PeriodontitisNCT06967402
Comparative Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Periodontitis
A study testing Experimental (chlorhexidine) in people with Periodontitis and Periodontitis Stage II, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The focus of this study is on two types of mouthwashes - one containing a chlorhexidine (CHX) at 0.2% (CHX), and the other one containing CHX at a lower concentration of 0.12% with cetylpyridinium chloride (CPC). Both mouthwashes are used to help in the treatment of gum disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontitis Stage II, Periodontitis Stage III
- What is being tested?
- Experimental (chlorhexidine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Nov 2025to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients with at least 6 evaluable teeth in each quadrant, including minimum 1 molar and 1 premolar.
- Generalized stage II-III periodontitis patients.
- Baseline BOP > 25%.
- No known allergy or adverse effects to CHX or CPC
- Non-smokers, non-orthodontic patients, no concurrent or past antibiotics/medication known to affect periodontal status (i.e. calcium antagonists, phenytoin)/anti-inflammatory therapy (i.e. NASIDs) in the last 3 months, pregnant/breastfeeding, compliance to study procedures.
- ASA class I-II patients.
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- Either non-diabetic or with controlled diabetes (HbA1C<7).
- Normal/Elevated blood pressure (AHA - Systolic <130mmHg; Diastolic <80mmHg).
- No radiation/chemotherapy in the past 5 years
- No immunosuppression including drug induced immunosuppression.
- No participation in other clinical studies in the last 4 weeks.
- No administration of CHX or CPC in the last 3 months
- No periodontal treatment in the last 3 months.
Who cannot join
- Unable to provide written consent.
- Non-compliant study procedures.
- Patients with medical (including psychiatric) and pharmacotherapeutic histories that, in the investigator's opinion, may compromise the protocol.
- Patients requiring antibiotics prophylaxis for dental procedures.
- Patients with self-reported pregnancy or patients who are breastfeeding.
- Patients with history of use of systemic antibiotics, in combination with any form of periodontal treatment, within the past 3 months.
Show all 9Show fewer
- Patients with uncontrolled endocrine disease.
- Patients who are not compliant with the review protocol, leading to deviation of more than 1 week.
- Patients requiring the admission of systemic antibiotics, in combination with any form of dental treatment, during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
HKU Faculty of Dentistry, IAD - Clinical Research Centre
Hong Kong
Melissa Fok, PhD, +852-28590301, melfok@hku.hk
Hoi Lam Chan, BDS
About this study
Official title: Comparative Clinical Efficacy and Microbiological Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Severe Periodontitis
The focus of this study is on two types of mouthwashes - one containing a chlorhexidine (CHX) at 0.2% (CHX), and the other one containing CHX at a lower concentration of 0.12% with cetylpyridinium chloride (CPC). Both mouthwashes are used to help in the treatment of gum disease. CHX has been known for a long time for its effectiveness against plaque and mouth inflammation. It could inhibit and even kill them. However higher concentrations of CHX comes with unwanted side effect including altered taste, teeth staining and irritation in the mouth. Interestingly, these side effects seem to occur less frequently when a lower concentration CHX solution is used. CPC also combats bacteria by adhering quickly to the surfaces inside your mouth, although it has less substantivity than CHX, it has been shown to reduce plaque and gum inflammation effectively, and it typically causes fewer side effects than CHX. We hypothesize that this new formulation of CHX 0.12%+CPC mouthwash is non-inferior to CHX 0.2% in terms of its anti-plaque and anti-inflammatory properties while presenting with less side effects after 21 days of use. Microbiological samples and fluids from periodontal pockets will be collected before and after treatment for analysis of microbiological effects.
Read the detailed description
- Aim: To compare the effects of 2 formulations of antiseptics on clinical efficacy (reduction of gingival inflammation and plaque) and oral microbiome when used as an adjuvant in periodontal treatment.
- Hypothesis: HA: The study mouthwash (CLX 0.12% + CPC 0.05%) when used as an adjunct to step 1 periodontal therapy, is non-inferior to control mouthwash (CHX 0.2%) in terms of inflammation and plaque control.
- Primary outcome: Changes in full mouth Bleeding on Probing (BoP) at 2 months after 21 days daily use of test mouthwash as an adjunct to step 1 periodontal therapy compared to active control.
- Secondary outcome:
Changes in BoP at 21 days after baseline. Changes in Löe and Silness Gingival Index at 21 days and 2 months after baseline.
