Sapienza università di Roma
Roma, RM, 00161, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT07555366
Post-Extraction Healing: microRepair vs 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.
Recruiting
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Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
microRepair ABX Mousse
OtherTopical 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%
OtherApplication 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 outcomes
-
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.
Secondary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Roma La Sapienza
Other
Registry information
Official study title
Evaluation of Healing in Post-Extraction Sockets Using microRepair Abx Mousse Mouthwash Versus 0.20% Chlorhexidine
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Apr 29, 2026
- Registry last updated
- Apr 29, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.