Oral Health CareTrypsinNCT07269171
The Effect of Supplementary Foods Containing Trypsin, Chymotrypsin and Serratia Peptidase on Healing After Impacted Wisdom Tooth Surgery
A study testing Pain Assessment, Number of Analgesics Needed and Edema Assessment in people with Oral Health Care, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health Care
- What is being tested?
- Pain Assessment, Number of Analgesics Needed and Edema Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a mandibular third molar with a unilateral or bilateral Class 2, Position A or B impaction according to the Pell and Gregory classification
- Being systemically healthy (ASA Class I)
- Aged between 18 and 45 years (young adult age group)
- Willingness to participate in the study
Who cannot join
- Age outside the specified range
- Pregnancy
- Currently breastfeeding
- Presence of infection in the third molar region (e.g., acute pericoronitis)
- Presence of cystic or tumoral lesions associated with the impacted third molar
- History of allergic reactions
Show all 10Show fewer
- Presence of any systemic disease
- Unwillingness to participate in the study
- Poor oral hygiene that may negatively affect healing
- Smoking or alcohol addiction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effects of Dietary Supplements Containing Trypsin, Chymotrypsin and Serratia Peptidase on Postoperative Edema, Pain and Trismus After Mandibular Impacted Third Molar Extraction.
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.
Read the detailed description
Impacted tooth extractions are the most common clinical procedure in oral and maxillofacial surgery. As with other oral surgical procedures, they are associated with a wide variety of complications, including swelling, pain, limited mouth opening (trismus), bleeding, nerve damage, and delayed healing (1-3). These complications develop following the inflammatory response to the surgical intervention and can be related to factors such as age, gender, systemic condition, position of the impacted tooth, poor oral hygiene, smoking, surgical experience, and duration of the procedure (3). However, the most common complications are pain, swelling, and limited mouth opening. These can lead to a decrease in quality of life, loss of work, and restrictions on social activities (4). To reduce the inflammation that occurs after impacted tooth extraction and to reduce the severity of the aforementioned complications, various medications can be used under the heading of pharmacological methods, or additional non-pharmacological methods such as modified surgical methods, drain placement, low-power laser applications, cold therapy, and physical therapy (5-8). Trypsin, chymotrypsin, and serratia peptidase are proteolytic enzymes and stand out for their various biological functions. The use of these enzymes after surgical interventions such as tooth extraction is being investigated to reduce complications such as postoperative edema, pain, and trismus during the healing process (9).
Proteolytic enzymes such as trypsin, chymotrypsin, and serratia peptidase, when used in conjunction with each other, may contribute to the reduction of postoperative edema, pain, and trismus. Each of these enzymes controls inflammation in different ways, can accelerate the healing process by degrading protein, and promotes faster tissue recovery after surgical trauma (10).
Trypsin is a protease produced by the pancreas and activated in the small intestine. Trypsin contributes to the digestive process by breaking down proteins into peptides and amino acids. Trypsin may help accelerate the healing process, particularly in the body, due to inflammation and tissue damage. This enzyme has effects such as reducing edema, wound healing, and controlling inflammation. It is frequently used after surgical interventions, such as tooth extractions, because it reduces postoperative edema and provides pain relief (11). Studies evaluating the effects of dietary supplements containing trypsin, chymotrypsin, and serratia peptidase after third molar surgery are available in the literature. The primary objective of this study was to clinically evaluate the effects of dietary supplements containing trypsin, chymotrypsin, and serratia peptidase on postoperative edema, pain, and trismus in the postoperative period of mandibular third molar extractions.
- Conditions
- Oral Health Care
- Being tested
- Pain Assessment, Number of Analgesics Needed, Edema Assessment, Trismus Assessment
- Keywords
- nutritional supplements, oral and maxillofacial surgery, wisdom teeth, trypsin, chymotrypsin and serratia peptidase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain AssessmentProcedure or surgery
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 NeededProcedure or surgery
In addition, the number of analgesics required by the patients up to the 7th postoperative day will be recorded.
