Effect of DrugEarly Phase 1NCT05142098
Comparison of the Anti-Inflammatory Efficacy of Preemptive Dexamethasone and Etoricoxib
A Early Phase 1 study testing Dexamethasone and Etoricoxib 60 mg in people with Effect of Drug, run by Dow University of Health Sciences.
Trial summary
Impaction of mandibular third molars is a commonly encountered problem in oral surgery; patients frequently visit dental OPDs with complains related to the impacted molars, and in almost all situations, surgical removal of these impactions is the definitive treatment provided to such patients. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Dexamethasone and Etoricoxib 60 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Aug 2022
- Phase
- Early Phase 1
- 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
- Age 18-35 years.
- Absence of any systemic disease.
- Mandibular third molars in similar position with similar root formation.
- 3. No use of any medication in last 03 days. 4. Absence of allergy to any drug used in the study. 5. Surgical site with no current signs or symptoms of infection.
Who cannot join
- Pregnancy or lactation.
- History of gastrointestinal bleeding or peptic ulcer.
- Current smoking habit.
- Patient encountering any complication during/after procedure.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Anti-Inflammatory Efficacy of Preemptive Dexamethasone and Etoricoxib Following Impacted Third Molar Surgery
Impaction of mandibular third molars is a commonly encountered problem in oral surgery; patients frequently visit dental OPDs with complains related to the impacted molars, and in almost all situations, surgical removal of these impactions is the definitive treatment provided to such patients. This type of surgery often involves osteotomies and tooth sectioning, that initiates acute inflammatory responses which results in significant amount of postoperative discomfort owing to the associated pain, swelling and trismus; which considerably affects the quality of life that may span from days up to weeks in few instances. In the past decades, different group of medications have been used to counter these adverse postoperative sequelae, such as steroidal anti-inflammatory drugs (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs).
MATERIAL AND METHODS:
Read more
Study design: Randomized, double-blind, clinical trial with a split-mouth design.
Setting: The study would be conducted at Oral \& Maxillofacial Surgery department, Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi.
Duration of study: Six months after the approval of synopsis. Sample size: A total of 170 patients would be included in the study, i.e. 85 in each group with 2 patients as a drop out.
Calculated sample size is 83 patients per group; utilizing Pass version 11 software with 95% confidence interval, mean ± S.D of swelling in dexamethasone group1 95.7 ± 11.1 and in etoricoxib group1 100.0 ± 8.3 at measurement 5.
Sampling technique: Purposive non-probability sampling technique would be used for the selection of patients.
Sample selection: Patients meeting the following criteria would be included in the study: 1. Age 18-35 years. 2. Absence of any systemic disease. 3. Mandibular third molars in similar position with similar root formation. 3. No use of any medication in last 03 days. 4. Absence of allergy to any drug used in the study. 5. Surgical site with no current signs or symptoms of infection.
Patients meeting any of the following criteria would be excluded from the study: 1. Pregnancy or lactation. 2. History of gastrointestinal bleeding or peptic ulcer. 3. Current smoking habit.
Read the detailed description
Impaction of mandibular third molars is a commonly encountered problem in oral surgery; patients frequently visit dental OPDs with complains related to the impacted molars, and in almost all situations, surgical removal of these impactions is the definitive treatment provided to such patients. This type of surgery often involves osteotomies and tooth sectioning, that initiates acute inflammatory responses which results in significant amount of postoperative discomfort owing to the associated pain, swelling and trismus; which considerably affects the quality of life that may span from days up to weeks in few instances. In the past decades, different group of medications have been used to counter these adverse postoperative sequelae, such as steroidal anti-inflammatory drugs (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs).
Owing to its predominant glucocorticosteroid effects, minimal sodium retention activity and long half-life, dexamethasone remains the most popular drug used in third molar surgery. And with the advantages of fewer gastrointestinal side effects, not disturbing platelet function and being well tolerated, the selective COX-2 inhibitor, Etoricoxib, is a suitable analgesic for the treatment of acute pain.
Lima et al2 concluded in their study that preemptive administration of dexamethasone showed better control of pain and swelling following impacted third molar extraction. Gaetano et al3 showed a greater reduction in incidence and severity of postoperative pain treated with etoricoxib compared with diclofenac, in impacted third molar surgery. Despite a lot of research related to the efficacy of dexamethasone and etoricoxib as preemptive drugs in controlling the postoperative sequelae, there is a negligible amount of research material available comparing the efficacy of these two anti-inflammatory drugs, therefore, the purpose of this study is to compare the preemptive anti-inflammatory effects of dexamethasone administered intramuscularly into the medial pterygoid muscle immediately after local anesthesia, with Etroicoxib given orally 1 hour prior to the surgery.
RATIONALE:
This study would help the clinicians in better understanding the anti-inflammatory consequences associated with a common oral surgical procedure. The results of this study would greatly enhance understanding about which drug to prescribe for the better control of anti-inflammatory sequelae of impacted third molar surgery, thereby, avoiding unnecessary drug prescriptions which would be ultimately beneficial for the patient undergoing treatment.
