Endodontic Issue, Periodontal Issues
Conditions
Keywords
tooth extraction, abx, chx
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.
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
OTHERmicroRepair 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.
OTHERCHX 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.
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index at the Tooth Extraction Site | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction with the Product | 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. |
Countries
Italy
Contacts
CONTACTFabrizio Guerra
Outcome results
None listed