Edema AssessmentProcedure or surgery
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 AssessmentProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients undergoing right mandibular third molar surgery will receive standard postoperative medication: painkillers (dexketoprofen 25 mg), antibiotics (amoxicillin 875 mg + clavulanic acid 125 mg), and a chlorhexidine 0.12% + benzydamine 0.15% mouthwash. Demographic data will be recorded preoperatively. All surgeries will be performed under sterile conditions with inferior alveolar nerve block and buccal infiltration using articaine 4% with epinephrine 1:100,000. Operation time will be measured from incision to last suture. Osteotomy and, when necessary, tooth sectioning will be performed with a surgical handpiece and saline irrigation. After extraction, sockets will be smoothed and closed with 3-0 silk sutures. Patients will be reviewed on postoperative days 1, 2, 3, and 7, and pain, edema, and trismus will be recorded. Receives: Procedure: Pain Assessment; Procedure: Number of Analgesics Needed; Procedure: Edema Assessment; Procedure: Trismus Assessment |
| Control group | Experimental | Patients undergoing right mandibular third molar surgery will receive standard postoperative medication, including dexketoprofen 25 mg, amoxicillin 875 mg + clavulanic acid 125 mg, and a 0.12% chlorhexidine + 0.15% benzydamine mouthwash. Demographic data will be recorded preoperatively. All operations will be performed under sterile conditions with inferior alveolar nerve block and buccal infiltration using 4% articaine with 1:100,000 epinephrine. Surgical time will be measured from incision to final suture. Osteotomy and, when required, tooth sectioning will be performed with a surgical handpiece and saline irrigation. After extraction, sockets will be smoothed and closed with 3-0 silk sutures. Patients will be evaluated on postoperative days 1, 2, 3, and 7 for pain, edema, and trismus. In addition, the control group will receive a dietary supplement containing trypsin, chymotrypsin, and serratiopeptidase (Tripser Forte N30, Incir Pharma, Türkiye), with identical follow-up. Receives: Procedure: Pain Assessment; Procedure: Number of Analgesics Needed; Procedure: Edema Assessment; Procedure: Trismus Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing status on 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)
Measured: Postoperative day 7
Change in pain levels after mandibular third molar surgery
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)
Measured: From postoperative day 1 to day 7
Change in burning sensation levels after mandibular third molar surgery
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)
Measured: From postoperative day 1 to day 7
Change in facial edema after mandibular third molar surgery
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.
Measured: Days 1,2,3 and 7
Change in trismus (maximum mouth opening) after mandibular third molar surgery
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.
Measured: Days 1,2,3 and 7
Secondary outcomes (1)
Number of analgesic tablets consumed postoperatively
Participants will record the number of analgesic tablets taken each day for 7 days after surgery in a home diary. The total number of tablets consumed will be calculated. Unit of Measure: Number of tablets per patient
Measured: From postoperative day 1 to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health CareStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgün Yıldırım, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269171
- Sponsor's protocol ID
- 15.05.2025-2025/9-9/11
- Acronym
- Trypsin
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient information will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Dietary Supplements Containing Trypsin, Chymotrypsin and Serratia Peptidase on Postoperative Edema, Pain and Trismus After Mandibular Impacted Third Molar Extraction.
- ClinicalTrials.gov ID
- NCT07269171
- Acronym / sponsor ID
- Trypsin / 15.05.2025-2025/9-9/11
- Conditions
- Oral Health Care
- Keywords
- nutritional supplements, oral and maxillofacial surgery, wisdom teeth, trypsin, chymotrypsin and serratia peptidase
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Impacted tooth extractions are the most common clinical procedure in oral and maxillofacial surgery. As with other oral surgical procedures, they are associated with a wide variety of complications, including swelling, pain, limited mouth opening (trismus), bleeding, nerve damage, and delayed healing (1-3). These complications develop following the inflammatory response to the surgical intervention and can be related to factors such as age, gender, systemic condition, position of the impacted tooth, poor oral hygiene, smoking, surgical experience, and duration of the procedure (3). However, the most common complications are pain, swelling, and limited mouth opening. These can lead to a decrease in quality of life, loss of work, and restrictions on social activities (4). To reduce the inflammation that occurs after impacted tooth extraction and to reduce the severity of the aforementioned complications, various medications can be used under the heading of pharmacological methods, or additional non-pharmacological methods such as modified surgical methods, drain placement, low-power laser applications, cold therapy, and physical therapy (5-8). Trypsin, chymotrypsin, and serratia peptidase are proteolytic enzymes and stand out for their various biological functions. The use of these enzymes after surgical interventions such as tooth extraction is being investigated to reduce complications such as postoperative edema, pain, and trismus during the healing process (9).