OBJECTIVE: The purpose of this study is to compare the preemptive anti-inflammatory efficacy of dexamethasone administered intramuscularly with etoricoxib given orally, following the impacted third molar surgery.
MATERIAL AND METHODS:
Study design: Randomized, double-blind, clinical trial with a split-mouth design.
Setting: The study would be conducted at Oral \& Maxillofacial Surgery department, Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi.
Duration of study: Six months after the approval of synopsis. Sample size: A total of 170 patients would be included in the study, i.e. 85 in each group with 2 patients as a drop out.
Calculated sample size is 83 patients per group; utilizing Pass version 11 software with 95% confidence interval, mean ± S.D of swelling in dexamethasone group1 95.7 ± 11.1 and in etoricoxib group1 100.0 ± 8.3 at measurement 5.
Sampling technique: Purposive non-probability sampling technique would be used for the selection of patients.
Sample selection: Patients meeting the following criteria would be included in the study: 1. Age 18-35 years. 2. Absence of any systemic disease. 3. Mandibular third molars in similar position with similar root formation. 3. No use of any medication in last 03 days. 4. Absence of allergy to any drug used in the study. 5. Surgical site with no current signs or symptoms of infection.
Patients meeting any of the following criteria would be excluded from the study: 1. Pregnancy or lactation. 2. History of gastrointestinal bleeding or peptic ulcer. 3. Current smoking habit.
- Conditions
- Effect of Drug
- Being tested
- Dexamethasone, Etoricoxib 60 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Glucocorticoid
Intramuscular
Etoricoxib 60 mgDrug
Also called Cox-2 Inhibitor
Orally
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Dexamethasone 4mg will be injected intramuscularly into the pterygomandibular space after achieving effective inferior dental block. Receives: Drug: Dexamethasone |
| Etoricoxib | Experimental | 2 tablets 60mg each would be given orally one hour prior to the surgery. Receives: Drug: Etoricoxib 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of post operative complications after dexamethasone
dexamethasone is more effective in controlling post operative pain, swelling and trismus following impacted third molar surgery.
Measured: within one week after procedure
assessment of post operative complications after etoricoxib
Etoricoxib is more effective in controlling post operative pain, swelling and trismus following impacted third molar surgery.
Measured: within one week after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Hafeez, Dow University of Health Sciences
- Investigators
- hassan hafeez, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142098
- Sponsor's protocol ID
- hassan321
- Status last verified
- Dec 2021
- First submitted
- 21 Oct 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Anti-Inflammatory Efficacy of Preemptive Dexamethasone and Etoricoxib Following Impacted Third Molar Surgery
- ClinicalTrials.gov ID
- NCT05142098
- Acronym / sponsor ID
- hassan321
- Conditions
- Effect of Drug
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 2 Dec 2021 (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.
Impaction of mandibular third molars is a commonly encountered problem in oral surgery; patients frequently visit dental OPDs with complains related to the impacted molars, and in almost all situations, surgical removal of these impactions is the definitive treatment provided to such patients. This type of surgery often involves osteotomies and tooth sectioning, that initiates acute inflammatory responses which results in significant amount of postoperative discomfort owing to the associated pain, swelling and trismus; which considerably affects the quality of life that may span from days up to weeks in few instances. In the past decades, different group of medications have been used to counter these adverse postoperative sequelae, such as steroidal anti-inflammatory drugs (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs).
MATERIAL AND METHODS:
Study design: Randomized, double-blind, clinical trial with a split-mouth design.
Setting: The study would be conducted at Oral \& Maxillofacial Surgery department, Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi.
Duration of study: Six months after the approval of synopsis. Sample size: A total of 170 patients would be included in the study, i.e. 85 in each group with 2 patients as a drop out.
Calculated sample size is 83 patients per group; utilizing Pass version 11 software with 95% confidence interval, mean ± S.D of swelling in dexamethasone group1 95.7 ± 11.1 and in etoricoxib group1 100.0 ± 8.3 at measurement 5.
Sampling technique: Purposive non-probability sampling technique would be used for the selection of patients.
Sample selection: Patients meeting the following criteria would be included in the study: 1. Age 18-35 years. 2. Absence of any systemic disease. 3. Mandibular third molars in similar position with similar root formation. 3. No use of any medication in last 03 days. 4. Absence of allergy to any drug used in the study. 5. Surgical site with no current signs or symptoms of infection.
Patients meeting any of the following criteria would be excluded from the study: 1. Pregnancy or lactation. 2. History of gastrointestinal bleeding or peptic ulcer. 3. Current smoking habit.
