PeriodontitisNCT05548361
The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis
A study testing active chlorhexidine and active probiotic in people with Periodontitis and Chlorhexidine, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is determining the additional effect of a 2-week home usage of chlorhexidine in periodontitis patients undergoing scaling and root planing supplemented with a dual-strain probiotic lozenge. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Chlorhexidine, Probiotic
- What is being tested?
- active chlorhexidine and active probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with generalized (>30% of teeth affected) periodontitisstage III and IV periodontitis, grade B or C (C only with smoker modifier) = generalized chronic periodontitis including smokers
- A minimum of three natural teeth in each quadrant, excluding third molars
- Willing and able to give informed consent
- Not more than 50% of the patients in each group will be smokers.
- Smokers should smoke between 10 to 40 cigarettes a day
Who cannot join
- Patients with localized periodontitis or periodontitis stage I or II or grade A or grade C or grade C with diabetes modifier
- Patients with orthodontic appliances (removable or fixed)
- Pregnant or lactating woman
- Patients with a history of systemic diseases that may correlate with periodontal health, such as diabetesrheumatic fever, liver or kidney disease, and neurological deficiencies
- Patients taking medication which may affect the periodontium (bisphosphonates, phenytoin, cyclosporin, nifidepine, chronic use of non-steroidal anti-inflammatory drugs)
- Patient who had taken systemic antibiotics up to 3 months prior to treatment or medical conditions requiring prophylactic antibiotic coverage
- Participation in any other clinical study
- Tobacco chewing or sniffing
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova university Faculty of Dentistry
Adana
About this study
The aim of this study is determining the additional effect of a 2-week home usage of chlorhexidine in periodontitis patients undergoing scaling and root planing supplemented with a dual-strain probiotic lozenge.
- Conditions
- Periodontitis, Chlorhexidine, Probiotic
- Being tested
- active chlorhexidine and placebo probiotic, placebo chlorhexidine and active probiotic, active chlorhexidine and active probiotic
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active chlorhexidine and placebo probioticCombination product
the randomized patients will be receive active chlorhexidine rinse and placebo probiotic
placebo chlorhexidine and active probioticCombination product
the randomized patients will receive placebo chlorhexidine rinse and active probiotic
active chlorhexidine and active probioticCombination product
the randomized patients will receive active chlorhexidine rinse and active probiotic
| Study group | Role | What they receive |
|---|---|---|
| Active Chx | Experimental | This group will receive active chlorhexidine and placebo probiotics Receives: Combination Product: active chlorhexidine and placebo probiotic |
| Active probiotics | Experimental | This group will receive placeo chlorhexidine and active probiotics Receives: Combination Product: placebo chlorhexidine and active probiotic |
| Active Chx & probiotics | Experimental | This group will receive active chlorhexidine and active probiotics Receives: Combination Product: active chlorhexidine and active probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing pocket depth
the distance between gingival margin and pocket base in millimeters
Measured: 6 months
Secondary outcomes (5)
percentage of patients in low risk for disease progression
having less than 5 sites with probing pocket depth of 5 mm or more at the end of the trial.
Measured: 6 months
gingival recession
the distance between cementoenamel junction and gingival margin in millimeters
Measured: 6 months
clinical attachment level
the distance between cementoenamel junction and pocket base in millimeters
Measured: 6 months
full mouth bleeding and plaque score
the scores of bleeding on probing (positive or negative)
Measured: 6 months
microbial outcomes
pcr analysis of plaque samples (mean log10 cfg/ml)
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 posted21 Sep 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2024
- Study completion1 Dec 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.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB, Sunstar
- Responsible party
- Principal investigator, Mustafa Ozcan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548361
- Sponsor's protocol ID
- CukurovaU-PerII
- Status last verified
- Jun 2025
- First submitted
- 12 Sep 2022
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis
- ClinicalTrials.gov ID
- NCT05548361
- Acronym / sponsor ID
- CukurovaU-PerII
- Conditions
- Periodontitis, Chlorhexidine, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- BioGaia AB, Sunstar
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 21 Sep 2022 (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 aim of this study is determining the additional effect of a 2-week home usage of chlorhexidine in periodontitis patients undergoing scaling and root planing supplemented with a dual-strain probiotic lozenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Chx | Experimental | Combination Product: active chlorhexidine and placebo probioticThis group will receive active chlorhexidine and placebo probiotics |
| Active probiotics | Experimental | Combination Product: placebo chlorhexidine and active probioticThis group will receive placeo chlorhexidine and active probiotics |
| Active Chx & probiotics | Experimental | Combination Product: active chlorhexidine and active probioticThis group will receive active chlorhexidine and active probiotics |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with generalized (>30% of teeth affected) periodontitisstage III and IV periodontitis, grade B or C (C only with smoker modifier) = generalized chronic periodontitis including smokers
- A minimum of three natural teeth in each quadrant, excluding third molars
- Willing and able to give informed consent
- Not more than 50% of the patients in each group will be smokers.
- Smokers should smoke between 10 to 40 cigarettes a day
Key exclusion criteria (8 listed)
- Patients with localized periodontitis or periodontitis stage I or II or grade A or grade C or grade C with diabetes modifier
- Patients with orthodontic appliances (removable or fixed)
- Pregnant or lactating woman
- Patients with a history of systemic diseases that may correlate with periodontal health, such as diabetesrheumatic fever, liver or kidney disease, and neurological deficiencies
- Patients taking medication which may affect the periodontium (bisphosphonates, phenytoin, cyclosporin, nifidepine, chronic use of non-steroidal anti-inflammatory drugs)
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 |
|---|---|---|
| active chlorhexidine and placebo probioticthe randomized patients will be receive active chlorhexidine rinse and placebo probiotic | Combination product | Active Chx |
| placebo chlorhexidine and active probioticthe randomized patients will receive placebo chlorhexidine rinse and active probiotic | Combination product | Active probiotics |
| active chlorhexidine and active probioticthe randomized patients will receive active chlorhexidine rinse and active probiotic | Combination product | Active Chx & probiotics |
Primary outcome
probing pocket depth
Time frame: 6 months
the distance between gingival margin and pocket base in millimeters
5 secondary outcomes
percentage of patients in low risk for disease progression
Time frame: 6 months
gingival recession
Time frame: 6 months
clinical attachment level
Time frame: 6 months
full mouth bleeding and plaque score
Time frame: 6 months
microbial outcomes
Time frame: 6 months
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 15 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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 active chlorhexidine and active probiotic in people with Periodontitis and Chlorhexidine, run by Cukurova University at 1 site in Turkey (Türkiye).
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 8 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 15 Jun 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 Turkey (Türkiye). 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?
probing pocket depth (time frame: 6 months). 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 15 Jun 2025.