ABX Versus CHX in NSPT (ABXvsCHX)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontal Disease; Periodontal Disease, AVDC Stage 3; Periodontal Disease Stage 2
• Intervention / Treatment: Other: ABX Mouthwash as adjunctive to non surgical periodontal treatment; Other: CHX as adjunctive to non surgical periodontal treatment

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • rm
    • Roma, rm, Italy, 00161
      • Fabrizio Guerra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - Test group; NSPT + ABX	Other: ABX Mouthwash as adjunctive to non surgical periodontal treatment; Group A: a novel mouthwash with microRepair ABX will be used for the first timen in adjunct to non surgical periodontal therapy
Active Comparator: Group B - Control Group; NSPT + CHX 0,12%	Other: CHX as adjunctive to non surgical periodontal treatment; Group B - chlorhexidine mouthwash in adjunct to nonsurgical periodontal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth	Probing Depth (PD), measured in millimeters (mm) using a PCP 15 UNC periodontal probe. PD represents the distance from the gingival margin to the base of the periodontal pocket. The measurement range is from 0 to 15 mm. Higher values indicate deeper periodontal pockets and a worse periodontal condition.	From enrollment to the end of treatment at 12 weeks and at 24 weeks
full mouth bleeding score	Full Mouth Bleeding Score (FMBS), expressed as the percentage (%) of sites exhibiting bleeding on probing out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate more gingival inflammation and a worse outcome.	from baseline to 12 and 24 weeks after full mouth disinfection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dentin hypersensitivity	dentin hypersensitivity measured using a VAS followingair stimulus	baseline, 12 weeks and 24 weeks
clinical attachment level - CAL	Clinical Attachment Level (CAL), measured in millimeters (mm) using a PCP 15 UNC periodontal probe. CAL represents the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket. The measurement range is from 0 to 15 mm. Higher values indicate greater attachment loss and a worse periodontal outcome	From baseline to 12 and 24 weeks after full mouth disinfection
Full mouth plaque score	Full Mouth Plaque Score (FMPS), expressed as the percentage (%) of sites with visible plaque out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate poorer oral hygiene and a worse outcome.	from baseline to 12 and 24 weeks after full mouth disinfection
Patient satisfaction	Patient satisfaction, assessed using a structured questionnaire evaluating comfort, perceived effectiveness, and overall satisfaction with the treatment. Each item is recorded as a dichotomous response (Yes/No). Responses are summarized as the percentage (%) of positive ("Yes") answers out of the total number of questions. The scale ranges from 0% to 100%, where higher percentages indicate greater patient satisfaction and a better outcome.	2 weeks after the non surgical periodontal treatment

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Publications and helpful links

General Publications

• Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. J Clin Periodontol. 2002 May;29 Suppl 2:6-16.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: periodontal disease; scaling and root planing; Nspt
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases
• Other Study ID Numbers: 1576/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No