Proteolytic enzymes such as trypsin, chymotrypsin, and serratia peptidase, when used in conjunction with each other, may contribute to the reduction of postoperative edema, pain, and trismus. Each of these enzymes controls inflammation in different ways, can accelerate the healing process by degrading protein, and promotes faster tissue recovery after surgical trauma (10).
Trypsin is a protease produced by the pancreas and activated in the small intestine. Trypsin contributes to the digestive process by breaking down proteins into peptides and amino acids. Trypsin may help accelerate the healing process, particularly in the body, due to inflammation and tissue damage. This enzyme has effects such as reducing edema, wound healing, and controlling inflammation. It is frequently used after surgical interventions, such as tooth extractions, because it reduces postoperative edema and provides pain relief (11). Studies evaluating the effects of dietary supplements containing trypsin, chymotrypsin, and serratia peptidase after third molar surgery are available in the literature. The primary objective of this study was to clinically evaluate the effects of dietary supplements containing trypsin, chymotrypsin, and serratia peptidase on postoperative edema, pain, and trismus in the postoperative period of mandibular third molar extractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Pain Assessment, Procedure: Number of Analgesics Needed, Procedure: Edema Assessment, Procedure: Trismus AssessmentPatients undergoing right mandibular third molar surgery will receive standard postoperative medication: painkillers (dexketoprofen 25 mg), antibiotics (amoxicillin 875 mg + clavulanic acid 125 mg), and a chlorhexidine 0.12% + benzydamine 0.15% mouthwash. Demographic data will be recorded preoperatively. All surgeries will be performed under sterile conditions with inferior alveolar nerve block and buccal infiltration using articaine 4% with epinephrine 1:100,000. Operation time will be measured from incision to last suture. Osteotomy and, when necessary, tooth sectioning will be performed with a surgical handpiece and saline irrigation. After extraction, sockets will be smoothed and closed with 3-0 silk sutures. Patients will be reviewed on postoperative days 1, 2, 3, and 7, and pain, edema, and trismus will be recorded. |
| Control group | Experimental | Procedure: Pain Assessment, Procedure: Number of Analgesics Needed, Procedure: Edema Assessment, Procedure: Trismus AssessmentPatients undergoing right mandibular third molar surgery will receive standard postoperative medication, including dexketoprofen 25 mg, amoxicillin 875 mg + clavulanic acid 125 mg, and a 0.12% chlorhexidine + 0.15% benzydamine mouthwash. Demographic data will be recorded preoperatively. All operations will be performed under sterile conditions with inferior alveolar nerve block and buccal infiltration using 4% articaine with 1:100,000 epinephrine. Surgical time will be measured from incision to final suture. Osteotomy and, when required, tooth sectioning will be performed with a surgical handpiece and saline irrigation. After extraction, sockets will be smoothed and closed with 3-0 silk sutures. Patients will be evaluated on postoperative days 1, 2, 3, and 7 for pain, edema, and trismus. In addition, the control group will receive a dietary supplement containing trypsin, chymotrypsin, and serratiopeptidase (Tripser Forte N30, Incir Pharma, Türkiye), with identical follow-up. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having a mandibular third molar with a unilateral or bilateral Class 2, Position A or B impaction according to the Pell and Gregory classification
- Being systemically healthy (ASA Class I)
- Aged between 18 and 45 years (young adult age group)
- Willingness to participate in the study
Key exclusion criteria (10 listed)
- Age outside the specified range
- Pregnancy
- Currently breastfeeding
- Presence of infection in the third molar region (e.g., acute pericoronitis)
- Presence of cystic or tumoral lesions associated with the impacted third molar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain AssessmentPain 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. | Procedure or surgery | Control group, Study group |
| Number of Analgesics NeededIn addition, the number of analgesics required by the patients up to the 7th postoperative day will be recorded. | Procedure or surgery | Control group, Study group |
| Edema AssessmentTo 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. | Procedure or surgery | Control group, Study group |
| Trismus AssessmentTo 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. | Procedure or surgery | Control group, Study group |
Primary outcome
Wound healing status on postoperative day 7
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Number of analgesic tablets consumed postoperatively
Time frame: From postoperative day 1 to day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No. Patient information will be kept confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Assessment, Number of Analgesics Needed and Edema Assessment in people with Oral Health Care, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özgün YILDIRIM, Doctor, Assistant Professor (+905366687527, ozgunyldrm89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing status on postoperative day 7 (time frame: Postoperative day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.