Oral Lichen PlanusPhase 4NCT07280442
Effectiveness of a Sodium Hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash for the Treatment of Symptomatic Oral Lichen Planus
A Phase 4 study testing Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash in people with Oral Lichen Planus, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2026to 15 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant or breastfeeding women.
- Allergy to the components of the Tectum-11® mouthwash.
- Patients receiving corticosteroids, immunosuppressants, hydroxychloroquine, or retinoids at the time of recruitment.
- Patients with lichenoid lesions: drug-induced lichenoid reactions, contact lichenoid lesions, or graft-versus-host disease.
- Use of topical corticosteroids within the previous 4 weeks or systemic treatment within the previous 8 weeks.
- Use of other mouthrinses for plaque control.
Show all 14Show fewer
- Patients unwilling to sign the informed consent form.
- Patients with a VAS score > 6.
- The presence of any of the following criteria will lead to withdrawal of the participant from the study:
- Failure to attend follow-up visits.
- Occurrence of adverse events deemed clinically relevant by the investigator.
- The patient reports that they no longer wish to participate in the study.
- Development of oral or systemic lesions that meet any of the exclusion criteria.
- Non-adherence to the treatment regimen, defined as failure to follow the protocol for more than two consecutive weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Departamento de Especialidades Clínicas Odonotlógicas, Facultad de Odontología, Universidad Complutense de Madrid
Madrid, 28040
ROSA MARIA LÓPEZ-PINTOR FULL PROFESSOR
About this study
Official 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
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.
Read more
Dear Sir/Madam, Participants are invited to take part in a study evaluating the effectiveness of a mouthwash designed to reduce oral lichen planus-related lesions and pain.
Study Objective The primary aim of this study is to evaluate and compare the effect of Tectum mouthwash (containing sodium hyaluronate and Sh-Oligopeptide-85) versus a corticosteroid mouthwash (provided at no cost to participants) in reducing pain and lesion size.
Eligible participants with oral lichen planus and associated discomfort will receive either Tectum mouthwash or a corticosteroid mouthwash to use after toothbrushing for the first two weeks three times daily, twice daily in the third week, and once daily in the fourth week of treatment.
Participants will be randomly assigned to receive either Tectum mouthwash or the corticosteroid mouthwash through a process comparable to a coin toss. Treatment allocation will be blinded. Neither participants nor the attending clinician will know which treatment is being administered. Participants must use the assigned mouthwash for 4 weeks according to the clinician's instructions and attend visits at the Faculty of Dentistry at 1, 2, 3, and 4 weeks to assess improvement.
At the first visit, a series of data will be recorded, and oral lichen planus lesions and pain will be assessed. The same variables will be evaluated at 1, 2, 3, and 4 weeks to determine treatment effectiveness. Participants will also complete two questionnaires assessing pain intensity and the impact of symptoms on quality of life. During the 4-week treatment period, the use of any other mouthwashes will not be permitted, and antibiotics or anti-inflammatory medications may not be used.
The investigational mouthwash is already marketed and has been used to treat conditions such as oral mucositis and xerostomia with favorable results; therefore, potential benefit in oral lichen planus is anticipated.
If pain occurs, 400 mg ibuprofen may be taken every 8 hours as needed. If ibuprofen is taken, each dose should be recorded and reported to the attending healthcare professional.
Voluntary Participation Participation is entirely voluntary, and non-participation is permitted. Participants may withdraw at any time without providing an explanation and without any disadvantage to clinical care. Refusal to participate or withdrawal will not affect the relationship between participants and the institution.
Study Procedures The dentist providing care in the Diploma of Specialization in Oral Medicine will invite eligible individuals to participate and will provide detailed instructions. The attending dentist will request completion of a questionnaire containing study-required information. If participation is accepted, lesions will be assessed, and questionnaires will be completed.
The attending dentist will instruct participants on product use: three times daily during weeks 1 and 2, twice daily during week 3, and once daily during week 4. Follow-up appointments at 1, 2, 3, and 4 weeks will be scheduled to evaluate the same variables and to repeat the questionnaires.
Risks This study does not present additional risks beyond routine care. Improvement may not occur with use of the mouthwash. Response to corticosteroids and to the investigational treatment may vary.
Confidentiality Confidentiality will be maintained. All information collected during this research will be treated as privileged and documented in coded format. Participants have the right to access and rectify personal data at any time, as established by Organic Law 3/2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights. In accordance with data protection regulations, consent may be revoked and rights of access, modification, opposition, and deletion of data may be exercised. Rights to limit the processing of inaccurate data, request a copy of the data, or request transfer of data to a third party (portability), as applicable, may also be exercised.
