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Active (not recruiting) Not applicable NCT07520968

ABX Versus CHX in NSPT

No applicable phase (e.g. observational)
Conditions: Periodontal Disease Periodontal Disease Stage 2 Periodontal Disease, AVDC Stage 3

Sponsor: University of Roma La Sapienza

trial.available_in: БГ
Overview
The study aims to compare the efficacy of a novel mouthwash based on microRepair ABX and an antibacterial complex with that of 0.12% chlorhexidine, both used as adjuncts to scaling and root planing.
Description
This study will be conducted in the Department of Odontostomatological and Maxillofacial sciences, in the Screening and Prevention Unit directed by me. Study Population Subjects diagnosed with periodontal disease and requiring non-surgical periodontal therapy were enrolled. Sample Size A total of 40 patients were included in the study, with 20 subjects allocated to each treatment group. Group A- TEST GROUP: NSPT+ ABX; GROUP B- CONTROL GROUP: NSPT+ CHX. All participants underwent a comprehensive periodontal examination, including full-mouth periodontal charting. Standardized intraoral periapical radiographs were obtained using positioning devices to assess radiographic bone loss. All patients subsequently received non-surgical periodontal therapy (NSPT) following a full-mouth disinfection protocol, performed with both hand and ultrasonic instruments. Oral hygiene instructions were reinforced at each scheduled visit. A first re-evaluation was conducted at 8 weeks, and a second re-evaluation at 6 months to assess periodontal stability. Patients in the control group received NSPT in combination with a 0.12% chlorhexidine mouthwash, administered twice daily for 60 seconds over a 14-day period starting immediately after completion of mechanical instrumentation. Patients in the test group received NSPT in combination with a high-density Biorepair Plus mouthwash, administered twice daily for 60 seconds over a 14-day period starting immediately after completion of mechanical instrumentation
Who can participate
Inclusion Criteria: 1. Patients with Stage I, II and III periodontal disease; 2. Age between 30 and 70 years; 3. ASA I or II patients; 4. Light smokers (\<10 cigarettes per day); 5. Patients not already using the study products Exclusion Criteria: 1. Patients with Stage IV periodontal disease; 2. HbA1c \> 7% 3 ASA \> III 4 Severe smokers 5 Patients already using the study products
Interventions
ABX Mouthwash as adjunctive to non surgical periodontal treatment
OTHER
CHX as adjunctive to non surgical periodontal treatment
OTHER
Locations 1
Italy (1)
Fabrizio Guerra
Roma , rm
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
30 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
09.09.2025
Completion date
01.03.2027
Registry ID
NCT07520968
Source
clinicaltrials.gov
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