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Active Not RecruitingNCT07520968

ABX Versus CHX in NSPT: a RCT

Enamel-repair Microcrystal Mouthwash Enriched With an Antibacterial Complex (ABX) Versus Chlorhexidine (CHX) Mouthwash as an Adjunct to Non-surgical Periodontal Therapy

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
University of Roma La Sapienza · Academic / Other
Sex
All
Age
30 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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

Conditions

Interventions

TypeNameDescription
OTHERABX Mouthwash as adjunctive to non surgical periodontal treatmentGroup A: a novel mouthwash with microRepair ABX will be used for the first timen in adjunct to non surgical periodontal therapy
OTHERCHX as adjunctive to non surgical periodontal treatmentGroup B - chlorhexidine mouthwash in adjunct to nonsurgical periodontal therapy

Timeline

Start date
2025-09-09
Primary completion
2026-11-01
Completion
2027-03-01
First posted
2026-04-09
Last updated
2026-04-09

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07520968. Inclusion in this directory is not an endorsement.