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IRCT20200108046050N2 IRCT 2026-07-16 Tabriz University of Medical Sciences Effect of anti inflammatory diet on Patients with oral Lichen Planus Effect of anti inflammatory diet on clinical symptoms of Patients with oral Lichen Planus : Randomized clinical trial 2026-08-23 anticipated 60 Recruiting https://irct.ir/trial/91589 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be assigned to two intervention and control groups using a gender-stratified block randomization. Participants will first be divided into two groups: male and female. Then, within each group, they will be assigned to two groups using random blocks of variable size (4 and 6) and a ratio of 1:1. The randomization sequence will be generated by computer software. For allocation concealment, the method of sealed opaque envelopes which are numbered sequentially will be used. In this method, each random sequence is recorded on a card. Finally, the lids of the letter envelopes will be glued and placed inside a box. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed, Blinding description: The outcome assessor who will examine the patients will be blinded to the patient grouping and will record the clinical data in code form. 3 oral lichen planus. Intervention 1: Intervention group: Recipient of anti-inflammatory diet + routine treatment (Corticosteroid mouthwash). The intervention group will follow a standardized anti-inflammatory diet for 8 weeks. This diet is based on the principles of the Mediterranean-DASH modified diet and includes quantitative guidelines, a list of allowed/not allowed foods, and a weekly schedule. Participants must meet the following daily goals: 1. Fruits and vegetables at least: 5 units per day each unit = 80 g Minimum combination: three units of vegetables and 2 units of fruit 2. Whole grains at least: 3 units per day each unit: 1 slice of wholemeal bread (30 g) or ½ cup of rice 3. Chicken and fish and omega-3 at least: 2 servings per week (150–200 g per serving) 4. Oils Extra virgin olive oil: at least 2 tablespoons per day Prohibited: trans and industrial frying oils 5. Nuts and seeds 30 g per day (almonds, walnuts, hazelnuts) 6. Dairy 1–2 servings per day (preferably low-fat and without added sugar) Participants should minimize their intake of: Simple sugars <5% of daily calories, sugary drinks 0 to a maximum of 1 serving per week Fast food, maximum of 1 serving per month Processed meat, completely prohibited Red meat ≤ 1 serving per week (100–120 g) Fried foods, maximum of 1 serving per week Education and supportive intervention: In the initial education session, the principles of the anti-inflammatory diet will be taught and a list of allowed/not allowed foods will be given to patients in writing. A food portion size guide and a sample weekly meal plan will also be given to patients. To reduce implementation errors, a dietitian will be responsible for supervising patient education and monitoring their adherence. All recommendations will be standardized and uniform. Adherence to the intervention: A participant will be considered “adherent” when they meet at least 80% of the daily dietary goals. A phone call will be made every two weeks to monitor patient adherence. Intervention 2: Control group: Recipient of routine treatment (Corticosteroid mouthwash). Patients will use a full spoon of mouthwash containing 15 betamethasone ampules in Almg syrup every 8 hours. Yes - There is a plan to make this available What will be shared: The main outcomes of the study, including clinical scores and pain scores, in two groups and three time intervals will be published. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutes, doctors and dentists Conditions: Use of the data for further research or meta analysis is permitted. Where to obtain: Katayoun Katebi 00984133355965 Department of oral medicine, Tabriz faculty of dentistry katebik@tbzmed.ac.ir How to obtain: The applicant sends their request via email along with their introduction, and the information and data are sent to their email after reviewing their profile. Comments:
public Katayoun Katebi
Oral medicine department, faculty of Dentistry, Tabriz university of medical sciences, Golgasht street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 6955 katebik@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Katayoun Katebi
Oral medicine department, faculty of Dentistry, Tabriz university of medical sciences, Golgasht street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 6955 katebik@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of OLP based on clinical and histopathological criteria Age 18 to 65 years Presence of symptomatic erosive and ulcerative lesions Ability to adhere to diet Involvement of lesions in buccal mucosa, anterior two-thirds of tongue, labial mucosa, gingiva, and hard palate (where mouthwash can come into contact with them) Disease severity based on Thongprasom Score grade 4 and 3 18 years 65 years Both Taking immunosuppressive medications Having systemic diseases including diabetes, high blood pressure, cardiovascular and metabolic diseases, inflammatory bowel diseases Pregnancy or breastfeeding Consumption of alcohol or smoking On a vegetarian or other diet Presence of lesions in the pharynx, soft palate and back of the tongue that require systemic treatment due to lack of mouthwash contact L43 Lichen planus Rehabilitation Rehabilitation Intervention group: Recipient of anti-inflammatory diet + routine treatment (Corticosteroid mouthwash). The intervention group will follow a standardized anti-inflammatory diet for 8 weeks. This diet is based on the principles of the Mediterranean-DASH modified diet and includes quantitative guidelines, a list of allowed/not allowed foods, and a weekly schedule. Participants must meet the following daily goals: 1. Fruits and vegetables at least: 5 units per day each unit = 80 g Minimum combination: three units of vegetables and 2 units of fruit 2. Whole grains at least: 3 units per day each unit: 1 slice of wholemeal bread (30 g) or ½ cup of rice 3. Chicken and fish and omega-3 at least: 2 servings per week (150–200 g per serving) 4. Oils Extra virgin olive oil: at least 2 tablespoons per day Prohibited: trans and industrial frying oils 5. Nuts and seeds 30 g per day (almonds, walnuts, hazelnuts) 6. Dairy 1–2 servings per day (preferably low-fat and without added sugar) Participants should minimize their intake of: Simple sugars <5% of daily calories, sugary drinks 0 to a maximum of 1 serving per week Fast food, maximum of 1 serving per month Processed meat, completely prohibited Red meat ≤ 1 serving per week (100–120 g) Fried foods, maximum of 1 serving per week Education and supportive intervention: In the initial education session, the principles of the anti-inflammatory diet will be taught and a list of allowed/not allowed foods will be given to patients in writing. A food portion size guide and a sample weekly meal plan will also be given to patients. To reduce implementation errors, a dietitian will be responsible for supervising patient education and monitoring their adherence. All recommendations will be standardized and uniform. Adherence to the intervention: A participant will be considered “adherent” when they meet at least 80% of the daily dietary goals. A phone call will be made every two weeks to monitor patient adherence. Control group: Recipient of routine treatment (Corticosteroid mouthwash). Patients will use a full spoon of mouthwash containing 15 betamethasone ampules in Almg syrup every 8 hours. Clinical score based on Thongprasom scoring system. Timepoint: Clinical score measurement at the beginning of the study (before the intervention) and 4, 8 weeks after starting routine medication and anti-inflammatory diet. Method of measurement: The largest lesion in the oral cavity is selected and its largest diameter is recorded using a sterile surgical ruler. The scoring method is as follows: Score 0: No lesion. Score 1: White striae with erythematous area < 1 cm2. Score 2: White striae with erythematous area > 1 cm2. Score 3: White striae with erosive area < 1 cm2. Score 4: White striae with erosive area > 1 cm2. Pain level based on visual analogue scale. Timepoint: Pain level measurement at the beginning of the study (before the intervention) and 4, 8 weeks after starting routine medication and anti-inflammatory diet. Method of measurement: Patients will be asked to mark a 10 cm line with the left end representing no pain and the right end representing the most severe pain possible. Tabriz University of Medical Sciences Approved 2026-06-22 Ethics committee of Tabriz University of Medical Sciences Tabriz faculty of dentistry, Golghasht street Tabriz East Azarbaijan Iran (Islamic Republic of)