Damaged Oral MucosaNCT07385586
Evaluation of Mouthwash Use in Hygiene and Recovery After Interventions in Gums
A study testing Repairing mouthwash in people with Damaged Oral Mucosa, run by Lacer S.A. at 1 site in Spain.
Trial summary
The goal of this study was to learn if mouthwash works in aiding the healing of the gum tissue after trauma or dental procedure. The main questions it aims to answer are: Does mouthwash aid the healing of gum tissue? Does mouthwash help to reduce the pain? Is the mouthwash well accepted by the volunteers? Researchers… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Damaged Oral Mucosa
- What is being tested?
- Repairing mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2024to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients (ASA I and II),
- both sexes,
- over 18 years old
- undergoing oral surgery (extractions, implants, etc.)
- wish to participate in the study.
Who cannot join
- Patients undergoing healing with Platelet-Rich Plasma (PRP).
- Allergy or hypersensitivity to any of the product's components.
- Patients under psychiatric treatment.
- Pregnant or breastfeeding women.
- Treatment with NSAIDs, analgesics, or antibiotics for other conditions at the time of starting the study.
- Treatment with healing antiseptics or oral hygiene products for other oral problems.
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- Treatment with oral anticoagulants.
- Diabetics.
- Periodontal disease or an active infectious or acute inflammatory local process at the time of starting the study.
- Active smoking of more than 10 cigarettes per day.
- Poor oral hygiene.
- Any other condition deemed relevant by the specialist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Study for the Evaluation of the Efficacy of an Adjunct Mouthwash in Hygiene, Wound Healing, Analgesia, and Functional Recovery Following Trauma or Dental Procedures in Gingival Tissue
The goal of this study was to learn if mouthwash works in aiding the healing of the gum tissue after trauma or dental procedure. The main questions it aims to answer are:
- Does mouthwash aid the healing of gum tissue?
- Does mouthwash help to reduce the pain?
- Is the mouthwash well accepted by the volunteers? Researchers will compare mouthwash to a placebo (a look-alike substance that contains no active ingredient) to see if mouthwash works to improve gum tissue healing.
Participants will:
- Use mouthwash or a placebo every day for 15 days
- Visit the dental clinic once a week for evaluations
- Keep a diary of their symptoms
- Conditions
- Damaged Oral Mucosa
- Being tested
- Repairing mouthwash, Placebo mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repairing mouthwashOther
repairing mouthwash was used 3 times a day for 15 days after dental procedure
Placebo mouthwashOther
placebo mouthwash was used 3 times a day for 15 days after dental procedure
| Study group | Role | What they receive |
|---|---|---|
| Repairing mouthwash | Experimental | Repairing mouthwash was used 3 times a day during 15 days after the procedure Receives: Other: Repairing mouthwash |
| Placebo | Placebo comparator | Placebo was used 3 times a day during 15 days after the procedure Receives: Other: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing evaluation
Healing of the oral mucosa after the dental procedure was evaluated by the dentist on a 3 grade Likert scale (0 was good, 1 was acceptable, 2 was bad) taking into account wound edges, oral mucose colour and wound closure. The reduction of the score corresponded to improvement if the wound healing.
Measured: The parameters were evaluated after the procedure and after 7 and 15 days of product use.
Secondary outcomes (1)
Pain intensity evaluation
Pain was evaluated on a scale from 0 to 10, where 0 is no pain and 10 is the maximum pain. Reduction of the number corresponded to pain improvement.
Measured: Pain was evaluated y subjects on a daily basis from procedure until day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2024
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Damaged Oral MucosaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lacer S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385586
- Sponsor's protocol ID
- Nº23-003-1
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of the study will be shared in the publication.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Study for the Evaluation of the Efficacy of an Adjunct Mouthwash in Hygiene, Wound Healing, Analgesia, and Functional Recovery Following Trauma or Dental Procedures in Gingival Tissue
- ClinicalTrials.gov ID
- NCT07385586
- Acronym / sponsor ID
- Nº23-003-1
- Conditions
- Damaged Oral Mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lacer S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 4 Feb 2026 (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.
The goal of this study was to learn if mouthwash works in aiding the healing of the gum tissue after trauma or dental procedure. The main questions it aims to answer are:
- Does mouthwash aid the healing of gum tissue?
- Does mouthwash help to reduce the pain?
- Is the mouthwash well accepted by the volunteers? Researchers will compare mouthwash to a placebo (a look-alike substance that contains no active ingredient) to see if mouthwash works to improve gum tissue healing.
Participants will:
- Use mouthwash or a placebo every day for 15 days
- Visit the dental clinic once a week for evaluations
- Keep a diary of their symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repairing mouthwash | Experimental | Other: Repairing mouthwashRepairing mouthwash was used 3 times a day during 15 days after the procedure |
| Placebo | Placebo comparator | Other: Placebo mouthwashPlacebo was used 3 times a day during 15 days after the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy patients (ASA I and II),
- both sexes,
- over 18 years old
- undergoing oral surgery (extractions, implants, etc.)
- wish to participate in the study.
Key exclusion criteria (12 listed)
- Patients undergoing healing with Platelet-Rich Plasma (PRP).
- Allergy or hypersensitivity to any of the product's components.
- Patients under psychiatric treatment.
- Pregnant or breastfeeding women.
- Treatment with NSAIDs, analgesics, or antibiotics for other conditions at the time of starting the study.
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 |
|---|---|---|
| Repairing mouthwashrepairing mouthwash was used 3 times a day for 15 days after dental procedure | Other | Repairing mouthwash |
| Placebo mouthwashplacebo mouthwash was used 3 times a day for 15 days after dental procedure | Other | Placebo |
Primary outcome
Healing evaluation
Time frame: The parameters were evaluated after the procedure and after 7 and 15 days of product use.
Healing of the oral mucosa after the dental procedure was evaluated by the dentist on a 3 grade Likert scale (0 was good, 1 was acceptable, 2 was bad) taking into account wound edges, oral mucose colour and wound closure. The reduction of the score corresponded to improvement if the wound healing.
1 secondary outcome
Pain intensity evaluation
Time frame: Pain was evaluated y subjects on a daily basis from procedure until day 7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. The results of the study will be shared in the publication.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repairing mouthwash in people with Damaged Oral Mucosa, run by Lacer S.A. 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 4 Feb 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing evaluation (time frame: The parameters were evaluated after the procedure and after 7 and 15 days of product use.). 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 4 Feb 2026.