Impacted Third Molar ToothPhase 4NCT04319978
Dexamethasone Effect on Pain and Edema Following Mandibular 3rd Molar Surgery; Pre-operatively vs Post-operatively
A Phase 4 study testing Dexamethasone injection in people with Impacted Third Molar Tooth, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
TThis is a comparative clinical study which will be conducted in OMFS department of DIKIOHS, DUHS Ojha Karachi. In this study the investigators will be comparing the effect of dexamethasone on pain and edema when administered pre-operatively vs post-operatively following surgery of impacted lower 3rd molars. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Dexamethasone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2020to Nov 2020
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients coming to dental OPD of DIKIOHS, DUHS, Ojha with Mesioangular impactions
- Age of patients: 20-50 years
Who cannot join
- Patients with known co-morbidities
- Patients allergic to dexamethasone
- Patients with history of recent anti-inflammatory drug intake(NSAIDs, steroids, or antihistamines)
- Pregnant/lactating females
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr. Ishrat ul Ebad Khan Institute Of Health Sciences, DUHS, Ojha
Karachi, Sindh, 75330
Arfa Baig, FCPS, 03353046184, arfa_awan@live.com
About this study
Official title: The Effect of IM Dexamethasone Administered Pre-operatively Versus Post-operatively on Pain and Edema Following Surgical Extraction of Mesio-angularly Impacted Mandibular 3 rd Molars
TThis is a comparative clinical study which will be conducted in OMFS department of DIKIOHS, DUHS Ojha Karachi. In this study the investigators will be comparing the effect of dexamethasone on pain and edema when administered pre-operatively vs post-operatively following surgery of impacted lower 3rd molars. Time duration of this study will be 2 months. A total of 100 patients will be considered in this study which will be equally divided into two groups; group A and group B (50 in each group).Group A will receive dexamethasone 1 hour pre-operatively while group B will receive the same post-operatively. All surgeries will be performed by the same maxillofacial surgeon and duration of surgery will be around 30-45 mins.
Read the detailed description
To compare the effect of dexamethasone (IM; 8mg) administered pre-operatively versus post-operatively on pain and edema following surgical extraction of mesio-angularly impacted mandibular 3rd molars.
This is a comparative clinical study. This study will be conducted in Oral Maxillofacial Surgery department of DIKIOHS, DUHS Teaching Hospital, Ojha, Karachi, Pakistan. Time duration of this study will be 2 months. A total of 100 patients will be considered in the study (50 in each group). Sample size was calculated through OpenEpi, taking mean values of post-operative 3rd day swelling (cm) of group A (12.15±0.78), group B (13.85±0.78) [Ref #], 95% confidence interval (two sided) and 80% of the power of the test. The sample size came out to be 8 patients (4 in each group). The sampling technique is Convenience Sampling. Patients will be randomly distributed into two groups; Group A \& Group B. Group A will receive dexamethasone 8mg Intra-muscularly 1 hour pre-operatively while Group B will receive the same immediately after surgery. All surgeries will be performed by the same maxillofacial surgeon and duration of surgery will be around 30-45 minutes.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Dexamethasone injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone injectionDrug
Also called Dexa
Dexamethasone is a synthetic corticosteroid. Dexamethasone is an adequate measure for reducing pain and edema in the post-operative recuperation period following 3rd molar surgery. A single dose of IM 8mg dexamethasone will be used for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will receive single dose of dexamethasone IM 8mg 1 hour pre-operatively. Receives: Drug: Dexamethasone injection |
| Group B | Active comparator | Group B will receive a single dose of dexamethasone IM 8mg immediately after surgery. Receives: Drug: Dexamethasone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Edema of face in the mandibular region
edema will be assessed using a measuring tape in three facial planes (M1,M2,M3) M1: Tragus of Ear to Corner of Mouth M2: Tragus of Ear to Pogonion M3: Lateral Canthus of Eye to Angle of Mandible.
Measured: Change in edema will be assessed from baseline at 1st, 3rd and 7th day post-operatively
Secondary outcomes (1)
Change in Intensity of Pain in the extracted site: Visual Analog Scale (VAS)
Pain will be assessed using Visual Analog Scale (VAS). VAS is a psychometric response scale which can be used as a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. It is graded from 0 to 10; 0 indicating "No pain" while 10 indicating "excruciating/ unbearable pain"
Measured: Change in the intensity of pain will be assessed from baseline to 1st, 3rd and 7th day post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study startJul 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionNov 2020 (estimated)
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A total of 100 patients will be considered in this study which will be equally divided into two groups; group A and group B (50 in each group).Group A will receive dexamethasone 1 hour pre-operatively while group B will receive the same post-operatively.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arfa baig, Dow University of Health Sciences
- Investigators
- Arfa Baig, FCPS, Principal investigator, DIKIOHS, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319978
- Sponsor's protocol ID
- 92 (308) 4448862
- Status last verified
- Jun 2020
- First submitted
- 19 Mar 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of IM Dexamethasone Administered Pre-operatively Versus Post-operatively on Pain and Edema Following Surgical Extraction of Mesio-angularly Impacted Mandibular 3 rd Molars
- ClinicalTrials.gov ID
- NCT04319978
- Acronym / sponsor ID
- 92 (308) 4448862
- Conditions
- Impacted Third Molar Tooth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 24 Mar 2020 (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.