Changes in modified O'Leary plaque index and Turesky modification of Quigley-Hein plaque index at 21 days, 2 months after baseline.
Changes in Tongue Coating Index and Lobene Stain Index at 14, 21 days and 2 months after baseline.
Pocket probing depth (PPD) and clinical attachment level (CAL) changes 2 months after baseline.
Subgingival microbiological changes at 21 days and 2 months after baseline. Gingival cervical fluid volume and inflammatory biomarker profile changes at 21 days and 2 months.
Taste alteration and mucosal irritation at 14 days, 21 days and 2 months after baseline.
Changes in patient-reported outcome measures at 21 days and 2 months after baseline
- Being tested
- Experimental (chlorhexidine), Control (chlorhexidine with cetylpyridinium chloride)
- Keywords
- Mouthwash, Chlorhexidine, CPC, Periodontitis, Mouthrinse, cetylpyridinium chloride, Oral antiseptic
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (chlorhexidine)Other
Test group: administration of experimental antiseptic (CHX 0.12%+CPC 0.05%) for 3 weeks
Control (chlorhexidine with cetylpyridinium chloride)Other
Active comparator: administration of control antiseptic (CHX 0.2%) for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active control | Active comparator | CHX 0.2% Receives: Other: Control (chlorhexidine with cetylpyridinium chloride) |
| Experimental | Experimental | CHX 0.12%+CPC 0.05% Receives: Other: Experimental (chlorhexidine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Bleeding on probing (BoP)
% BoP will be assessed at 6 surfaces (mesiobuccal, mid buccal, disto-buccal, mesio-oral, mid-oral, disto-oral.) in a dichotomous manner (Mühlemann \& Son, 1971). Bleeding will be positive after 15 seconds of probing the gingival sulcus to the most apical stop. The percentage of the full mouth BoP will be reported.
Measured: 2 months
Secondary outcomes (12)
% Bleeding on probing (BoP)
% BoP will be assessed at 6 surfaces (mesiobuccal, mid buccal, disto-buccal, mesio-oral, mid-oral, disto-oral.) in a dichotomous manner (Mühlemann \& Son, 1971). Bleeding will be positive after 15 seconds of probing the gingival sulcus to the most apical stop. The percentage of the full mouth BoP will be reported.
Measured: 21 days
Macpherson modification of the Lobene Stain Index (MLSI)
Tooth staining assessment by the Macpherson modification of the Lobene Stain Index (MLSI) (L. M. Macpherson, K. W. Stephen, A. Joiner, F. Schäfer, \& E. Huntington, 2000) on index tooth (11, 12, 21, 22, 31, 32, 41, 42). If an incisor is missing, the nearest canine will serve as substitute where appropriate.
Measured: 21 days and 2 months
Full mouth plaque score
Full Mouth Plaque Score (FMPS) (O'Leary et al., 1972) will be measured as an indicator of oral hygiene on the mesial, distal, buccal and oral surfaces of each tooth.
The FMPS will be assessed with the following formula: Number of surfaces with plaque/Total number of surfaces x 100%
Measured: 21 days and 2 months
Clinical attachment level
CAL measures the distance from the cemento-enamel junction of the tooth to the base of the periodontal pocket.
CAL will be measured at baseline and 2 months by recording the distance from the cervical line to the bottom of the probable pocket at 6 sites (Mesio-buccal, mid-buccal, disto-buccal, mesio-oral, mid-oral and disto-oral) for each of the study teeth.
Measured: 2 months
Pocket probing depth (PPD)
PPD measures the distance from the free gingival margin to the base of the periodontal pocket. It will be measured at 6 sites (Mesio-buccal, mid-buccal, disto-buccal, mesio-oral, mid-oral and disto-oral) in the entire dentition.
Measured: 2 months
Patient-reported outcome measures for mouthwash (PROMs-MW)
A mouthwash-specific questionnaire consisting of 6 questions was constructed to assess the compliance and potential side effects associated with mouthwash use, including burning sensation, altered taste and unpleasant taste assessed on a visual analogue scale., taking reference from Navabi and coworkers (Navabi, Afshari, Kamyabi, \& Mohammadi, 2024). A higher score indicates a poorer patient-perceived experience.
