Completed

NCT Number: NCT07385586

Evaluation of Mouthwash Use in Hygiene and Recovery After Interventions in Gums

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

Completed

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Key information

Conditions

Damaged Oral Mucosa

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gala Servicios Clínicos, S.L.U.

Don Benito, Badajoz, 06400, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Repairing mouthwash

Other

repairing mouthwash was used 3 times a day for 15 days after dental procedure

Placebo Mouthwash

Other

placebo mouthwash was used 3 times a day for 15 days after dental procedure

Primary outcomes

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.

Secondary outcomes

Pain intensity evaluation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lacer S.A.

Industry

Registry information

Official study 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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Feb 4, 2026
Registry last updated: Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.