Damaged Oral Mucosa
Conditions
Brief 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 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
Interventions
OTHERRepairing mouthwash
repairing mouthwash was used 3 times a day for 15 days after dental procedure
OTHERPlacebo mouthwash
placebo mouthwash was used 3 times a day for 15 days after dental procedure
Sponsors
Lacer S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy patients (ASA I and II), * both sexes, * over 18 years old * undergoing oral surgery (extractions, implants, etc.) * wish to participate in the study.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing evaluation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity evaluation | Pain was evaluated y subjects on a daily basis from procedure until day 7. | 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. |
Countries
Spain
Outcome results
None listed