To exercise these rights, contact may be made with the principal investigator (Dr. Rosa Mª López-Pintor Muñoz, Department of Clinical Dental Specialties, Faculty of Dentistry, Complutense University of Madrid). Participants may also contact the Spanish Data Protection Agency if concerns are not resolved satisfactorily.
Participant identity and any information that could identify a participant will not be disclosed.
- Conditions
- Oral Lichen Planus
- Being tested
- Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash, Placebo
- Keywords
- oral lichen planus, RCT, OPMD, treatment, topical treatment, Sh-Oligopeptide-85 SP Mouthwash, Sodium hyaluronate 0.01%
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP MouthwashCombination product
Patients in the study group will be instructed to use 20 mL of Tectum-11® mouthwash after toothbrushing three times a day for 2 minutes. This procedure will be repeated daily throughout the 4-week treatment period. Patients will be asked not to eat or drink for 30 minutes after using the mouthwash.
PlaceboOther
Patients in the placebo group will use 20 mL of the placebo mouthwash after toothbrushing three times a day for 2 minutes. This procedure will be repeated daily throughout the 4-week treatment period. Patients will be asked not to eat or drink for 30 minutes after using the mouthwash.
| Study group | Role | What they receive |
|---|---|---|
| Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash | Experimental | Patients in the study group will be instructed to use 20 mL of Tectum-11® mouthwash after toothbrushing three times a day for 2 minutes. This procedure will be repeated daily throughout the 4-week treatment period. Patients will be asked not to eat or drink for 30 minutes after using the mouthwash. Receives: Combination Product: Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash |
| placebo mouthwash | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
pain form 0 to 10 (0: no pain; 10: worst pain imaginable)
Measured: at baseline, 7days, 14days, 21 days, 28days
Secondary outcomes (2)
Reticular Erosive Ulcerative score (REU), (from 0 to 115). The higher the score, the greater the severity
To assess the appearance and severity of the lesions, the REU scoring system, validated for OLP, will be used. This grading system assigns a site-specific score according to the type of lesion present (reticular, erosive, or ulcerative), which are weighted in a final formula to determine a single overall lesion score for each patient. The anatomical sites are: upper and lower labial mucosa, right buccal mucosa, left buccal mucosa, soft palate, hard palate, floor of the mouth, dorsal tongue, ventral tongue, maxillary gingiva, and mandibular gingiva. The site-specific scoring will be as follows:
Reticular or hyperkeratotic lesions:
0: No white lesions
1: Presence of striated lesions or hyperkeratotic papules
Erythematous or erosive lesions:
0: No lesion
- Lesion <1 cm²
- Lesion 1-3 cm²
- Lesion >3 cm²
Ulcerative lesions:
0: No lesion
- Lesion <1 cm²
- Lesion 1-3 cm²
- Lesion >3 cm² The total score across the 10 sites will be calculated using the followi
Measured: baseline, 7days, 14days, 21days, 28days
Oral Health Impact Profile 14 (OHIP-14) From 0 to 56. The higher the OHIP-14 score, the worse the oral health-related quality of life
To assess the impact of OLP on the patient's oral health-related quality of life, the Oral Health Impact Profile (OHIP-14) will be used. This instrument evaluates seven dimensions:
Functional limitation Physical pain Psychological discomfort Physical disability Psychological disability Social disability Handicap
The OHIP-14 comprises 14 items, each scored on a 5-point Likert scale:
0 = Never
- = Hardly ever
- = Occasionally
- = Fairly often
- = Very often
Measured: baseline, 76days, 14days,21days,28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start8 Jan 2026 (estimated)
- Primary completion17 Dec 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280442
- Sponsor's protocol ID
- 25/288-E
- Status last verified
- May 2025
- First submitted
- 1 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07280442
- Acronym / sponsor ID
- 25/288-E
- Conditions
- Oral Lichen Planus
- Keywords
- oral lichen planus, RCT, OPMD, treatment, topical treatment, Sh-Oligopeptide-85 SP Mouthwash, Sodium hyaluronate 0.01%
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 8 Jan 2026 (estimated)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, Participants are invited to take part in a study evaluating the effectiveness of a mouthwash designed to reduce oral lichen planus-related lesions and pain.
Study Objective The primary aim of this study is to evaluate and compare the effect of Tectum mouthwash (containing sodium hyaluronate and Sh-Oligopeptide-85) versus a corticosteroid mouthwash (provided at no cost to participants) in reducing pain and lesion size.
Eligible participants with oral lichen planus and associated discomfort will receive either Tectum mouthwash or a corticosteroid mouthwash to use after toothbrushing for the first two weeks three times daily, twice daily in the third week, and once daily in the fourth week of treatment.
Participants will be randomly assigned to receive either Tectum mouthwash or the corticosteroid mouthwash through a process comparable to a coin toss. Treatment allocation will be blinded. Neither participants nor the attending clinician will know which treatment is being administered. Participants must use the assigned mouthwash for 4 weeks according to the clinician's instructions and attend visits at the Faculty of Dentistry at 1, 2, 3, and 4 weeks to assess improvement.
