubMed 16902792Moore PA. Bupivacaine: a long-lasting local anesthetic for dentistry. Oral Surg Oral Med Oral Pathol. 1984 Oct;58(4):369-74. doi: 10.1016/0030-4220(84)90325-6.
PubMed 6387571
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling
- ClinicalTrials.gov ID
- NCT00805298
- Acronym / sponsor ID
- 2008-000866-22
- Conditions
- Postoperative Pain, Inflammation
- Keywords
- third molar, postoperative pain, thermography, postoperative inflammation, methylprednisolone, local anaesthetic, postoperative pain after removal of lower third molars, inflammation after removal of lower third molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Tandlaegeforeningen, Calcin fonden
- Study start
- Aug 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Dec 2008 (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.
The aim of this study is to compare postoperative complications after removal of lower third molars using two different types of anaesthetics and two different treatments against swelling and inflammation (methylprednisolone and placebo). The hypothesis is that a combination of a long-duration anaesthetic combined methylprednisolone will result in significantly less postoperative pain and inflammation.
Patients will have both lower third molars removed on two separate occasions. Each patient is randomly assigned to receive one type of local anaesthetic the first time and the other type the second time. Furthermore patients are randomised to receive either methylprednisolone or placebo the first time and the opposite treatment the second time.
During the week after surgery patients fill out a questionnaire with questions about level of pain and swelling at different times as well as the patients' perception of other postoperative complications. The patient is examined by a dentist on the 2nd and 7th day after surgery, where postoperative complications are recorded and thermographic images of the patient's face are taken to assess the degree of inflammation.
Detailed description
Background: After removal of lower third molars complications can occur, including pain, swelling, infection and sensory disturbances. As pain intensity has been shown to be worst during the first 4-8 hours post surgery, it might be relevant to use a local anaesthetic with long duration, e.g. bupivacaine, instead of the traditionally used lidocaine. Several studies have focussed on the effect of non-steroid anti-inflammatory drugs (such as glucocorticoids, e.g. methylprednisolone) to reduce postoperative swelling. However, no studies comparing the effect of bupivacaine combined with methylprednisolone and lidocaine combined with methylprednisolone have been conducted.
Aim: To compare postoperative complications after removal of lower third molars using 1) lidocaine, 2) lidocaine combined with methylprednisolone, 3) bupivacaine and 4) bupivacaine combined with methylprednisolone.
Methods: The study compares type end extension of postoperative complications after removal of lower third molars using four different combinations of local anaesthetics and anti-inflammatory treatment. The study is conducted as a double blinded, split mouth crossover trial, where each patient has both lower third molars removed at two different occasions.
Patients are randomised to receive one type of local anaesthetic the first time and the other type the second time. Furthermore patients are randomised to receive either methylprednisolone or placebo the first time and the opposite treatment the second time.
An objective assessment of postoperative swelling and inflammation is made by means of thermographic imaging of the operated side compared to the opposite side after the operation and at 2 and 7 days post surgery.
Each patient fills out a questionnaire, where the patients' perception of pain, swelling and other complications is registered. Furthermore, complications are recorded objectively by a dentist at the 2- and 7-day post-surgery visits
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone | Active comparator | Drug: methylprednisolone |
| placebo | Placebo comparator | Drug: placebo |
| lidocaine | Active comparator | Drug: xyloplyin adrenalin |
| bupivacaine | Active comparator | Drug: marcain adrenalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- two impacted or semi-impacted lower third molars with indication for removal
- signed informed consent
Key exclusion criteria (4 listed)
- allergy to study drugs or ingredients
- need for sedation
- pregnancy
- systemic disease besides asthma/hay fever
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 |
|---|---|---|
| methylprednisoloneAlso: medrol32 mg before surgery, 16 mg twice daily the day after surgery | Drug | methylprednisolone |
| placebotwo tablets before surgery, one tablet twice daily on the day after surgery | Drug | placebo |
| xyloplyin adrenalinlidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml. | Drug | lidocaine |
| marcain adrenalinbupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml | Drug | bupivacaine |
Primary outcome
postoperative pain
Time frame: within the first week after surgery
postoperative inflammation
Time frame: within the first week after surgery
5 secondary outcomes
use of analgesics
Time frame: within one week after surgery
absence from work
Time frame: within one week after surgery
trismus
Time frame: within one week after surgery
alveolitis (dry socket)
Time frame: within one week after surgery
sensory disturbance
Time frame: within one week after surgery
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 Oct 2012.
