PeriodontitisNCT06341439
Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX®
A study testing Mouthwash with chlorhexidine 0,12% and CITROX and Mouthwash with chlorhexidine 0,12% in people with Periodontitis, run by University of L'Aquila at 1 site in Italy.
Trial summary
The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Mouthwash with chlorhexidine 0,12% and CITROX and Mouthwash with chlorhexidine 0,12%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and ASA II patients;
- Age > 21 years;
- Non-smokers or smokers < 5 cig/day;
- Presence of periodontal disease;
- >10 natural teeth;
- At least 2 teeth with pockets ≥5mm;
- Indications for carrying out at least one SRP (scaling and root planing) session;
- Signing of the written informed consent to participate in the study.
Who cannot join
- Severe general medical pathologies;
- Immunodeficiency states;
- Radiotherapy in the head and neck region;
- Uncontrolled diabetes or hypertension;
- Smokers >5 cigs/day;
- Impossibility to carry out homogeneous and continuous follow-up;
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- Documented allergy to chlorhexidine or hyaluronic acid;
- Taking drugs that cause alterations in the gums and oral mucosa;
- Pregnancy or breastfeeding;
- Presence of removable prostheses;
- Periodontal treatment in the previous 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX® as a Support to Non-surgical Periodontal Therapy: a Randomized Controlled Triple-blind Clinical Trial
The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are:
- Is the response to periodontal therapy better if mouthwashes containing bioflavonoids are used as a support to non surgical periodontal therapy?
- What is the patients' perception?
Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy.
Read the detailed description
At baseline, all participants underwent received comprehensive periodontal examination, full-mouth intraoral radiographic analysis and received oral hygiene instruction. All treatments were performed by the same experienced clinician (M.G.L.) After completing NSPT, patients were randomly assigned to the test- or control group through an online random number generator (random.org; www.random.org). Test group participants received a 300 ml bottle of mouthwash containing 0,12% CHX combined with organic acids and bioflavonoids, while the control group received a 300 ml bottle of 0.12% CHX mouthwash. Both bottles were unlabeled to prevent identification by either the patients or the clinician. All participants were instructed to rinse with the undiluted mouthwash twice daily (morning and evening) for 60 seconds over 14 days following subgingival instrumentations. This regimen aligns with the standard use of chlorhexidine mouthwashes. Oral hygiene instructions were provided after both supragingival debridement and subgingival instrumentations with additional training in the use of interdental devices as necessary.
Patients were recalled for follow-up assessments at 14 days (T2), 2 months (T3) and 6 months (T4). In these sessions, oral hygiene instructions were reinforced as needed. During the follow-up, no additional periodontal treatments were performed. Patients were subsequently enrolled in a maintenance care program, involving routine professional cleanings every 6 months. Data collected from baseline (T0) to 6 months (T4) were used for the present analysis.
- Conditions
- Periodontitis
- Being tested
- Mouthwash with chlorhexidine 0,12% and CITROX, Mouthwash with chlorhexidine 0,12%
- Keywords
- Periodontitis, Non-surgical therapy, Chlorhexidine, Mouthwash, Plaque, Randomized trial
- Medical subject headings
- Periodontitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthwash with chlorhexidine 0,12% and CITROXDevice
Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.
Mouthwash with chlorhexidine 0,12%Device
Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Mouthwash containing 0,12% chlorhexidine + bioflavonoids Receives: Device: Mouthwash with chlorhexidine 0,12% and CITROX |
| Control Group | Active comparator | Mouthwash containing 0,12% chlorhexidine Receives: Device: Mouthwash with chlorhexidine 0,12% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full mouth bleeding score (FMBS)
The FMBS indicate the percentage of bleeding sites out of the total.
Measured: baseline, 14 days, 2 months, 6 months
Full mouth plaque score (FMPS)
The FMPS indicate the percentage of sites with plaque out of the total.
Measured: baseline, 14 days, 2 months, 6 months
Probing Depth (PD)
Effects on post-treatment healing: the Probing Depth was measured in mm
Measured: baseline, 2 months, 6 months
Gingival Index (GI)
Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)
Measured: baseline, 14 days, 2 months, 6 months
Plaque Index (PI)
Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)
Measured: baseline, 14 days, 2 months, 6 months
Secondary outcomes (1)
Patient Reported Outcome Measure (PROMS)
Visual Analogue Scale (VAS) in the form of a questionnaire to evaluate post-op pain, post-op sensitivity, taste alteration, appearance of staining and pleasantness of the mouthrinse used. The minimum value is 0 while the maximum value is 10. For all questions the best value is 0 and the worst 10, except for pleasantness.
