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IRCT20260206068771N1 IRCT 2026-02-13 Mashhad University of Medical Sciences Comparison of the effects of a combined mouthwash of tranexamic acid and cetylpyridinium chloride in plaque reduction and bleeding control in patients undergoing crown lengthening surgery Comparison of the effects of a combined mouthwash of tranexamic acid and cetylpyridinium chloride in plaque reduction and bleeding control in patients undergoing crown lengthening surgery: A randomized, triple-blind clinical trial 2026-02-20 anticipated 86 Complete https://irct.ir/trial/89077 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block randomization Software used: Random Allocation Software Type of randomization: Block Allocation concealment method: Sealed opaque envelopes An independent colleague not involved in study assessments prepares the block randomization allocation list using Random Allocation Software with alternating block sizes of 4 and 6. Allocation concealment: Group codes (A and B) are placed in opaque, sequentially numbered, sealed envelopes. These envelopes are opened by someone other than the assessor after the patient's enrollment is finalized and just before the intervention begins, Blinding description: This study was designed as a triple-blind randomized clinical trial. Participants, the surgeon, the outcome assessor, and the statistical analyst were all blinded to group allocation. To implement blinding, the mouthwashes were packaged by an individual outside the research team who was not involved in treatment, outcome assessment, or data analysis. The mouthwashes were placed in identical bottles in terms of shape, color, volume, and labeling. Each bottle was identified only by a unique code, and the code list was kept with the individual responsible for randomization and was not disclosed until after the statistical analysis was completed. Participants received mouthwashes based on the assigned codes and were unaware of the type of solution they used. The surgeon and the clinical assessor recording outcome measures also had no access to group allocation. Data recording forms contained only participant codes. Data collection was performed by a trained assessor who was blinded to treatment allocation. Statistical analysis was conducted using coded data by an analyst who had no knowledge of group identities. 3 Patients undergoing periodontal crown lengthening surgery. Intervention 1: Intervention group:Participants receive a combination mouthwash containing Cetylpyridinium Chloride (CPC) and Tranexamic Acid (TXA) following periodontal surgery. The mouthwash is formulated by the Faculty of Pharmacy, Mashhad University of Medical Sciences. Patients are instructed to use 15 mL of the solution twice daily for 30 seconds, starting 24 hours after surgery, for a total duration of 7 days. The mouthwash is provided in identical coded bottles to maintain blinding. Intervention 2: Control group:Participants receive 0.12% chlorhexidine mouthwash following periodontal surgery. Patients are instructed to use 15 mL of the mouthwash twice daily for 30 seconds, starting 24 hours after surgery, for 7 days. The mouthwash is provided in identical coded bottles similar to the intervention group to maintain blinding. No - There is not a plan to make this available Justification or reason for not sharing IPD is اطلاعات بیشتری وجود ندارد
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Mashhad Iran (Islamic Republic of) 9187146461 +98 51 3623 4179 Floria.rzn@gmail.com Mashhad University of Medical Sciences scientific Zahra sadat Riazi nia
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Mashhad Iran (Islamic Republic of) 9187146461 +98 51 3623 4179 Floria.rzn@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Age 18–70 years Systemically healthy (ASA I–II) Requiring periodontal surgery following non-surgical treatment No use of antibiotics or antiseptic mouthwashes in the past 4 weeks No use of anticoagulants or medications affecting hemostasis in the past 10 days Normal coagulation status and platelet count· Acceptable oral hygiene following initial preparation Signed informed consent and ability to attend follow-up visits Smoking ≤10 cigarettes per day Controlled diabetes (HbA1c < 7%) Low plaque and bleeding scores in non-surgical areas No removable prostheses or active orthodontic appliances Acceptable oral hygiene following initial preparation 18 years 70 years Both ASA ≥ III or uncontrolled systemic disease Coagulation disorders or inability to adjust anticoagulant therapy Pregnancy or breastfeeding Allergy to mouthwash ingredients Active oral infection or uncontrolled abscess Severe, non-modifiable poor oral hygiene Use of medications that may affect outcomes (corticosteroids, immunosuppressants) Lack of legal capacity or competence to participate Non-adherence to mouthwash use or follow-up visits Heavy smoking (>20 cigarettes/day) Development of new oral disease or inflammatory lesions Intraoperative complications such as abnormal bleeding or vascular rupture Serious medical adverse events during the study K05 Gingivitis and periodontal diseases Treatment - Drugs Treatment - Drugs Intervention group:Participants receive a combination mouthwash containing Cetylpyridinium Chloride (CPC) and Tranexamic Acid (TXA) following periodontal surgery. The mouthwash is formulated by the Faculty of Pharmacy, Mashhad University of Medical Sciences. Patients are instructed to use 15 mL of the solution twice daily for 30 seconds, starting 24 hours after surgery, for a total duration of 7 days. The mouthwash is provided in identical coded bottles to maintain blinding. Control group:Participants receive 0.12% chlorhexidine mouthwash following periodontal surgery. Patients are instructed to use 15 mL of the mouthwash twice daily for 30 seconds, starting 24 hours after surgery, for 7 days. The mouthwash is provided in identical coded bottles similar to the intervention group to maintain blinding. Percentage of dental surfaces with plaque based on OLeary plaque control record following the use of mouthwash after periodontal surgery. Timepoint: Before intervention and seven days after initiation of mouthwash use following periodontal surgery. Method of measurement: Dental plaque is disclosed using a plaque disclosing agent and the percentage of tooth surfaces with plaque is calculated according to OLeary plaque control record by a calibrated examiner under standard clinical conditions. Presence or absence of bleeding after periodontal surgery. Bleeding is defined as either self-reported spontaneous bleeding in the past 7 days or observation of active bleeding or fresh blood clot at the surgical site during clinical examination. Timepoint: Before surgery and 1 week after periodontal surgery. Method of measurement: Patient self-report questionnaire + clinical examination. Qualitative recording (Yes/No). If at least one condition is met, bleeding is recorded as "Yes". Periodontal wound healing evaluated quantitatively using the Early Healing Index (EHI) ranging from 1 to 4 based on multiple clinical items. Timepoint: 1 week after periodontal surgery. Method of measurement: Visual and clinical examination by blinded examiner; scoring according to EHI criteria. Patient adherence to mouthwash regimen, calculated as percentage of actual use over 7 days. Timepoint: Daily recording for 7 days after surgery. Method of measurement: Patient self-reported questionnaire recording weekly and daily frequency of mouthwash use and duration of retention in the oral cavity.calculated as (actual doses taken / 7) × 100. Patient satisfaction. Timepoint: 1 week after periodontal surgery. Method of measurement: Patient satisfaction assessed by combined quantitative and qualitative measures: - Quantitative: Visual analogue scale from 0 (completely dissatisfied) to 10 (completely satisfied). - Qualitative: Standardized questionnaire evaluating behavioral-attitudinal aspects (willingness to repurchase, recommend, or continue use). Occurrence of any adverse events after intervention (Yes/No). Timepoint: 1 week after periodontal surgery. Method of measurement: Patient self-report questionnaire + clinical examination. Reporting as percentage of patients experiencing each adverse event. Mashhad University of Medical Sciences Approved 2025-11-29 Ethics Committee of Dentistry University of Mashhad Medical Sciences Dentistry University of medical Science, Beginning of the Vakilabad Boulevard, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)