Professor. Dr. Md. Abu Saeed Ibn Harun
Chittagong, Chattogram, 4212, Bangladesh
Location status: Recruiting
Location contact
Mohammad Kamrul Islam, FCPS
CONTACT
Prof. Dr. Md. Abu Saeed Ibn Harun, MS
CONTACT
Suparna Das, BDs
SUB_INVESTIGATOR
NCT Number: NCT07400471
A clinical trial comparing preemptive multimodal analgesics with placebo in the management of immediate and chronic post-endodontic pain. The study utilizes statistical methods such as chi-squared, T-tests, and regression analysis, accounting for multiple outcomes with the Bonferroni adjustment. Duloxetine hydrochloride and pregabalin, both available in Bangladesh, are evaluated as experimental drugs, while placebos are used to assess psychological effects on pain. All participants receive standard interventional treatments, with acetaminophen provided as needed, and ethical considerations are addressed according to international guidelines.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Chittagong, Chattogram, 4212, Bangladesh
Location status: Recruiting
Mohammad Kamrul Islam, FCPS
CONTACT
Prof. Dr. Md. Abu Saeed Ibn Harun, MS
CONTACT
Suparna Das, BDs
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preemptive Multi modal analgesic drug: Experimental group will be divided into 2 subgroups according to use of drug.
A. Pregabalin-acetaminophen. B. Duloxetine-Acetaminophen Pregabalin-acetaminophen: Before a half-hour endodontic treatment, patients in this group will receive a single dosage of 50 mg pregabalin and 500 mg acetaminophen. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.
Duloxetine-Acetaminophen: Prior to a half-hour endodontic treatment, patients in this group will receive a single dosage of 500 mg of acetaminophen and 30 mg of Duloxetine. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.
Time frame: 6, 12, 24, 48, 72 hours
Primary Pain during endodontic treatment and the effectiveness of intervention will be evaluated at 6, 12, 24, 48, 72, and hourly intervals after the endodontic procedure. Treatment-related anaesthetic efficacy will be assessed using the VAS (Visual Analogue Scale; numerical value 0-10). During endodontic treatment, the level of pain will decide how effective the anesthetic is. The patient will be asked to rate the analgesic effects on a VAS (Visual Analogue Scale) scale by providing a numerical number 0-10. '0" are indicated no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= sever pain.
Time frame: baseline, 72 hours
Mechanical Detection Threshold: A standardized set of modified von Frey hairs (Opti-hair2-Set, Marstock Nervtest, Germany) that exert stresses upon bending between 0.25 and 512 mN graded by a factor of 2 (1-2 s contact time) were used to determine the mechanical detection threshold (MDT). With a rounded tip and 0.5 mm in diameter, the von Frey hairs' contact area with the skin was consistent in size and shape to prevent sharp edges that could aid in nociceptor activation. Five threshold determinations with a sequence of increasing and decreasing stimulus intensities were made using the "method of limits." The geometric mean of these five series served as the final threshold.
Time frame: baseline, 72 hours
Mechanical Pain Threshold: A set of seven pin-prick mechanical stimulators with preset stimulus intensities (flat contact area of 0.2 mm diameter) that applied forces of 8, 16, 32, 64, 128, 256, and 512 mN were used to test the mechanical pain threshold (MPT). These stimuli were custom-made and weighted. Until the first perception of sharpness was attained, the stimulators were applied in ascending order at a pace of two seconds on, two seconds off. The geometric mean of five sequences of rising and descending stimuli served as the final threshold. The purpose of this test was to identify pinprick hypoalgesia. Before initiation of endodontic treatment, the patient has to take drug that's are supplied in enveloped.
Time frame: baseline, 72 hours
Mechanical Pain Sensitivity will test using the same weighted pinprick stimuli as for mechanical pain threshold. To obtain a stimulus- response- function, these seven pinprick stimuli will apply in a balanced order, five times each, and patient will ask to give a pain rating for each stimulus on a 0-10 VAS scale ( '0' indicate no pain; 10 indicate most intense pain imaginable.
Contact information is provided by the study sponsor or research team.
Chattogram International Dental College
Other
The Effects of Preemptive Multimodal Analgesic on Endodontic Pain.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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