TThis is a comparative clinical study which will be conducted in OMFS department of DIKIOHS, DUHS Ojha Karachi. In this study the investigators will be comparing the effect of dexamethasone on pain and edema when administered pre-operatively vs post-operatively following surgery of impacted lower 3rd molars. Time duration of this study will be 2 months. A total of 100 patients will be considered in this study which will be equally divided into two groups; group A and group B (50 in each group).Group A will receive dexamethasone 1 hour pre-operatively while group B will receive the same post-operatively. All surgeries will be performed by the same maxillofacial surgeon and duration of surgery will be around 30-45 mins.
Detailed description
To compare the effect of dexamethasone (IM; 8mg) administered pre-operatively versus post-operatively on pain and edema following surgical extraction of mesio-angularly impacted mandibular 3rd molars.
This is a comparative clinical study. This study will be conducted in Oral Maxillofacial Surgery department of DIKIOHS, DUHS Teaching Hospital, Ojha, Karachi, Pakistan. Time duration of this study will be 2 months. A total of 100 patients will be considered in the study (50 in each group). Sample size was calculated through OpenEpi, taking mean values of post-operative 3rd day swelling (cm) of group A (12.15±0.78), group B (13.85±0.78) [Ref #], 95% confidence interval (two sided) and 80% of the power of the test. The sample size came out to be 8 patients (4 in each group). The sampling technique is Convenience Sampling. Patients will be randomly distributed into two groups; Group A \& Group B. Group A will receive dexamethasone 8mg Intra-muscularly 1 hour pre-operatively while Group B will receive the same immediately after surgery. All surgeries will be performed by the same maxillofacial surgeon and duration of surgery will be around 30-45 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 100 patients will be considered in this study which will be equally divided into two groups; group A and group B (50 in each group).Group A will receive dexamethasone 1 hour pre-operatively while group B will receive the same post-operatively.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexamethasone injectionGroup A will receive single dose of dexamethasone IM 8mg 1 hour pre-operatively. |
| Group B | Active comparator | Drug: Dexamethasone injectionGroup B will receive a single dose of dexamethasone IM 8mg immediately after surgery. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients coming to dental OPD of DIKIOHS, DUHS, Ojha with Mesioangular impactions
- Age of patients: 20-50 years
Key exclusion criteria (4 listed)
- Patients with known co-morbidities
- Patients allergic to dexamethasone
- Patients with history of recent anti-inflammatory drug intake(NSAIDs, steroids, or antihistamines)
- Pregnant/lactating females
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 |
|---|---|---|
| Dexamethasone injectionAlso: DexaDexamethasone is a synthetic corticosteroid. Dexamethasone is an adequate measure for reducing pain and edema in the post-operative recuperation period following 3rd molar surgery. A single dose of IM 8mg dexamethasone will be used for each patient. | Drug | Group A, Group B |
Primary outcome
Change in Edema of face in the mandibular region
Time frame: Change in edema will be assessed from baseline at 1st, 3rd and 7th day post-operatively
edema will be assessed using a measuring tape in three facial planes (M1,M2,M3) M1: Tragus of Ear to Corner of Mouth M2: Tragus of Ear to Pogonion M3: Lateral Canthus of Eye to Angle of Mandible.
1 secondary outcome
Change in Intensity of Pain in the extracted site: Visual Analog Scale (VAS)
Time frame: Change in the intensity of pain will be assessed from baseline to 1st, 3rd and 7th day post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Impacted Third Molar Tooth
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
RecruitingObservational study
Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
Stomatognatic, Tooth Diseases
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing
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.
Arfa Baig, FCPS principal investigator
DIKIOHS, DUHS
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 Dexamethasone injection in people with Impacted Third Molar Tooth, run by Dow University of Health Sciences at 1 site in Pakistan.
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 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. 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 Pakistan. 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 Arfa Baig, FCPS (03353046184, arfa_awan@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Edema of face in the mandibular region (time frame: Change in edema will be assessed from baseline at 1st, 3rd and 7th day post-operatively). 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 9 Jun 2020.