Measured: 2 weeks post non-surgical periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Jun 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Marchetti, University of L'Aquila
- Investigators
- Enrico Marchetti, DDS, MS, PhD, Principal investigator, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341439
- Sponsor's protocol ID
- Prot. 001_2023
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD could be available to other researchers. Data will anonymized and delivered under request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX® as a Support to Non-surgical Periodontal Therapy: a Randomized Controlled Triple-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06341439
- Acronym / sponsor ID
- Prot. 001_2023
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Non-surgical therapy, Chlorhexidine, Mouthwash, Plaque, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 2 Apr 2024 (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 goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are:
- Is the response to periodontal therapy better if mouthwashes containing bioflavonoids are used as a support to non surgical periodontal therapy?
- What is the patients' perception?
Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy.
Detailed description
At baseline, all participants underwent received comprehensive periodontal examination, full-mouth intraoral radiographic analysis and received oral hygiene instruction. All treatments were performed by the same experienced clinician (M.G.L.) After completing NSPT, patients were randomly assigned to the test- or control group through an online random number generator (random.org; www.random.org). Test group participants received a 300 ml bottle of mouthwash containing 0,12% CHX combined with organic acids and bioflavonoids, while the control group received a 300 ml bottle of 0.12% CHX mouthwash. Both bottles were unlabeled to prevent identification by either the patients or the clinician. All participants were instructed to rinse with the undiluted mouthwash twice daily (morning and evening) for 60 seconds over 14 days following subgingival instrumentations. This regimen aligns with the standard use of chlorhexidine mouthwashes. Oral hygiene instructions were provided after both supragingival debridement and subgingival instrumentations with additional training in the use of interdental devices as necessary.
Patients were recalled for follow-up assessments at 14 days (T2), 2 months (T3) and 6 months (T4). In these sessions, oral hygiene instructions were reinforced as needed. During the follow-up, no additional periodontal treatments were performed. Patients were subsequently enrolled in a maintenance care program, involving routine professional cleanings every 6 months. Data collected from baseline (T0) to 6 months (T4) were used for the present analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Mouthwash with chlorhexidine 0,12% and CITROXMouthwash containing 0,12% chlorhexidine + bioflavonoids |
| Control Group | Active comparator | Device: Mouthwash with chlorhexidine 0,12%Mouthwash containing 0,12% chlorhexidine |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ASA I and ASA II patients;
- Age > 21 years;
- Non-smokers or smokers < 5 cig/day;
- Presence of periodontal disease;
- >10 natural teeth;
Key exclusion criteria (11 listed)
- Severe general medical pathologies;
- Immunodeficiency states;
- Radiotherapy in the head and neck region;
- Uncontrolled diabetes or hypertension;
- Smokers >5 cigs/day;
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 |
|---|---|---|
| Mouthwash with chlorhexidine 0,12% and CITROXPatients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing. | Device | Test Group |
| Mouthwash with chlorhexidine 0,12%Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing. | Device | Control Group |
Primary outcome
Full mouth bleeding score (FMBS)
Time frame: baseline, 14 days, 2 months, 6 months
The FMBS indicate the percentage of bleeding sites out of the total.
Full mouth plaque score (FMPS)
Time frame: baseline, 14 days, 2 months, 6 months
The FMPS indicate the percentage of sites with plaque out of the total.
Probing Depth (PD)
Time frame: baseline, 2 months, 6 months
Effects on post-treatment healing: the Probing Depth was measured in mm
Gingival Index (GI)
Time frame: baseline, 14 days, 2 months, 6 months
Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)
Plaque Index (PI)
Time frame: baseline, 14 days, 2 months, 6 months
Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)
1 secondary outcome
Patient Reported Outcome Measure (PROMS)
Time frame: 2 weeks post non-surgical periodontal therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes. IPD could be available to other researchers. Data will anonymized and delivered under request.
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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.
Enrico Marchetti, DDS, MS, PhD principal investigator
University of L'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthwash with chlorhexidine 0,12% and CITROX and Mouthwash with chlorhexidine 0,12% in people with Periodontitis, run by University of L'Aquila 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 21 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Full mouth bleeding score (FMBS) (time frame: baseline, 14 days, 2 months, 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2025.