Post-Extraction Healing: microRepair vs Chlorhexidine

NCT07555366 | Recruiting

• 1 other identifier: 1957/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. The primary objective is to determine if the microRepair ABX technology enhances tissue regeneration and reduces post-operative complications.

Conditions

Endodontic Issue; Periodontal Issues

Keywords

tooth extraction; abx; chx

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to the end of treatment at 15 days

Secondary Outcomes (1)

• Patient Satisfaction with the Product

  At 15 days post-treatment

Study Arms (2)

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.

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.

Other: CHX mouthwash 0.20%

Interventions

microRepair ABX Mousse OTHER

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.

Group Test: microRepair ABX Mousse

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.

Group Control: CHX 0.20%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza università di Roma

Roma, RM, 00161, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 22654359 BACKGROUND

Central Study Contacts

Fabrizio Guerra

CONTACT

3283150627; fabrizio.guerra@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, pHd

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 29, 2026
• Study Start: September 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)