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

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

Study Overview

• Status: Completed
• Conditions: Damaged Oral Mucosa
• Intervention / Treatment: Other: Repairing mouthwash; Other: Placebo mouthwash

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badajoz
    • Don Benito, Badajoz, Spain, 06400
      • Gala Servicios Clínicos, S.L.U.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repairing mouthwash; Repairing mouthwash was used 3 times a day during 15 days after the procedure	Other: Repairing mouthwash; repairing mouthwash was used 3 times a day for 15 days after dental procedure
Placebo Comparator: Placebo; Placebo was used 3 times a day during 15 days after the procedure	Other: Placebo mouthwash; placebo mouthwash was used 3 times a day for 15 days after dental procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The parameters were evaluated after the procedure and after 7 and 15 days of product use.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pain was evaluated y subjects on a daily basis from procedure until day 7.

Collaborators and Investigators

• Sponsor: Lacer S.A.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Nº23-003-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The results of the study will be shared in the publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No