Measured: 14 days, 21 days, 2 months
Oral health impact profile for chronic periodontitis (OHIP-CP)
Oral health impact profile for chronic periodontitis (OHIP-CP). The OHIP-CP is a condition-specific OHRQoL instrument for patients with chronic periodontitis consisting of 18 questions (He, Wang, Wei, \& Ji, 2017). Fifteen questions from the OHIP-CP Cantonese version was adopted from the translated and validated Chinese version of OHIP (Wong, Lo, \& McMillan, 2002). The remaining 3 questions were translated through forward translation, backward translation, expert committee process to reach a consensus. A higher score indicated poor oral health-related quality of life.
Measured: 21 days and 2 months
Löe and Silness Gingival Index
Löe and Silness Gingival Index (1963) (Loe \& Silness, 1963) will be performed on 4 gingival surfaces of index Ramfjord teeth (16, 21, 24, 36, 41, 44). Each of the four gingival areas (buccal, oral, mesial, distal) of the tooth is given a score from 0 to 3.
The scores of the 4 areas will be added and divided by 4 to give the GI for the tooth The scores for individual teeth may be grouped to have the GI for the group of teeth Finally, by adding the indices for the teeth and dividing by the total number of teeth examined, the Gl for the individual is obtained. The index for the subject is thus an average score for the areas examined.
Missing teeth from the Ramfjord index teeth (16, 21, 24, 36, 41, 44) will not be substituted.
Measured: 21 days and 2 months
Turesky modification of Quigley-Hein plaque index (TQHPI)
Turesky modification of Quigley-Hein plaque index (TQHPI)(Turesky et al.,1970) on Ramfjord teeth (16, 21, 24, 36, 41, 44) will be performed.
Each tooth will be divided into 6 surfaces (mesiobuccal, mid buccal, disto-buccal, mesio-oral, mid-oral, disto-oral.) Each surface will be given a score. The score of all sites will be summed and divided by the number of sites to have the individual tooth index The subject mean plaque score will be calculated by summing all the plaque indices of teeth and dividing by the number of teeth.
Missing teeth from the Ramfjord index teeth (16, 21, 24, 36, 41, 44) will not be substituted.
Measured: 21 days and 2 months
Shannon or Simpson Diversity Index
This measure will assess the change in diversity of the microbial community in the sample (alpha diversity). A diversity index provides a mathematical measure that reflects the number of different species (richness) and the evenness of the species' abundances. It ranges from zero to infinity. A higher value means higer diversity.
Measured: 2 months
Bray-Curtis Dissimilarity
It is a distance metrics that measures the beta-diversity. It quantifies the dissimilarity between microbial communitie/ the variation or differences in microbial communities between different samples. It ranges from 0 (identical communities) to 1 (completely different communities).
Measured: 2 months
Biomarker concentrations from gingival cervicular fluid
The concentrations of a panel of biomarkers (IL-1β, TNF-α, IL-6, MMP-8,TIMP-1, TIMP-2) found within the gingival cervicular fluid (GCF) will be assessed with multiplex immunoassays. Unit: ng/mL or as appropriate based on assay's standard.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start20 Nov 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 The University of Hong KongThe 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
- Model description
- randomized double blinded non-inferiority controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Dentaid SL
- Responsible party
- Principal investigator, Dr. Melissa Fok, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967402
- Sponsor's protocol ID
- P&ID2025-01
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is concern that individual participant data sharing may violate data ownership policy of the institute. Information sheet and consent form approved by local IRB did not explicitly permit data sharing beyond the scope of the current study. As such, sharing IPD could potentially infringe upon the rights and expectations of our participants, which we are committed to safeguarding.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Efficacy and Microbiological Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Severe Periodontitis
- ClinicalTrials.gov ID
- NCT06967402
- Acronym / sponsor ID
- P&ID2025-01
- Keywords
- Mouthwash, Chlorhexidine, CPC, Periodontitis, Mouthrinse, cetylpyridinium chloride, Oral antiseptic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Dentaid SL
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 May 2025 (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 focus of this study is on two types of mouthwashes - one containing a chlorhexidine (CHX) at 0.2% (CHX), and the other one containing CHX at a lower concentration of 0.12% with cetylpyridinium chloride (CPC). Both mouthwashes are used to help in the treatment of gum disease. CHX has been known for a long time for its effectiveness against plaque and mouth inflammation. It could inhibit and even kill them. However higher concentrations of CHX comes with unwanted side effect including altered taste, teeth staining and irritation in the mouth. Interestingly, these side effects seem to occur less frequently when a lower concentration CHX solution is used. CPC also combats bacteria by adhering quickly to the surfaces inside your mouth, although it has less substantivity than CHX, it has been shown to reduce plaque and gum inflammation effectively, and it typically causes fewer side effects than CHX. We hypothesize that this new formulation of CHX 0.12%+CPC mouthwash is non-inferior to CHX 0.2% in terms of its anti-plaque and anti-inflammatory properties while presenting with less side effects after 21 days of use. Microbiological samples and fluids from periodontal pockets will be collected before and after treatment for analysis of microbiological effects.
