Endodontic IssueNCT07555366
Post-Extraction Healing: microRepair vs Chlorhexidine
A study testing microRepair ABX Mousse and CHX mouthwash 0.20% in people with Endodontic Issue and Periodontal Issues, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Endodontic Issue, Periodontal Issues
- What is being tested?
- microRepair ABX Mousse and CHX mouthwash 0.20%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Sapienza università di Roma
Roma, RM, 00161
Fabrizio Guerra, 3283150627, prof.fabrizio.guerra@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Endodontic Issue, Periodontal Issues
- Being tested
- microRepair ABX Mousse, CHX mouthwash 0.20%
- Keywords
- tooth extraction, abx, chx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microRepair ABX MousseOther
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.
CHX mouthwash 0.20%Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Test: microRepair ABX Mousse | Experimental | 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. Receives: Other: microRepair ABX Mousse |
| Group Control: CHX 0.20% | Active comparator | 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. Receives: Other: CHX mouthwash 0.20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index at the Tooth Extraction Site
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.
Measured: From enrollment to the end of treatment at 15 days
Gingival Condition of the Peri-Alveolar Tissue
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.
Measured: From enrollment to the end of treatment at 15 days
Secondary outcomes (1)
Patient Satisfaction with the Product
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.
Measured: At 15 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Sep 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endodontic IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Guerra, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555366
- Sponsor's protocol ID
- 1957/2024
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sridhar V, Wali GG, Shyla HN. Evaluation of the perioperative use of 0.2% chlorhexidine gluconate for the prevention of alveolar osteitis after the extraction of impacted mandibular third molars: a clinical study. J Maxillofac Oral Surg. 2011 Jun;10(2):101-11. doi: 10.1007/s12663-011-0206-0. Epub 2011 Apr 22.
PubMed 22654359
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Healing in Post-Extraction Sockets Using microRepair Abx Mousse Mouthwash Versus 0.20% Chlorhexidine
- ClinicalTrials.gov ID
- NCT07555366
- Acronym / sponsor ID
- 1957/2024
- Conditions
- Endodontic Issue, Periodontal Issues
- Keywords
- tooth extraction, abx, chx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Test: microRepair ABX Mousse | Experimental | Other: microRepair ABX MoussePatients 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. |
| Group Control: CHX 0.20% | Active comparator | Other: CHX mouthwash 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range: Patients between 18 and 75 years of age.
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microRepair ABX MousseTopical 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. | Other | Group Test: microRepair ABX Mousse |
| 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. | Other | Group Control: CHX 0.20% |
Primary outcome
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.
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.
1 secondary outcome
Patient Satisfaction with the Product
Time frame: At 15 days post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 22654359Sridhar V, Wali GG, Shyla HN. Evaluation of the perioperative use of 0.2% chlorhexidine gluconate for the prevention of alveolar osteitis after the extraction of impacted mandibular third molars: a clinical study. J Maxillofac Oral Surg. 2011 Jun;10(2):101-11. doi: 10.1007/s12663-011-0206-0. Epub 2011 Apr 22.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microRepair ABX Mousse and CHX mouthwash 0.20% in people with Endodontic Issue and Periodontal Issues, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Guerra (3283150627, fabrizio.guerra@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index at the Tooth Extraction Site (time frame: From enrollment to the end of treatment at 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07555366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.