TrismusNCT03170713
Impact of Preemptive Intravenous Ibuprofen on Postoperative Edema and Trismus in the Third Molar Teeth
A study testing arveles and intrafen in people with Trismus and Edema, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
this study was planned to investigate the antiinflammatory activity of preemptive intravenous ibuprofen on inflammatory complications such as edema and trismus after third molar tooth surgery Read more about this study
- Who is it for?
- Ages 20 to 35 years
- What is being tested?
- arveles and intrafen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2017to 15 Nov 2017
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elective 3. Molar tooth extraction
- Patients between the ages of 20-35
- Patients who are symptomatic
- 3. Molar tooth angular or horizontal settled patients
Who cannot join
- Patients who refuse to participate in the study
- Patients under 20 years old, over 35 years old
- Patients who are allergic to known non-steroidal anti-inflammatory drugs
- Pregnant patients
- Patients with severe hepatic insufficiency
- Patients with severe renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
this study was planned to investigate the antiinflammatory activity of preemptive intravenous ibuprofen on inflammatory complications such as edema and trismus after third molar tooth surgery
- Being tested
- arveles, intrafen, placebos
- Keywords
- Preemptive intravenous ibuprofen, trismus, edema, Third molar tooth extraction, Antiinflammatory effect
- Medical subject headings
- Trismus, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arvelesDrug
Also called dexketoprofen
800 mg ibuprofen and 50 mg dexketoprofen in 150 cc normal saline before operation will be given in 30 minutes. The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.
intrafenDrug
Also called ibuprofen i.v.
800 mg ibuprofen in 150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.
placebosOther
150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.
| Study group | Role | What they receive |
|---|---|---|
| arveles | Active comparator | 800 mg ibuprofen and 50 mg arveles in 150 cc normal saline before operation will be given in 30 minutes. Receives: Drug: arveles; Drug: intrafen; Other: placebos |
| intrafen | Active comparator | intrafen 800 mg in 150 cc normal saline before operation will be given in 30 minutes. Receives: Drug: arveles; Drug: intrafen; Other: placebos |
| placebos | Placebo comparator | Pre-operative 150 cc normal saline will be delivered in 30 minutes Receives: Drug: arveles; Drug: intrafen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema size measured by tape measure method
the effect of preemptive intravenous ibuprofen on postoperative edema size
Measured: 6 month
Secondary outcomes (1)
Maximum mouth opening measured with vernier caliper
the effect of preemptive intravenous ibuprofen on postoperative trismus rate
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start15 May 2017
- Primary completion30 Oct 2017 (estimated)
- Study completion15 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for TrismusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
- Investigators
- ilke kupeli, Principal investigator, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170713
- Sponsor's protocol ID
- ERZINCAN UNIVERSITY 10
- Status last verified
- May 2017
- First submitted
- 20 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jerjes W, El-Maaytah M, Swinson B, Banu B, Upile T, D'Sa S, Al-Khawalde M, Chaib B, Hopper C. Experience versus complication rate in third molar surgery. Head Face Med. 2006 May 25;2:14. doi: 10.1186/1746-160X-2-14.
PubMed 16725024Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):117-28, vii. doi: 10.1016/j.coms.2006.11.013.
PubMed 18088870Chukwuneke F, Onyejiaka N. Management of postoperative morbidity after third molar surgery: a review of the literature. Niger J Med. 2007 Apr-Jun;16(2):107-12. doi: 10.4314/njm.v16i2.37291.
PubMed 17694761Colorado-Bonnin M, Valmaseda-Castellon E, Berini-Aytes L, Gay-Escoda C. Quality of life following lower third molar removal. Int J Oral Maxillofac Surg. 2006 Apr;35(4):343-7. doi: 10.1016/j.ijom.2005.08.008. Epub 2005 Nov 8.
PubMed 16280233Vegas-Bustamante E, Mico-Llorens J, Gargallo-Albiol J, Satorres-Nieto M, Berini-Aytes L, Gay-Escoda C. Efficacy of methylprednisolone injected into the masseter muscle following the surgical extraction of impacted lower third molars. Int J Oral Maxillofac Surg. 2008 Mar;37(3):260-3. doi: 10.1016/j.ijom.2007.07.018. Epub 2008 Mar 4.