Detailed description
Impaction of mandibular third molars is a commonly encountered problem in oral surgery; patients frequently visit dental OPDs with complains related to the impacted molars, and in almost all situations, surgical removal of these impactions is the definitive treatment provided to such patients. This type of surgery often involves osteotomies and tooth sectioning, that initiates acute inflammatory responses which results in significant amount of postoperative discomfort owing to the associated pain, swelling and trismus; which considerably affects the quality of life that may span from days up to weeks in few instances. In the past decades, different group of medications have been used to counter these adverse postoperative sequelae, such as steroidal anti-inflammatory drugs (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs).
Owing to its predominant glucocorticosteroid effects, minimal sodium retention activity and long half-life, dexamethasone remains the most popular drug used in third molar surgery. And with the advantages of fewer gastrointestinal side effects, not disturbing platelet function and being well tolerated, the selective COX-2 inhibitor, Etoricoxib, is a suitable analgesic for the treatment of acute pain.
Lima et al2 concluded in their study that preemptive administration of dexamethasone showed better control of pain and swelling following impacted third molar extraction. Gaetano et al3 showed a greater reduction in incidence and severity of postoperative pain treated with etoricoxib compared with diclofenac, in impacted third molar surgery. Despite a lot of research related to the efficacy of dexamethasone and etoricoxib as preemptive drugs in controlling the postoperative sequelae, there is a negligible amount of research material available comparing the efficacy of these two anti-inflammatory drugs, therefore, the purpose of this study is to compare the preemptive anti-inflammatory effects of dexamethasone administered intramuscularly into the medial pterygoid muscle immediately after local anesthesia, with Etroicoxib given orally 1 hour prior to the surgery.
RATIONALE:
This study would help the clinicians in better understanding the anti-inflammatory consequences associated with a common oral surgical procedure. The results of this study would greatly enhance understanding about which drug to prescribe for the better control of anti-inflammatory sequelae of impacted third molar surgery, thereby, avoiding unnecessary drug prescriptions which would be ultimately beneficial for the patient undergoing treatment.
OBJECTIVE: The purpose of this study is to compare the preemptive anti-inflammatory efficacy of dexamethasone administered intramuscularly with etoricoxib given orally, following the impacted third molar surgery.
MATERIAL AND METHODS:
Study design: Randomized, double-blind, clinical trial with a split-mouth design.
Setting: The study would be conducted at Oral \& Maxillofacial Surgery department, Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi.
Duration of study: Six months after the approval of synopsis. Sample size: A total of 170 patients would be included in the study, i.e. 85 in each group with 2 patients as a drop out.
Calculated sample size is 83 patients per group; utilizing Pass version 11 software with 95% confidence interval, mean ± S.D of swelling in dexamethasone group1 95.7 ± 11.1 and in etoricoxib group1 100.0 ± 8.3 at measurement 5.
Sampling technique: Purposive non-probability sampling technique would be used for the selection of patients.
Sample selection: Patients meeting the following criteria would be included in the study: 1. Age 18-35 years. 2. Absence of any systemic disease. 3. Mandibular third molars in similar position with similar root formation. 3. No use of any medication in last 03 days. 4. Absence of allergy to any drug used in the study. 5. Surgical site with no current signs or symptoms of infection.
Patients meeting any of the following criteria would be excluded from the study: 1. Pregnancy or lactation. 2. History of gastrointestinal bleeding or peptic ulcer. 3. Current smoking habit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneDexamethasone 4mg will be injected intramuscularly into the pterygomandibular space after achieving effective inferior dental block. |
| Etoricoxib | Experimental | Drug: Etoricoxib 60 mg2 tablets 60mg each would be given orally one hour prior to the surgery. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-35 years.
- Absence of any systemic disease.
- Mandibular third molars in similar position with similar root formation.
- 3. No use of any medication in last 03 days. 4. Absence of allergy to any drug used in the study. 5. Surgical site with no current signs or symptoms of infection.
Key exclusion criteria (4 listed)
- Pregnancy or lactation.
- History of gastrointestinal bleeding or peptic ulcer.
- Current smoking habit.
- Patient encountering any complication during/after procedure.
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 |
|---|---|---|
| DexamethasoneAlso: GlucocorticoidIntramuscular | Drug | Dexamethasone |
| Etoricoxib 60 mgAlso: Cox-2 InhibitorOrally | Drug | Etoricoxib |
Primary outcome
assessment of post operative complications after dexamethasone
Time frame: within one week after procedure
dexamethasone is more effective in controlling post operative pain, swelling and trismus following impacted third molar surgery.
assessment of post operative complications after etoricoxib
Time frame: within one week after procedure
Etoricoxib is more effective in controlling post operative pain, swelling and trismus following impacted third molar surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
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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.
hassan hafeez principal investigator
DUHS
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone and Etoricoxib 60 mg in people with Effect of Drug, run by Dow University of Health Sciences.
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 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 HASSAN HAFEEZ (03332726607, hassankhandentist@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of post operative complications after dexamethasone (time frame: within one week after procedure). 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?
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 16 Dec 2021.