Annex 1. Patient Information and Informed Consent for the Study. Study Title: Effectiveness of a Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash for the Treatment of Symptomatic Oral Lichen Planus. A Randomized Clinical Trial.
Principal Investigator: Dr. Rosa Mª López-Pintor Muñoz, Associate Professor, Department of Clinical Dental Specialties, Faculty of Dentistry, Complutense University of Madrid.
Dear Sir/Madam, We invite you to participate in a study to evaluate the effectiveness of a mouthwash to reduce the lesions and pain you experience due to oral lichen planus.
Study Objective The primary aim of this study is to evaluate and compare the effect of Tectum mouthwash (with sodium hyaluronate and Sh-Oligopeptide-85) versus a corticosteroid mouthwash treatment (which will be offered to you at no cost) in reducing pain and lesion size.
Since you have oral lichen planus and are experiencing discomfort, you will be given either Tectum mouthwash or a corticosteroid mouthwash to use after brushing your teeth for the first two weeks, three times a day, twice a day in the third week, and once a day in the final week of treatment.
You will be randomly assigned to receive either the Tectum mouthwash or the corticosteroid mouthwash, in a process similar to flipping a coin, and you will not know which treatment group you belong to. Neither you nor the attending clinician will know which treatment is being administered. You will need to use the assigned mouthwash for 4 weeks according to the clinician's instructions and visit the Faculty of Dentistry at 1, 2, 3, and 4 weeks to assess whether there has been any improvement.
On your first visit, a series of data will be recorded, and the lesions you have in your mouth due to oral lichen planus, as well as the pain you are experiencing, will be assessed. The same variables will be evaluated at 1, 2, 3, and 4 weeks to determine if the mouthwash is effective. You will also need to complete two questionnaires that assess the intensity of the pain you are experiencing and its impact on your quality of life. During the 4 weeks of treatment, you will not be allowed to use any other mouthwashes, nor can you use antibiotics or anti-inflammatory medications.
The new mouthwash is already marketed and has been used to treat conditions such as oral mucositis and xerostomia with good results, so we believe it may also be beneficial for oral lichen planus.
If you experience pain, you may take 400mg ibuprofen every 8 hours as needed. If you take it, you should record each dose and inform the healthcare professional who is attending you.
Voluntary Participation Your participation is entirely voluntary, and you are free to decide not to participate. You have the right to change your mind at any time, without explanation, and without any disadvantage to your treatment. Refusing to participate or withdrawing from this agreement will not affect your relationship with the institution in any way.
Study Procedures The dentist attending you in the Diploma of Specialization in Oral Medicine will invite you to participate in the study and provide you with detailed instructions. The attending dentist will ask you to complete a questionnaire with a series of questions necessary for the study. If you agree to participate, your lesions will be assessed, and you will fill out questionnaires.
Finally, the dentist will teach you how to use the product, which you will apply 3 times a day during the first and second weeks, 2 times a day during the third week, and once a day during the fourth week. After 1, 2, 3, and 4 weeks, you will return for follow-up appointments to evaluate the same variables and complete the questionnaires again.
Risks This study does not present any additional risks to you. It is possible that you may not notice any improvement with the use of the mouthwash. The response to corticosteroids and the new treatment may vary.
Confidentiality Your confidentiality will be maintained. All information collected during this research will be treated as privileged and documented in a coded format. You have the right to access and rectify your data at any time, as established by the Organic Law 3/2018, of December 5, on the Protection of Personal Data and Guarantee of Digital Rights. In accordance with the new data protection regulations, you may revoke the consent given and exercise your rights of access, modification, opposition, and deletion of data. You also have the right to limit the processing of incorrect data, request a copy of the data, or transfer it to a third party (portability) as applicable. To exercise your rights, you may contact the principal investigator of the study (Dr. Rosa Mª López-Pintor Muñoz, Department of Clinical Dental Specialties, Faculty of Dentistry, Complutense University of Madrid). You also have the right to contact the Data Protection Agency if you are not satisfied.
Your identity or any information that could identify you will not be disclosed