PubMed 18296027Chukwuneke FN, Oji C, Saheeb DB. A comparative study of the effect of using a rubber drain on postoperative discomfort following lower third molar surgery. Int J Oral Maxillofac Surg. 2008 Apr;37(4):341-4. doi: 10.1016/j.ijom.2007.11.016. Epub 2008 Feb 12.
PubMed 18272338Sato FR, Asprino L, de Araujo DE, de Moraes M. Short-term outcome of postoperative patient recovery perception after surgical removal of third molars. J Oral Maxillofac Surg. 2009 May;67(5):1083-91. doi: 10.1016/j.joms.2008.09.032.
PubMed 19375022Markovic A, Todorovic Lj. Effectiveness of dexamethasone and low-power laser in minimizing oedema after third molar surgery: a clinical trial. Int J Oral Maxillofac Surg. 2007 Mar;36(3):226-9. doi: 10.1016/j.ijom.2006.10.006. Epub 2006 Dec 8.
PubMed 17157479Jain N, Maria A. Randomized double blind comparative study on the efficacy of Ibuprofen and aceclofenac in controlling post-operative sequelae after third molar surgery. J Maxillofac Oral Surg. 2011 Jun;10(2):118-22. doi: 10.1007/s12663-011-0198-9. Epub 2011 Apr 22.
PubMed 22654361Agarwal S, Chattopadhyay S, Mandal M. Comparison of efficacy of aceclofenac and ibuprofen after surgical removal of impacted third molar. J. Evolution Med. Dent. Sci. 2017;6(21):1670-1677, DOI: 10.14260/Jemds/2017/368
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preemptive Intravenous Ibuprofen on Postoperative Edema and Trismus in the Third Molar Teeth
- ClinicalTrials.gov ID
- NCT03170713
- Acronym / sponsor ID
- ERZINCAN UNIVERSITY 10
- Keywords
- Preemptive intravenous ibuprofen, trismus, edema, Third molar tooth extraction, Antiinflammatory effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Oct 2017 (estimated)
- Study completion
- 15 Nov 2017 (estimated)
- First posted
- 31 May 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 was planned to investigate the antiinflammatory activity of preemptive intravenous ibuprofen on inflammatory complications such as edema and trismus after third molar tooth surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arveles | Active comparator | Drug: arveles, Drug: intrafen, Other: placebos800 mg ibuprofen and 50 mg arveles in 150 cc normal saline before operation will be given in 30 minutes. |
| intrafen | Active comparator | Drug: arveles, Drug: intrafen, Other: placebosintrafen 800 mg in 150 cc normal saline before operation will be given in 30 minutes. |
| placebos | Placebo comparator | Drug: arveles, Drug: intrafenPre-operative 150 cc normal saline will be delivered in 30 minutes |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Elective 3. Molar tooth extraction
- Patients between the ages of 20-35
- Patients who are symptomatic
- 3. Molar tooth angular or horizontal settled patients
Key exclusion criteria (6 listed)
- Patients who refuse to participate in the study
- Patients under 20 years old, over 35 years old
- Patients who are allergic to known non-steroidal anti-inflammatory drugs
- Pregnant patients
- Patients with severe hepatic insufficiency
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 |
|---|---|---|
| arvelesAlso: dexketoprofen800 mg ibuprofen and 50 mg dexketoprofen in 150 cc normal saline before operation will be given in 30 minutes. The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week. | Drug | arveles, intrafen, placebos |
| intrafenAlso: ibuprofen i.v.800 mg ibuprofen in 150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week. | Drug | arveles, intrafen, placebos |
| placebos150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week. | Other | arveles, intrafen |
Primary outcome
Edema size measured by tape measure method
Time frame: 6 month
the effect of preemptive intravenous ibuprofen on postoperative edema size
1 secondary outcome
Maximum mouth opening measured with vernier caliper
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 16725024Jerjes W, El-Maaytah M, Swinson B, Banu B, Upile T, D'Sa S, Al-Khawalde M, Chaib B, Hopper C. Experience versus complication rate in third molar surgery. Head Face Med. 2006 May 25;2:14. doi: 10.1186/1746-160X-2-14.
