An interventional study of Arnica montana and Placebo in Edema, Pain and Trismus, sponsored by Saint-Joseph University. Completed at 1 site in Lebanon. Open to participants aged 16 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Saint-Joseph University · Not applicable, Interventional, and Treatment
Aim: The aim of this study is to evaluate the action of the homeopathic plant Arnica Montana on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth.
Materials and Methods: The study is a double-blinded clinical trial recruiting patients undergoing surgical extraction of symmetrically impacted maxillary or mandibular third molars (right and left side). Patients receive alternately and randomly the verum (Arnica Montana 12 CH) or the placebo, in the form of capsules, to be taken 1 day prior to surgery and for 7 days postoperatively. Clinical parameters are collected and include: pain score, maximum mouth opening and facial measurements to assess edema's intensity.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's enrollment of 10 is below the median of 52 across 401 interventional studies indexed under Edema.
Browse Edema studies →Saint-Joseph University is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Patients will take Arnica montana before and after surgery
Drug: Arnica montana
Patients will take placebo pills to compare the results
Other: Placebo
Assess the effect of arnica montana on pain, swelling ans trismus after impacted third molar surgery
Patients will take placebo drug after surgeries
Pain VSA
Assessment of pain on visual analogue scale (between 0 and 10, 0 being no pain at all and 10 being the worst pain)
Time frame: at 0,1,2,3,4,5,6,7 days after surgery
Amount of face Swelling
Assessment of swelling after the intervention using a flexible ruler to measure the distance between fixed fixed reference points marked on the face: * G: Mandibular angle * C: External canthus * T: Tragus * S: Sub-nasal point * P: Pogonion
Time frame: at 0,2,7 days after surgery
Trismus intensity
Assessment of limitation of mouth opening after intervention between the incisal edges of the maxillary and the mandibular central incisors using a vernier caliper
Time frame: at 0,2 and 7 days after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Aug 2023, 18 months.
Of 153 non-industry interventional studies with no phase under Edema, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 18 months is above that.
Counting every sponsor, half of 168 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Arnicae flos extract
Saint-Joseph University