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NCT Number: NCT07520968

ABX Versus CHX in NSPT

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Disease Stage 2 Periodontal Disease, AVDC Stage 3 Periodontal Diseases Stomatognathic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fabrizio Guerra

Roma, rm, 00161, Italy

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Stage I, II and III periodontal disease;
  • Age between 30 and 70 years;
  • ASA I or II patients;
  • Light smokers (<10 cigarettes per day);
  • Patients not already using the study products

Exclusion criteria

  • Patients with Stage IV periodontal disease;
  • HbA1c > 7% 3 ASA > III 4 Severe smokers 5 Patients already using the study products

Treatment and study plan

ABX Mouthwash as adjunctive to non surgical periodontal treatment

Other

Group A: a novel mouthwash with microRepair ABX will be used for the first timen in adjunct to non surgical periodontal therapy

CHX as adjunctive to non surgical periodontal treatment

Other

Group B - chlorhexidine mouthwash in adjunct to nonsurgical periodontal therapy

Primary outcomes

  1. Probing depth

    Time frame: From enrollment to the end of treatment at 12 weeks and at 24 weeks

    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.

  2. full mouth bleeding score

    Time frame: from baseline to 12 and 24 weeks after full mouth disinfection

    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.

Secondary outcomes

  1. clinical attachment level - CAL

    Time frame: From baseline to 12 and 24 weeks after full mouth disinfection

    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

  2. Full mouth plaque score

    Time frame: from baseline to 12 and 24 weeks after full mouth disinfection

    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.

  3. dentin hypersensitivity

    Time frame: baseline, 12 weeks and 24 weeks

    dentin hypersensitivity measured using a VAS followingair stimulus

  4. Patient satisfaction

    Time frame: 2 weeks after the non surgical periodontal treatment

    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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: ABXvsCHX

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Apr 21, 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.

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