The Effect of Supplementary Foods Containing Trypsin, Chymotrypsin and Serratia Peptidase on Healing After Impacted Wisdom Tooth Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Pain Assessment: Pain will be assessed using a VAS on the 1st, 2nd, 3rd, and 7th postoperative days. For this purpose, the patient will be shown a 100-mm line with "0" at the left end and "100" at the right end. They will be instructed to mark the point on this line where their pain corresponds. The distance from the marked point to "0" will be measured with a ruler, and the resulting value will be recorded in mm to obtain the VAS score. Changes in these measurements will be recorded.

Number of Analgesics Needed: In addition, the number of analgesics required by the patients up to the 7th postoperative day will be recorded.

Edema Assessment: To assess edema, the tragus, lateral cauntus, corner of the mouth, and soft tissue pogonion points on the patient's face were marked preoperatively. Preoperatively, on the first, second, third, and seventh postoperative day, measurements will be taken and recorded between the Gonion-corner of the mouth, the Tragus-corner of the mouth, and the Gonion-lateral cauntus points.

Trismus Assessment: To assess trismus, the distance between the incisal edges of the upper and lower incisors will be measured and recorded with the mouth maximally open, preoperatively, and on the first, second, third, and seventh postoperative day.

Study summary

Introduction: The aim of this study was to determine the effects of a dietary supplement containing trypsin, chymotrypsin, and serratia peptidase (Tripser Forte N30, Incir Pharma, Turkey) on postoperative healing and to determine the differences between the groups. The aim was to identify differences between the groups regarding postoperative pain, edema, and trismus levels.

Material and Method: Demographic data before surgery will be recorded on the patient follow-up form (Appendix 1). All surgical procedures will be performed under sterile conditions following the administration of local anesthesia (80 mg articaine hydrochloride and 0.02 mg epinephrine, Maxicaine Fort ampoule, Vem Pharmaceuticals, Istanbul, Turkey) with inferior alveolar block anesthesia and buccal mucosa anesthesia. Procedure monitoring will begin after the incision is made and will conclude with suturing. Osteotomy (bone removal) and, if necessary, root dissection will be performed using a surgical handpiece, accompanied by irrigation with sterile saline solution. Following tooth extraction, the socket will be examined, and any sharp bony prominences will be removed. The area will be closed primarily using non-resorbable silk suture material (3/0 surgical silk suture, Doğsan, Turkey). A sterile tampon will be applied to the procedure area, and the patient will be instructed to bite on the tampon for 20 minutes before removing it and replacing it with another material. As a standard postoperative approach, all patients in group 1 received antibiotics (875 mg Amoxicillin+125 mg clavulonic acid, Augmentin-BID film coated tablets, GlaxoSmithKline, Istanbul, Turkey), analgesics (25 mg dexketoprofen, Arveles tb, UFSA Pharmaceutical Industry and Trade Inc. Davutpasa Cad. No.12 (34473) Topkapi/Istanbul) and mouthwash (100 ml solution containing 120 mg (%0.12) chlorhexidine gluconate and 150 mg (%0.15) benzydamine hydrochloride) for use after surgery. Drogsan Pharmaceutical Industry and Trade Inc. Oguzlar neighborhood, 1370.sokak 7/3 Balgat 06520 Cankaya/Ankara). Patients will be instructed to take antibiotics morning and evening for 5 days, use mouthwash for 7 days starting the day after the procedure, and use mouthwash only when deemed necessary. They will be asked to record the amount they use on the provided home assessment form (Appendix 2). Patients in Group 2 will be given a dietary supplement containing trypsin, chymotrypsin, and serratia peptidase (Tripser Forte N30, Incir Pharma, Turkey) in addition to the medications mentioned above. Patient follow-up procedures will be the same.

All patients will be evaluated on the 1st, 2nd, 3rd, and 7th postoperative days, and pain, edema, and trismus will be recorded.

Eligibility

Primary outcome measure(s)

• Wound healing status on postoperative day 7 — Postoperative day 7
  The surgical site will be clinically evaluated for wound healing on day 7 after surgery using a standardized Early Wound Healing Index (EHI), which assesses clinical signs such as redness, swelling, bleeding, and epithelialization. The EHI is scored on a scale from 0 to 5, where 0 indicates very poor healing and 5 indicates excellent healing. Higher scores reflect better healing outcomes. Unit of Measure: Early Wound Healing Index score (0-5)
• Change in pain levels after mandibular third molar surgery — From postoperative day 1 to day 7
  Pain levels will be assessed daily for 7 days following mandibular third molar surgery using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Patients will complete the VAS form daily, and the average score across the 7-day period will be calculated for each participant. Unit of Measure: Visual Analog Scale score (0-10)
• Change in burning sensation levels after mandibular third molar surgery — From postoperative day 1 to day 7
  Burning sensation levels will be assessed daily for 7 days following mandibular third molar surgery using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Patients will complete the VAS form daily, and the average score across the 7-day period will be calculated for each participant. Unit of Measure: Visual Analog Scale score (0-10)
• Change in facial edema after mandibular third molar surgery — Days 1,2,3 and 7
  Facial edema will be assessed on postoperative days 1, 2, 3, and 7 following mandibular third molar surgery. Swelling will be measured using standardized linear facial measurements obtained with a flexible tape measure between fixed anatomical points (e.g., tragus-oral commissure, tragus-pogonion, and lateral canthus-gonion). The sum of these distances will be recorded at each visit, and the change in facial measurement values over time will be used to evaluate edema. Higher values indicate greater facial swelling.
• Change in trismus (maximum mouth opening) after mandibular third molar surgery — Days 1,2,3 and 7
  Trismus will be evaluated on postoperative days 1, 2, 3, and 7 by measuring maximum mouth opening using a calibrated ruler or caliper. Maximum interincisal distance (between the incisal edges of the upper and lower central incisors) will be recorded at each time point. The change in maximum mouth opening over time will be used to assess trismus. Lower interincisal distance values indicate greater trismus.

Trial sites (1)

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