Impacted Third Molar ToothPhase 4NCT02416869
Dexamethasone in Lower Third Molar Surgery
A Phase 4 study testing Intramuscular application, Submucosal application and 4mg Dexamethasone submucosal in people with Impacted Third Molar Tooth, run by University of Belgrade at 1 site in Serbia.
Trial summary
The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Intramuscular application, Submucosal application and 4mg Dexamethasone submucosal
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- Jan 2014to Apr 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy patients (ASA I)
- Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification
Who cannot join
- Heavy tobacco smokers
- Drug and / or alcohol abusers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery
The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Intramuscular application, Submucosal application, 4mg Dexamethasone submucosal, 8mg Dexamethasone submucosal, 4mg Dexamethasone preoperative
- Keywords
- Dexamethasone, Lower third molar surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular applicationProcedure or surgery
Patient receive 4mg of Dexamethasone by intramuscular application
Submucosal applicationProcedure or surgery
Patients receive 4mg of Dexamethasone by submucosal application
4mg Dexamethasone submucosalDrug
Also called Dexasone
Patients receive 4mg of submucosal Dexamethasone
8mg Dexamethasone submucosalDrug
Also called Dexasone
Patients receive 8mg of submucosal Dexamethasone
4mg Dexamethasone preoperativeProcedure or surgery
Patients receive 4mg of Dexamethasone preoperatively
4mg Dexamethasone postoperativeProcedure or surgery
Patients receive 4mg of Dexamethasone postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular application | Active comparator | Intramuscular application of 4mg Dexamethasone Receives: Procedure: Intramuscular application |
| Submucosal application | Experimental | Submucosal application of 4mg Dexamethasone Receives: Procedure: Submucosal application |
| 4mg Dexamethasone submucosal | Active comparator | 4mg Dexamethasone submucosal application Receives: Drug: 4mg Dexamethasone submucosal |
| 8mg Dexamethasone submucosal | Experimental | 8mg Dexamethasone submucosal application Receives: Drug: 8mg Dexamethasone submucosal |
| 4mg Dexamethasone postoperative | Active comparator | 4mg Dexamethasone postoperative application Receives: Procedure: 4mg Dexamethasone preoperative |
| 4mg Dexamethasone preoperative | Experimental | 4mg Dexamethasone postoperative application Receives: Procedure: 4mg Dexamethasone postoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial swelling (using 3 facial measurements (in millimeters)
We followed facial swelling 1, 3 and 7 days after intervention.
Swelling in the operation site will be evaluated using 3 facial measurements (in millimeters):
- Tragus - Midline.
- Tragus - Corner of the mouth
- Gonion - Lateral canthus.
Measured: 1 day, 3 day, 7 day
Secondary outcomes (3)
Postoperative pain (visual analog scale)
Postoperative pain will be evaluated using a visual analog scale, 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain".
Measured: 1 day, 3 day, 7 day
Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery.
Measured: 1 day, 3 day, 7 day
Postoperative discomfort (25-items custom made questionnaire)
Postoperative discomfort will be evaluated by filling out the 25-items custom made questionnaire that was designed to asses the patient's perception of adverse effects.
Measured: 4 day, 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miroslav Andric, University of Belgrade
- Investigators
- Miroslav M Andric, DDS, PhD, Principal investigator, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416869
- Sponsor's protocol ID
- 36/11-2013
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2015
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery
- ClinicalTrials.gov ID
- NCT02416869
- Acronym / sponsor ID
- 36/11-2013
- Conditions
- Impacted Third Molar Tooth
- Keywords
- Dexamethasone, Lower third molar surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 15 Apr 2015 (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 randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Intramuscular application | Active comparator | Procedure: Intramuscular applicationIntramuscular application of 4mg Dexamethasone |
| Submucosal application | Experimental | Procedure: Submucosal applicationSubmucosal application of 4mg Dexamethasone |
| 4mg Dexamethasone submucosal | Active comparator | Drug: 4mg Dexamethasone submucosal4mg Dexamethasone submucosal application |
| 8mg Dexamethasone submucosal | Experimental | Drug: 8mg Dexamethasone submucosal8mg Dexamethasone submucosal application |
| 4mg Dexamethasone postoperative | Active comparator | Procedure: 4mg Dexamethasone preoperative4mg Dexamethasone postoperative application |
| 4mg Dexamethasone preoperative | Experimental | Procedure: 4mg Dexamethasone postoperative4mg Dexamethasone postoperative application |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy patients (ASA I)
- Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification
Key exclusion criteria (2 listed)
- Heavy tobacco smokers
- Drug and / or alcohol abusers
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 |
|---|---|---|
| Intramuscular applicationPatient receive 4mg of Dexamethasone by intramuscular application | Procedure or surgery | Intramuscular application |
| Submucosal applicationPatients receive 4mg of Dexamethasone by submucosal application | Procedure or surgery | Submucosal application |
| 4mg Dexamethasone submucosalAlso: DexasonePatients receive 4mg of submucosal Dexamethasone | Drug | 4mg Dexamethasone submucosal |
| 8mg Dexamethasone submucosalAlso: DexasonePatients receive 8mg of submucosal Dexamethasone | Drug | 8mg Dexamethasone submucosal |
| 4mg Dexamethasone preoperativePatients receive 4mg of Dexamethasone preoperatively | Procedure or surgery | 4mg Dexamethasone postoperative |
| 4mg Dexamethasone postoperativePatients receive 4mg of Dexamethasone postoperatively | Procedure or surgery | 4mg Dexamethasone preoperative |
Primary outcome
Facial swelling (using 3 facial measurements (in millimeters)
Time frame: 1 day, 3 day, 7 day
We followed facial swelling 1, 3 and 7 days after intervention. Swelling in the operation site will be evaluated using 3 facial measurements (in millimeters): 1. Tragus - Midline. 2. Tragus - Corner of the mouth 3. Gonion - Lateral canthus.
3 secondary outcomes
Postoperative pain (visual analog scale)
Time frame: 1 day, 3 day, 7 day
Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
Time frame: 1 day, 3 day, 7 day
Postoperative discomfort (25-items custom made questionnaire)
Time frame: 4 day, 7 day
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 22 Apr 2019.
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Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
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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.
Miroslav M Andric, DDS, PhD principal investigator
University of Zagreb
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 Intramuscular application, Submucosal application and 4mg Dexamethasone submucosal in people with Impacted Third Molar Tooth, run by University of Belgrade at 1 site in Serbia.
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 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 22 Apr 2019. 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 Serbia. 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?
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?
Facial swelling (using 3 facial measurements (in millimeters) (time frame: 1 day, 3 day, 7 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 22 Apr 2019.