Soft Tissue Injuries Clinical Trial
Official title:
A Randomized Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Decreasing Self- Inflicted Soft Tissue Trauma Following Local Anaesthesia Injection for Dental Procedure in Children: Randomized Clinical Trial
Local anaesthesia is considered one of the most alarming and non-comfortable dental procedures for children. This goes back to the persisting effect of the local anaesthesia after finishing dental procedures. The effect of Local anaesthesia can last from 3 to 5 hours due to the presence of vasoconstrictor. The U.S Food and Drug Administration (FDA approved the use of phentolamine mesylate (Oraverse) in May 2008 to be used as a drug in reversing the numbing effect of Local anaesthesia by decreasing the time needed to restore the normal functions of the mouth
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | March 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 8 Years |
Eligibility | Inclusion Criteria: Children aged 6-8 years. - Patients in need of dental procedures requiring local anaesthesia. - Healthy Children without any systemic or mental disorders. - Normal lip sensation before administration of LA. - Normal paediatric functional assessment battery (pFAB) for smiling, speaking and drinking and absence of drooling. Exclusion Criteria: - Children seeking dental treatment that does not necessitate local anaesthesia. - Children who didn't achieve profound numbness requiring additional anaesthesia. - Children who lack the ability to distinct the anaesthetised numb side from the non-anaesthetised one. - Children who are not willing to participate in the study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to return to normal function | it is the time needed for the soft intraoral tisues e.g lips, tongue to return to their normal functions after local anaesthesia | 2 hours | |
Secondary | Incidence of self-inflicted soft tissue trauma | we observe clinical signs of redness, swelling, hematoma or ulcers due to lip biting at dismal of each participant | 2 hours | |
Secondary | Cost effectiveness of oraverse | we measure the cost effectiveness of the intervention drug through Incremental cost-effectiveness ratio (ICER) ICER=(C1-C0)/ (E1-E0) C1= cost of intervention drug C0= cost of control E1= effect of intervention drug E0= effect of control | Through the completion of the study, with average 1 year | |
Secondary | post-operative pain by 170 mm Heft-parker visual analogue scale (VAS) | it is 170mm scale from 0 to 170 mm and it represents
no pain: corresponds to 0 mm. mild pain: greater than 0 mm and less than or equal to 54 mm and included the description of faint and weak pain. moderate pain: greater than 54 mm and less than 114 mm. severe pain: equal to or greater than 114 mm to 170 mm and includes the description of strong and intense pain |
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