Patients undergoing periodontal crown lengthening surgery. Gingivitis and periodontal diseases
Conditions
Interventions
Intervention 1: Intervention group:Participants receive a combination mouthwash containing Cetylpyridinium Chloride (CPC) and Tranexamic Acid (TXA) following periodontal surgery. The mouthwash is form
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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". | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra sadat Riazi nia
Mashhad University of Medical Sciences
Outcome results
None listed