Post-Extraction Healing: microRepair vs Chlorhexidine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: microRepair ABX Mousse, CHX mouthwash 0.20%.
- Who it may be relevant to
- Registry conditions: Endodontic Issue, Periodontal Issues. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Healing in Post-Extraction Sockets Using microRepair Abx Mousse Mouthwash Versus 0.20% Chlorhexidine
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Plaque Index at the Tooth Extraction Site [Time frame: 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]
Secondary outcome measures (1)
- Patient Satisfaction with the Product [Time frame: At 15 days post-treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Sapienza università di Roma — Roma
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. PMID 22654359
Identifiers
NCT: NCT07555366 · 1957/2024