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

NCT07385586 | Completed

• 1 other identifier: Nº23-003-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Damaged Oral Mucosa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain intensity evaluation

  Pain was evaluated y subjects on a daily basis from procedure until day 7.

Study Arms (2)

Repairing mouthwash

EXPERIMENTAL

Repairing mouthwash was used 3 times a day during 15 days after the procedure

Other: Repairing mouthwash

Placebo

PLACEBO COMPARATOR

Placebo was used 3 times a day during 15 days after the procedure

Other: Placebo mouthwash

Interventions

Repairing mouthwash OTHER

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

Repairing mouthwash

Placebo mouthwash OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patients (ASA I and II),
• both sexes,
• over 18 years old
• undergoing oral surgery (extractions, implants, etc.)
• wish to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lacer S.A.: lead

Study Sites (1)

Gala Servicios Clínicos, S.L.U.

Don Benito, Badajoz, 06400, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2024
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)