Oral HealthPhase 4NCT01896427
Comparing Pain and Swelling After Surgical Extraction of Mandibular Third Molar in Dexamethasone Injection and Without Corticosteroid Methods
A Phase 4 study testing 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione in people with Oral Health and Molar, Third, run by Mohammad Javad Shirani at 1 site in Iran.
Trial summary
In some cases, impacted wisdom teeth should be extracted. Surgical extraction of these impacted third molars may provide special complication as pain, swelling, and trismus. In previous studies, some techniques as sutureless flap closure, modified flap designing, antibiotic usage, and injection of corticosteroids were… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Molar, Third
- What is being tested?
- 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIran
- Study dates
- Apr 2013to Apr 2014
- Phase
- Phase 4
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner
- They must have no contra-indication for injection of the corticosteroid and lidocaine with epinephrine
- Should not medicated by any possibly bias maker drug
- Type of the impaction, must not provide sever difficulty
- The participants should be mentally at healthy level and provide written informed consent to incorporate in the study
Who cannot join
- -Unwilling participants to continue the study and those with abnormality of wound healing process
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
Isfahan, Isfahan, 81745-319
Mohammadjavad Shirani, Dr, 00989356039479, javaad.sh_f@yahoo.com
Mohammadjavad Shirani, Dr
About this study
In some cases, impacted wisdom teeth should be extracted. Surgical extraction of these impacted third molars may provide special complication as pain, swelling, and trismus. In previous studies, some techniques as sutureless flap closure, modified flap designing, antibiotic usage, and injection of corticosteroids were presented. These methods are reducing post operative complications to moderate level. In this study, pain, swelling, trismus, general patients' satisfaction, and associated quality of life after the surgical removal of third mandibular impacted molars will be compared while injection of dexamethasone (8mg) does not need excessive time, effort, and equipments and it will be injected in numbness area into medial pterygoid muscle and pterygomandibular space to current corticosteroid injecting non-corticosteroid methods. To achieve this aim, 75 non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner, after provision of written informed consent will be entered to the study. During the study, unwilling participants to continue the study and those with abnormality of wound healing process will be excluded. The included participants will be assigned into three 25-people groups. The surgeries were done by 3 same instructed experienced oral and maxillofacial residents. After the surgery pain, swelling, trismus, general patients' satisfaction, and associated quality of life were evaluated using interview of questionnaire in 48 hour, 96 hour, and one week period of time. The comparison was done between these three groups.
- Conditions
- Oral Health, Molar, Third
- Being tested
- 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione
- Keywords
- Third Molar, Edema, pain, trismus
- Medical subject headings
- Edema, Pain, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dioneDrug
single dose of dexamethasone (8mg) will injected
| Study group | Role | What they receive |
|---|---|---|
| Dexamethazone IO | Active comparator | For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space Receives: Drug: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione |
| Dexamethasone IM | Active comparator | For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space Receives: Drug: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain
Visual analogue scale of pain- Number of required analgesics tablets
Measured: 48 hours and one week after intervention
Changes in Swelling
Questionnaire and VAS
Measured: 48 hours and one week after intervention
Changes in Trismus
Questionnaire
Measured: 48 hours and one week after intervention
Changes in General patients' satisfaction
Visual analogue scale for satisfaction
Measured: 48 hours and one week after intervention
Changes in Quality of life
Questionnaire
Measured: 96 hours and one week after intervention
Secondary outcomes (1)
Trismus
Questionnaire about Maximum mouth opening- Patients complaint
Measured: one week period after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammad Javad Shirani
- Sponsor type
- University, hospital or other
- Collaborators
- Isfahan University of Medical Sciences
- Responsible party
- Sponsor-investigator, Mohammad Javad Shirani, Isfahan University of Medical Sciences
- Investigators
- Bijan Movahedian, Oral and maxillofacial surgeon, Study chair, Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896427
- Sponsor's protocol ID
- 292037
- Other IDs
- 292037, IRCT2013042713140N1
- Status last verified
- Jul 2013
- First submitted
- 30 Jun 2013
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Pain and Swelling After Surgical Extraction of Mandibular Third Molar in Dexamethasone Injection and Without Corticosteroid Methods
- ClinicalTrials.gov ID
- NCT01896427
- Acronym / sponsor ID
- 292037
- Conditions
- Oral Health, Molar, Third
- Keywords
- Third Molar, Edema, pain, trismus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mohammad Javad ShiraniUniversity, hospital or other
- Collaborators
- Isfahan University of Medical Sciences
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- First posted
- 11 Jul 2013 (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.
In some cases, impacted wisdom teeth should be extracted. Surgical extraction of these impacted third molars may provide special complication as pain, swelling, and trismus. In previous studies, some techniques as sutureless flap closure, modified flap designing, antibiotic usage, and injection of corticosteroids were presented. These methods are reducing post operative complications to moderate level. In this study, pain, swelling, trismus, general patients' satisfaction, and associated quality of life after the surgical removal of third mandibular impacted molars will be compared while injection of dexamethasone (8mg) does not need excessive time, effort, and equipments and it will be injected in numbness area into medial pterygoid muscle and pterygomandibular space to current corticosteroid injecting non-corticosteroid methods. To achieve this aim, 75 non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner, after provision of written informed consent will be entered to the study. During the study, unwilling participants to continue the study and those with abnormality of wound healing process will be excluded. The included participants will be assigned into three 25-people groups. The surgeries were done by 3 same instructed experienced oral and maxillofacial residents. After the surgery pain, swelling, trismus, general patients' satisfaction, and associated quality of life were evaluated using interview of questionnaire in 48 hour, 96 hour, and one week period of time. The comparison was done between these three groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethazone IO | Active comparator | Drug: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dioneFor the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space |
| Dexamethasone IM | Active comparator | Drug: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dioneFor the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner
- They must have no contra-indication for injection of the corticosteroid and lidocaine with epinephrine
- Should not medicated by any possibly bias maker drug
- Type of the impaction, must not provide sever difficulty
- The participants should be mentally at healthy level and provide written informed consent to incorporate in the study
Key exclusion criteria (1 listed)
- -Unwilling participants to continue the study and those with abnormality of wound healing process
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 |
|---|---|---|
| 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dionesingle dose of dexamethasone (8mg) will injected | Drug | Dexamethasone IM, Dexamethazone IO |
Primary outcome
Changes in Pain
Time frame: 48 hours and one week after intervention
Visual analogue scale of pain- Number of required analgesics tablets
Changes in Swelling
Time frame: 48 hours and one week after intervention
Questionnaire and VAS
Changes in Trismus
Time frame: 48 hours and one week after intervention
Questionnaire
Changes in General patients' satisfaction
Time frame: 48 hours and one week after intervention
Visual analogue scale for satisfaction
Changes in Quality of life
Time frame: 96 hours and one week after intervention
Questionnaire
1 secondary outcome
Trismus
Time frame: one week period after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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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.
Bijan Movahedian, Oral and maxillofacial surgeon study chair
Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
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 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione in people with Oral Health and Molar, Third, run by Mohammad Javad Shirani at 1 site in Iran.
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 5 inclusion and 1 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 11 Jul 2013. 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 Iran. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammadjavad Shirani, Dr (00989356039479, javaad.sh_f@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain (time frame: 48 hours and one week after intervention). The study lists 5 primary outcomes in all. 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 11 Jul 2013.