- Background: PubMed 18088870Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):117-28, vii. doi: 10.1016/j.coms.2006.11.013.
- Background: PubMed 17694761Chukwuneke F, Onyejiaka N. Management of postoperative morbidity after third molar surgery: a review of the literature. Niger J Med. 2007 Apr-Jun;16(2):107-12. doi: 10.4314/njm.v16i2.37291.
- Background: PubMed 16280233Colorado-Bonnin M, Valmaseda-Castellon E, Berini-Aytes L, Gay-Escoda C. Quality of life following lower third molar removal. Int J Oral Maxillofac Surg. 2006 Apr;35(4):343-7. doi: 10.1016/j.ijom.2005.08.008. Epub 2005 Nov 8.
- Background: PubMed 18296027Vegas-Bustamante E, Mico-Llorens J, Gargallo-Albiol J, Satorres-Nieto M, Berini-Aytes L, Gay-Escoda C. Efficacy of methylprednisolone injected into the masseter muscle following the surgical extraction of impacted lower third molars. Int J Oral Maxillofac Surg. 2008 Mar;37(3):260-3. doi: 10.1016/j.ijom.2007.07.018. Epub 2008 Mar 4.
- Background: PubMed 18272338Chukwuneke FN, Oji C, Saheeb DB. A comparative study of the effect of using a rubber drain on postoperative discomfort following lower third molar surgery. Int J Oral Maxillofac Surg. 2008 Apr;37(4):341-4. doi: 10.1016/j.ijom.2007.11.016. Epub 2008 Feb 12.
- Results publication: PubMed 19375022Sato FR, Asprino L, de Araujo DE, de Moraes M. Short-term outcome of postoperative patient recovery perception after surgical removal of third molars. J Oral Maxillofac Surg. 2009 May;67(5):1083-91. doi: 10.1016/j.joms.2008.09.032.
- Results publication: PubMed 17157479Markovic A, Todorovic Lj. Effectiveness of dexamethasone and low-power laser in minimizing oedema after third molar surgery: a clinical trial. Int J Oral Maxillofac Surg. 2007 Mar;36(3):226-9. doi: 10.1016/j.ijom.2006.10.006. Epub 2006 Dec 8.
- Results publication: PubMed 22654361Jain N, Maria A. Randomized double blind comparative study on the efficacy of Ibuprofen and aceclofenac in controlling post-operative sequelae after third molar surgery. J Maxillofac Oral Surg. 2011 Jun;10(2):118-22. doi: 10.1007/s12663-011-0198-9. Epub 2011 Apr 22.
- Results publicationAgarwal S, Chattopadhyay S, Mandal M. Comparison of efficacy of aceclofenac and ibuprofen after surgical removal of impacted third molar. J. Evolution Med. Dent. Sci. 2017;6(21):1670-1677, DOI: 10.14260/Jemds/2017/368
- Individual participant dataSharing planned: No
Related trials for Trismus
Not yet recruiting
Autologous PRP Versus Triamcinolone Acetate in Patients With Oral Submucous Fibrosis
Oral Submucous Fibrosis
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Swallowing Rehabilitation Program for Head and Neck Tumor Patients
Head and Neck Cancer (H&N)
RecruitingPhase 2
Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies
Throat Carcinoma
Recruiting
Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus
Head and Neck Cancer, Trismus
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.
ilke kupeli principal investigator
Erzincan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arveles and intrafen in people with Trismus and Edema, run by Erzincan University at 1 site in Turkey (Türkiye).
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 4 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: status not confirmed, as of the sponsor's last update on 31 May 2017. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Edema size measured by tape measure method (time frame: 6 month). 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 NCT03170713, which also lists 10 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 31 May 2017.