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IRCT20250811066829N1 IRCT 2025-10-06 Tabriz University of Medical Sciences Comparison of the effect of coconut oil and pomegranate peel extract mouthwash on plaque-induced gingivitis with chlorhexidine mouthwash Comparison of the effect of coconut oil and pomegranate peel extract mouthwash on plaque-induced gingivitis with chlorhexidine mouthwash 2025-10-12 anticipated 40 Complete https://irct.ir/trial/85624 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Before using the desired mouthwash, the periodontal status of the volunteers is checked and these volunteers are randomly assigned to one of the intervention and control groups using a random number table so that the distribution of oral health and disease status is the same between the two groups. The method of randomization is done using a random number table. Random number tables are prepared by computers that randomly arrange the numbers. These tables have random numbers in both rows and columns, which usually add up to 99 rows and columns, and the numbers in the rows and columns are placed next to each other and separated in five-digit blocks to facilitate their use, Blinding description: Because the study is double-blind, except for the consultant supervisor as the third person in the study, none of the volunteers or students carrying out the project are aware of the placement of the study subject in the control or intervention group. In order to maintain confidentiality of the information for the individuals who were determined. The mouthwash container will be the same, Also, opaque containers will be used, so the contents of the containers will not be visible and no one other than the relevant professor will know how the mouthwash is distributed among the patients. 3 Patients with gingivitis. Intervention 1: Intervention group :The study group of 20 people will use 10ml of mouthwash containing coconut oil twice a day after waking up and before going to bed for 2 minutes. Intervention 2: Control group: The control group of 20 people will use CHX (chlorhexidine mouthwash) twice a day according to the manufacturer's instructions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Farshad Javadzadeh
Ground floor, Building of the Faculty of Dentistry,Tabriz University of Medical Sciences, Tabriz University, Golgasht Avenue, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 3298 Fa.javadzadeh@gmail.com Tabriz University of Medical Sciences scientific Farshad Javadzadeh
Ground floor, Building of the Faculty of Dentistry,Tabriz University of Medical Sciences, Tabriz University, Golgasht Avenue, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 3298 Fa.javadzadeh@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The age range of people is between 18 and 65 years old. Have clinical signs of gingivitis. Have plaque and calculus on tooth surfaces 18 years 65 years Both People with any systemic disease. Pregnant and breastfeeding mothers. People who used mouthwash. People who have had chemotherapy or are being treated with antibiotics. Patients with poor motivation and/or poor cooperation. Patients treated with calcium antagonists, cyclosporine, and phenytoin. Patients who are allergic to coconut. K05.10 Chronic gingivitis, plaque induced Treatment - Drugs Treatment - Drugs Intervention group :The study group of 20 people will use 10ml of mouthwash containing coconut oil twice a day after waking up and before going to bed for 2 minutes. Control group: The control group of 20 people will use CHX (chlorhexidine mouthwash) twice a day according to the manufacturer's instructions. Plaque Index: This refers to the presence or absence of plaque on the 6 surfaces of the teeth, which is measured on all teeth present in the patient's mouth. Timepoint: 14 days after using mouthwash. Method of measurement: The plaque index (DPI) is calculated using the O'Leary index (this index is useful for assessing the plaque control performance of patients and is relatively easy, reproducible and inexpensive to determine). For this purpose, the patient's mouth is first rinsed with plain water and the surfaces of his teeth are stained using a dye that is revealed to detect dental plaque. In the next step, the discoloration of the different surfaces of each tooth is examined. For this purpose, each stained surface will be examined for the accumulation of plaque-revealing tablets at the tooth-gingival junction and the stained areas will be recorded with a red mark on the form. Finally, the number of discolored surfaces is divided by the number of teeth multiplied by six (or the total number of stained surfaces) and expressed as a percentage. Gingival index :The gingival index (GI) is defined as a tool used to assess the severity of gingival inflammation based on the thickness and accumulation of plaque and debris, which helps evaluate patient adherence to oral hygiene practices. Timepoint: 14 days after using mouthwash. Method of measurement: The gingival index is recorded by the examiner using a Williams probe. The Löe & Silness method is used to assess the gingival index. The gingiva of each tooth is divided into four sections: mesiobuccal, distobuccal, midbuccal, and midlingual. Each section is scored from 0 to 3. If the gingiva appears normal and is not bleeding, a score of 0 is assigned; if there is little inflammation and no bleeding on probing, a score of 1; if there is moderate inflammation and bleeding on probing, a score of 2; and if there is severe inflammation and spontaneous bleeding, a score of 3. To obtain the gingival index of each tooth, the average gingival index of the surfaces of that tooth is calculated; and to obtain the gingival index of the entire mouth, the average gingival index of all teeth is calculated. BOP index: Bleeding on probing (BOP) is the primary parameter to set the threshold for gingivitis. Timepoint: 14 days after using mouthwash. Method of measurement: The Ainamo & Bay index will be used to measure the amount of bleeding from the gums (BOP). The probe is gently inserted into the gingival sulcus and after 10 seconds the presence or absence of bleeding is checked. Tabriz University of Medical Sciences Approved 2025-07-29 Ethics Committee of Tabriz University of Medical Sciences (Dentistry faculty) Azadi Street, Golgasht Street, Attarnishabori Street, Faculty of Medicine, Research Development and Coordination Center (RDCC) Tabriz East Azarbaijan Iran (Islamic Republic of)