At the first visit, a series of data will be recorded, and oral lichen planus lesions and pain will be assessed. The same variables will be evaluated at 1, 2, 3, and 4 weeks to determine treatment effectiveness. Participants will also complete two questionnaires assessing pain intensity and the impact of symptoms on quality of life. During the 4-week treatment period, the use of any other mouthwashes will not be permitted, and antibiotics or anti-inflammatory medications may not be used.
The investigational mouthwash is already marketed and has been used to treat conditions such as oral mucositis and xerostomia with favorable results; therefore, potential benefit in oral lichen planus is anticipated.
If pain occurs, 400 mg ibuprofen may be taken every 8 hours as needed. If ibuprofen is taken, each dose should be recorded and reported to the attending healthcare professional.
Voluntary Participation Participation is entirely voluntary, and non-participation is permitted. Participants may withdraw at any time without providing an explanation and without any disadvantage to clinical care. Refusal to participate or withdrawal will not affect the relationship between participants and the institution.
Study Procedures The dentist providing care in the Diploma of Specialization in Oral Medicine will invite eligible individuals to participate and will provide detailed instructions. The attending dentist will request completion of a questionnaire containing study-required information. If participation is accepted, lesions will be assessed, and questionnaires will be completed.
The attending dentist will instruct participants on product use: three times daily during weeks 1 and 2, twice daily during week 3, and once daily during week 4. Follow-up appointments at 1, 2, 3, and 4 weeks will be scheduled to evaluate the same variables and to repeat the questionnaires.
Risks This study does not present additional risks beyond routine care. Improvement may not occur with use of the mouthwash. Response to corticosteroids and to the investigational treatment may vary.
Confidentiality Confidentiality will be maintained. All information collected during this research will be treated as privileged and documented in coded format. Participants have the right to access and rectify personal data at any time, as established by Organic Law 3/2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights. In accordance with data protection regulations, consent may be revoked and rights of access, modification, opposition, and deletion of data may be exercised. Rights to limit the processing of inaccurate data, request a copy of the data, or request transfer of data to a third party (portability), as applicable, may also be exercised.
To exercise these rights, contact may be made with the principal investigator (Dr. Rosa Mª López-Pintor Muñoz, Department of Clinical Dental Specialties, Faculty of Dentistry, Complutense University of Madrid). Participants may also contact the Spanish Data Protection Agency if concerns are not resolved satisfactorily.
Participant identity and any information that could identify a participant will not be disclosed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash | Experimental | Combination Product: Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP MouthwashPatients in the study group will be instructed to use 20 mL of Tectum-11® mouthwash after toothbrushing three times a day for 2 minutes. This procedure will be repeated daily throughout the 4-week treatment period. Patients will be asked not to eat or drink for 30 minutes after using the mouthwash. |
| placebo mouthwash | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding women.
- Allergy to the components of the Tectum-11® mouthwash.
- Patients receiving corticosteroids, immunosuppressants, hydroxychloroquine, or retinoids at the time of recruitment.
- Patients with lichenoid lesions: drug-induced lichenoid reactions, contact lichenoid lesions, or graft-versus-host disease.
- Use of topical corticosteroids within the previous 4 weeks or systemic treatment within the previous 8 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP MouthwashPatients in the study group will be instructed to use 20 mL of Tectum-11® mouthwash after toothbrushing three times a day for 2 minutes. This procedure will be repeated daily throughout the 4-week treatment period. Patients will be asked not to eat or drink for 30 minutes after using the mouthwash. | Combination product | Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash |
| PlaceboPatients in the placebo group will use 20 mL of the placebo mouthwash after toothbrushing three times a day for 2 minutes. This procedure will be repeated daily throughout the 4-week treatment period. Patients will be asked not to eat or drink for 30 minutes after using the mouthwash. | Other | placebo mouthwash |
Primary outcome
Visual Analog Scale (VAS)
Time frame: at baseline, 7days, 14days, 21 days, 28days
pain form 0 to 10 (0: no pain; 10: worst pain imaginable)
2 secondary outcomes
Reticular Erosive Ulcerative score (REU), (from 0 to 115). The higher the score, the greater the severity
Time frame: baseline, 7days, 14days, 21days, 28days
Oral Health Impact Profile 14 (OHIP-14) From 0 to 56. The higher the OHIP-14 score, the worse the oral health-related quality of life
Time frame: baseline, 76days, 14days,21days,28days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash in people with Oral Lichen Planus, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ROSA MARÍA LÓPEZ-PINTOR FULL PROFESSOR (+34 ext. 91 394 1964, rmlopezp@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: at baseline, 7days, 14days, 21 days, 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.