Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05142098 |
| Other study ID # |
hassan321 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
August 1, 2022 |
Study information
| Verified date |
December 2021 |
| Source |
Dow University of Health Sciences |
| Contact |
HASSAN HAFEEZ |
| Phone |
03332726607 |
| Email |
hassankhandentist[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
