Periodontal DiseaseABXvsCHXNCT07520968
ABX Versus CHX in NSPT
A study testing ABX Mouthwash as adjunctive to non surgical periodontal treatment and CHX as adjunctive to non surgical periodontal treatment in people with Periodontal Disease and Periodontal Disease Stage 2, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Periodontal Disease, Periodontal Disease Stage 2, Periodontal Disease, AVDC Stage 3
- What is being tested?
- ABX Mouthwash as adjunctive to non surgical periodontal treatment and CHX as adjunctive to non surgical periodontal treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 9 Sep 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with Stage IV periodontal disease;
- HbA1c > 7% 3 ASA > III 4 Severe smokers 5 Patients already using the study products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- ABX Mouthwash as adjunctive to non surgical periodontal treatment, CHX as adjunctive to non surgical periodontal treatment
- Keywords
- periodontal disease, Nspt, scaling and root planing
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX Mouthwash as adjunctive to non surgical periodontal treatmentOther
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 treatmentOther
Group B - chlorhexidine mouthwash in adjunct to nonsurgical periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A - Test group | Experimental | NSPT + ABX Receives: Other: ABX Mouthwash as adjunctive to non surgical periodontal treatment |
| Group B - Control Group | Active comparator | NSPT + CHX 0,12% Receives: Other: CHX as adjunctive to non surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from baseline to 12 and 24 weeks after full mouth disinfection
Secondary outcomes (4)
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
Measured: 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.
Measured: from baseline to 12 and 24 weeks after full mouth disinfection
dentin hypersensitivity
dentin hypersensitivity measured using a VAS followingair stimulus
Measured: baseline, 12 weeks and 24 weeks
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.
Measured: 2 weeks after the non surgical periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start9 Sep 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Guerra, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520968
- Sponsor's protocol ID
- 1576/2025
- Acronym
- ABXvsCHX
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12010523
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enamel-repair Microcrystal Mouthwash Enriched With an Antibacterial Complex (ABX) Versus Chlorhexidine (CHX) Mouthwash as an Adjunct to Non-surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT07520968
- Acronym / sponsor ID
- ABXvsCHX / 1576/2025
- Keywords
- periodontal disease, Nspt, scaling and root planing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Test group | Experimental | Other: ABX Mouthwash as adjunctive to non surgical periodontal treatmentNSPT + ABX |
| Group B - Control Group | Active comparator | Other: CHX as adjunctive to non surgical periodontal treatmentNSPT + CHX 0,12% |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with Stage IV periodontal disease;
- HbA1c > 7% 3 ASA > III 4 Severe smokers 5 Patients already using the study products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX 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 | Other | Group A - Test group |
| CHX as adjunctive to non surgical periodontal treatmentGroup B - chlorhexidine mouthwash in adjunct to nonsurgical periodontal therapy | Other | Group B - Control Group |
Primary outcome
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.
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.
4 secondary outcomes
clinical attachment level - CAL
Time frame: From baseline to 12 and 24 weeks after full mouth disinfection
Full mouth plaque score
Time frame: from baseline to 12 and 24 weeks after full mouth disinfection
dentin hypersensitivity
Time frame: baseline, 12 weeks and 24 weeks
Patient satisfaction
Time frame: 2 weeks after the non surgical periodontal treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 12010523Cobb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABX Mouthwash as adjunctive to non surgical periodontal treatment and CHX as adjunctive to non surgical periodontal treatment in people with Periodontal Disease and Periodontal Disease Stage 2, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: From enrollment to the end of treatment at 12 weeks and at 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07520968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.