- Background: PubMed 3457335Beirne OR, Hollander B. The effect of methylprednisolone on pain, trismus, and swelling after removal of third molars. Oral Surg Oral Med Oral Pathol. 1986 Feb;61(2):134-8. doi: 10.1016/0030-4220(86)90173-8.
- Background: PubMed 10319823Bouloux GF, Punnia-Moorthy A. Bupivacaine versus lidocaine for third molar surgery: a double-blind, randomized, crossover study. J Oral Maxillofac Surg. 1999 May;57(5):510-4; discussion 515. doi: 10.1016/s0278-2391(99)90063-0.
- Background: PubMed 6931159Bruce RA, Frederickson GC, Small GS. Age of patients and morbidity associated with mandibular third molar surgery. J Am Dent Assoc. 1980 Aug;101(2):240-5. doi: 10.14219/jada.archive.1980.0183.
- Background: PubMed 3859943Bystedt H, Nordenram A. Effect of methylprednisolone on complications after removal of impacted mandibular third molars. Swed Dent J. 1985;9(2):65-9.
- Background: PubMed 9485979Campbell WI, Kendrick RW, Ramsay-Baggs P, McCaughey W. The effect of pre-operative administration of bupivacaine compared with its postoperative use. Anaesthesia. 1997 Dec;52(12):1212-6.
- Background: PubMed 8233418Chiapasco M, De Cicco L, Marrone G. Side effects and complications associated with third molar surgery. Oral Surg Oral Med Oral Pathol. 1993 Oct;76(4):412-20. doi: 10.1016/0030-4220(93)90005-o.
- Background: PubMed 8628837de Boer MP, Raghoebar GM, Stegenga B, Schoen PJ, Boering G. Complications after mandibular third molar extraction. Quintessence Int. 1995 Nov;26(11):779-84.
- Background: PubMed 10513866Esen E, Tasar F, Akhan O. Determination of the anti-inflammatory effects of methylprednisolone on the sequelae of third molar surgery. J Oral Maxillofac Surg. 1999 Oct;57(10):1201-6; discussion 1206-8. doi: 10.1016/s0278-2391(99)90486-x.
- Background: PubMed 3304412Holland CS. The influence of methylprednisolone on post-operative swelling following oral surgery. Br J Oral Maxillofac Surg. 1987 Aug;25(4):293-9. doi: 10.1016/0266-4356(87)90068-4.
- Background: PubMed 17178485Leone M, Richard O, Antonini F, Rousseau S, Chabaane W, Guyot L, Martin C. Comparison of methylprednisolone and ketoprofen after multiple third molar extraction: a randomized controlled study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jan;103(1):e7-9. doi: 10.1016/j.tripleo.2006.07.005. Epub 2006 Oct 6.
- Background: PubMed 17052624Markovic AB, Todorovic L. Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenac. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):e4-8. doi: 10.1016/j.tripleo.2006.02.024. Epub 2006 Aug 10.
- Background: PubMed 9924222Mellor DJ, Mellor AH, McAteer EM. Local anaesthetic infiltration for surgical exodontia of third molar teeth: a double-blind study comparing bupivacaine infiltration with i.v. ketorolac. Br J Anaesth. 1998 Oct;81(4):511-4. doi: 10.1093/bja/81.4.511.
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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.
Jennifer H Christensen, DDS principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylprednisolone, xyloplyin adrenalin and marcain adrenalin in people with Postoperative Pain and Inflammation, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 4 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 Oct 2012. 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 Denmark. 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.
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?
postoperative pain (time frame: within the first week after surgery). The study lists 2 primary outcomes in all. 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 NCT00805298, which also lists 24 linked publications.
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 Oct 2012.