Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2025
INTERVENTION: This is a prospective, analytical, randomized, controlled, triple‐blind, crossover (split mouth) clinical trial where the patient is his/her own control. Experimental group: 21 patients who will undergo lower third molar surgery and will receive vitamin supplementation with 1 gram of ascorbic acid daily for a period of 7 days. Control group: patients who will undergo lower third molar surgery and who will use placebo tablets, similar to vitamin C, for a period of 7 days. The selected patients will be randomized into two intervention groups based on two draws. The draw will be made in two different envelopes: one containing 2 paper ballots with the words “right” and “left” to determine the first side of the patient to be operated on, and another envelope containing 2 papers labeled “A” or “B,” referring to the intervention, experimental or control groups, and consequently which medication would be used: vitamin C or placebo. To blind the participants to the scientific medications, the tablets will be compounded in a compound pharmacy by an assistant researcher. The tablets will be compounded in identical colors, shapes and sizes so that neither the operator nor the patient can differentiate the medications from the experimental group or the control group. From there, the tablets will be placed inside containers with colored labels (blue and red) corresponding to the medications (vitamin C or placebo). In this way, only the assistant researcher will know which medications will be administered in each surgery. In this way, neither the operator nor the patient nor the statistician who will evaluate the data will be aware of which medications will be used in each intervention CONDITION: A14.549.167.860.525.500 Ascorbic Acid, wound healing, pain,postoperative PRIMARY OUTCOME: The means of postoperative pain levels are expected to differ between the experimental and control groups. Pain intensity will be assessed using a visual analogue scale (10 centimeters), where zero represents no pain and 10 represents the maximum pain ever felt. The number of rescue pills taken by patients will be recorded after 7 days and will also be one of the parameters for assessing the pain outcome. INCLUSION CRITERIA: Healthy volunteers who do not continually use medications; both sexes; who are between 18 and 30 years old; that have teeth 38 and 48 in the same position; with indication for removal in an outpatient procedure under local anesthesia SECONDARY OUTCOME: A difference in the improvement of postoperative mouth opening is expected between patients in the control group and the experimental group. To measure the parameters of mandibular trismus, the maximum mouth opening (distance between the upper and lower left central incisor) will be taken using a properly calibrated digital caliper and measured with the results described in millimeters. A significant difference in postoperative healing is expected between the vitamin C group and the placebo group, on the 7th and 21st postoperative days. The Landry tissue repair index, the Löe and Silness gingival index, and the Early wound healing score will be used. Periodontal probing was also performed in the distovestibular and distolingual regions of the lower second molar, with subsequent comparison between the pre‐ and postoperative measurements. Periodontal probing was measured at three different times: preoperative, on the 7th postoperative day and on the 21st postoperative day
Epistemonikos ID: 7a057c3f256c92a90858ca17eeeb738159086fe6
First added on: May 26, 2025