Post-Extraction Healing: microRepair vs Chlorhexidine

April 23, 2026 updated by: Fabrizio Guerra, University of Roma La Sapienza

Evaluation of Healing in Post-Extraction Sockets Using microRepair Abx Mousse Mouthwash Versus 0.20% Chlorhexidine

This randomized clinical trial evaluates the efficacy of a microRepair ABX mouthwash mousse compared to 0.20% chlorhexidine in promoting wound healing following tooth extraction. The study monitors clinical parameters such as pain, swelling, and healing indices at 1, 7, and 15 days post-surgery. The primary objective is to determine if the microRepair ABX technology enhances tissue regeneration and reduces post-operative complications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study aims to prospectively analyze the clinical action of two different topical agents on post-surgical wounds: a mousse containing biomimetic microparticles (microRepair ABX) and a standard 0.20% chlorhexidine liquid mouthwash. Patients scheduled for extraction due to endodontic or periodontal issues will be randomized into two treatment groups. The protocol includes a baseline assessment (T0) and subsequent clinical evaluations at 24 hours (T1), 7 days (T2), and 15 days (T3). Primary endpoints consist of plaque presence on the surgical wound, gingival texture, and pain levels measured via the Visual Analogue Scale (VAS). Secondary endpoints include swelling (edema), odor, tooth or prosthesis pigmentation, and oral health-related quality of life (OHIP-14). Wound healing progress is objectively quantified using the Clinical Healing Index (CHI), which assesses seven parameters: redness, edema, bleeding, pain on palpation, suppuration, granulation tissue, and the degree of epithelialization. Additionally, the study evaluates patient satisfaction and the "pleasantness" of the assigned product, while recording any adverse events or sensitivities during home application.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age range: Patients between 18 and 75 years of age.

Indication for tooth extraction: Specifically for cases involving:

  • Destructive caries that do not allow for conservative or prosthetic recovery.
  • Untreatable endodontic and/or periapical lesions.
  • Advanced periodontal lesions with significant loss of supporting tissue.
  • Traumatic lesions involving root fractures (vertical or at the middle third).
  • Malpositioned teeth causing functional alterations.
  • Roots that cannot be prosthetically recovered or residual roots.

Exclusion Criteria:

Age: Patients under 18 or over 75 years of age. Systemic Conditions: Presence of immunodepression or immunocompromisation (e.g., HIV infection).

Pregnancy and Lactation: Women who are currently pregnant or breastfeeding. Mental Health: Presence of psychiatric disorders. Tobacco Use: Severe smokers, defined as consuming more than 10 cigarettes per day.

Substance Abuse: History of alcohol or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Test: microRepair ABX Mousse
Patients in this group will apply a mouthwash in mousse form enriched with microRepair particles and an Antibacterial Complex (ABX). The product is designed to bind to the oral mucosa, stimulating tissue regeneration and providing antibacterial protection to the post-extraction site.
Other: microRepair ABX Mousse
Topical application of the mousse on the surgical wound starting from the day after the extraction. The mousse is specifically formulated to promote healing through microparticles that accelerate tissue repair and an antibacterial complex to prevent localized infections.
Active Comparator: Group Control: CHX 0.20%
Patients in this group will use a standard liquid mouthwash containing 0.20% Chlorhexidine (CHX). This represents the traditional antiseptic protocol for managing oral hygiene and preventing infection in the post-operative period.
Other: CHX mouthwash 0.20%
Application of 0.20% Chlorhexidine liquid mouthwash. Used as a control treatment to evaluate the comparative effectiveness of the test product in reducing plaque, pain, and inflammation while promoting socket healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index at the Tooth Extraction Site
Time Frame: From enrollment to the end of treatment at 15 days
Assessment of the presence or absence of visible bacterial plaque at the tooth extraction site, recorded as a dichotomous variable (Yes/No). The absence of plaque indicates better oral hygiene and a lower risk of postoperative infection.
From enrollment to the end of treatment at 15 days
Gingival Condition of the Peri-Alveolar Tissue
Time Frame: From enrollment to the end of treatment at 15 days
Evaluation of the gingival tissue surrounding the extraction socket based on the presence or absence of clinical signs of inflammation (e.g., redness, edema), recorded as a dichotomous variable (Yes/No). The absence of inflammation indicates healthier gingival tissue.
From enrollment to the end of treatment at 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction with the Product
Time Frame: At 15 days post-treatment

Assessment of patient-reported satisfaction with the product using a structured questionnaire administered at the end of the treatment period.

The questionnaire will evaluate overall acceptability of the product, including:

  • taste
  • comfort during application
  • perceived effectiveness
  • preference compared to traditional treatment
  • perceived improvement in sensitivity Each item will be recorded as a dichotomous variable (Yes/No) (e.g., satisfied vs. not satisfied). Higher frequency of positive responses indicates greater patient satisfaction.
At 15 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1957/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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