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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Endodontic Issue

Clinical Trials on microRepair ABX Mousse

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings