PeriodontitisNCT06028867
Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis
A study testing Non-surgical periodontal treatment in people with Periodontitis, run by University of Catania at 1 site in Italy.
Trial summary
Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.2% + Sodium DNA and Chlorhexidine 0.2% at two weeks… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jan 2020to 20 Apr 2024
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically diagnosed with stage III or IV periodontitis according to the EFP/AAP 2017 criteria.
Who cannot join
- Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
- Systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis: a Randomized-controlled Clinical Trial
Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.2% + Sodium DNA and Chlorhexidine 0.2% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis.
Read the detailed description
Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCTstudy is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.2% + Sodium DNA and Chlorhexidine 0.20% for 2 weeks of therapy, compared with a placebo, on patients with stage III or IV periodontitis. The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
- Conditions
- Periodontitis
- Being tested
- Non-surgical periodontal treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
Subgingival biofilm ultrasonic debridement
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine 0,2% + Sodium DNA mouthwash | Experimental | Patients are treated with a mouthwash containing Chlorhexidine 0,2% + Sodium DNA Receives: Procedure: Non-surgical periodontal treatment |
| Chlorhexidine 0,20% mouthwash | Active comparator | Patients are treated with a mouthwash containing Chlorhexidine 0,20% Receives: Procedure: Non-surgical periodontal treatment |
| Placebo mouthwash | Placebo comparator | Patients are treated with a placebo mouthwash Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subgingival biofilm
Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction
Measured: 6 months
FMBS
Full mouth bleeding score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start24 Jan 2020
- Primary completion30 Jan 2024
- Study completion20 Apr 2024
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
- Model description
- The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028867
- Sponsor's protocol ID
- 121-29
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis: a Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06028867
- Acronym / sponsor ID
- 121-29
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 8 Sep 2023 (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.
Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.2% + Sodium DNA and Chlorhexidine 0.2% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis.
Detailed description
Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCTstudy is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.2% + Sodium DNA and Chlorhexidine 0.20% for 2 weeks of therapy, compared with a placebo, on patients with stage III or IV periodontitis. The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine 0,2% + Sodium DNA mouthwash | Experimental | Procedure: Non-surgical periodontal treatmentPatients are treated with a mouthwash containing Chlorhexidine 0,2% + Sodium DNA |
| Chlorhexidine 0,20% mouthwash | Active comparator | Procedure: Non-surgical periodontal treatmentPatients are treated with a mouthwash containing Chlorhexidine 0,20% |
| Placebo mouthwash | Placebo comparator | Procedure: Non-surgical periodontal treatmentPatients are treated with a placebo mouthwash |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically diagnosed with stage III or IV periodontitis according to the EFP/AAP 2017 criteria.
Key exclusion criteria (3 listed)
- Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
- Systemic diseases.
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 |
|---|---|---|
| Non-surgical periodontal treatmentSubgingival biofilm ultrasonic debridement | Procedure or surgery | Chlorhexidine 0,2% + Sodium DNA mouthwash, Chlorhexidine 0,20% mouthwash, Placebo mouthwash |
Primary outcome
Subgingival biofilm
Time frame: 6 months
Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction
FMBS
Time frame: 6 months
Full mouth bleeding score
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 11 Aug 2026.
- 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 Non-surgical periodontal treatment in people with Periodontitis, run by University of Catania 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 1 inclusion and 3 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 11 Aug 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. Some participants in this study may receive a placebo. 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?
Subgingival biofilm (time frame: 6 months). 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?
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 11 Aug 2026.