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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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Inclusion Criteria:
Age range: Patients between 18 and 75 years of age.
Indication for tooth extraction: Specifically for cases involving:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabrizio Guerra | Contact | 3283150627 | fabrizio.guerra@uniroma1.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza università di Roma | Recruiting | Roma | RM | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22654359 | Background | 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. |
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| 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. |
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| At 15 days post-treatment |