Detailed description
- Aim: To compare the effects of 2 formulations of antiseptics on clinical efficacy (reduction of gingival inflammation and plaque) and oral microbiome when used as an adjuvant in periodontal treatment.
- Hypothesis: HA: The study mouthwash (CLX 0.12% + CPC 0.05%) when used as an adjunct to step 1 periodontal therapy, is non-inferior to control mouthwash (CHX 0.2%) in terms of inflammation and plaque control.
- Primary outcome: Changes in full mouth Bleeding on Probing (BoP) at 2 months after 21 days daily use of test mouthwash as an adjunct to step 1 periodontal therapy compared to active control.
- Secondary outcome:
Changes in BoP at 21 days after baseline. Changes in Löe and Silness Gingival Index at 21 days and 2 months after baseline.
Changes in modified O'Leary plaque index and Turesky modification of Quigley-Hein plaque index at 21 days, 2 months after baseline.
Changes in Tongue Coating Index and Lobene Stain Index at 14, 21 days and 2 months after baseline.
Pocket probing depth (PPD) and clinical attachment level (CAL) changes 2 months after baseline.
Subgingival microbiological changes at 21 days and 2 months after baseline. Gingival cervical fluid volume and inflammatory biomarker profile changes at 21 days and 2 months.
Taste alteration and mucosal irritation at 14 days, 21 days and 2 months after baseline.
Changes in patient-reported outcome measures at 21 days and 2 months after baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blinded non-inferiority controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active control | Active comparator | Other: Control (chlorhexidine with cetylpyridinium chloride)CHX 0.2% |
| Experimental | Experimental | Other: Experimental (chlorhexidine)CHX 0.12%+CPC 0.05% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Consenting patients with at least 6 evaluable teeth in each quadrant, including minimum 1 molar and 1 premolar.
- Generalized stage II-III periodontitis patients.
- Baseline BOP > 25%.
- No known allergy or adverse effects to CHX or CPC
- Non-smokers, non-orthodontic patients, no concurrent or past antibiotics/medication known to affect periodontal status (i.e. calcium antagonists, phenytoin)/anti-inflammatory therapy (i.e. NASIDs) in the last 3 months, pregnant/breastfeeding, compliance to study procedures.
Key exclusion criteria (9 listed)
- Unable to provide written consent.
- Non-compliant study procedures.
- Patients with medical (including psychiatric) and pharmacotherapeutic histories that, in the investigator's opinion, may compromise the protocol.
- Patients requiring antibiotics prophylaxis for dental procedures.
- Patients with self-reported pregnancy or patients who are breastfeeding.
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 |
|---|---|---|
| Experimental (chlorhexidine)Test group: administration of experimental antiseptic (CHX 0.12%+CPC 0.05%) for 3 weeks | Other | Experimental |
| Control (chlorhexidine with cetylpyridinium chloride)Active comparator: administration of control antiseptic (CHX 0.2%) for 3 weeks | Other | Active control |
Primary outcome
% Bleeding on probing (BoP)
Time frame: 2 months
% BoP will be assessed at 6 surfaces (mesiobuccal, mid buccal, disto-buccal, mesio-oral, mid-oral, disto-oral.) in a dichotomous manner (Mühlemann \& Son, 1971). Bleeding will be positive after 15 seconds of probing the gingival sulcus to the most apical stop. The percentage of the full mouth BoP will be reported.
12 secondary outcomes
% Bleeding on probing (BoP)
Time frame: 21 days
Macpherson modification of the Lobene Stain Index (MLSI)
Time frame: 21 days and 2 months
Full mouth plaque score
Time frame: 21 days and 2 months
Clinical attachment level
Time frame: 2 months
Pocket probing depth (PPD)
Time frame: 2 months
Patient-reported outcome measures for mouthwash (PROMs-MW)
Time frame: 14 days, 21 days, 2 months
Oral health impact profile for chronic periodontitis (OHIP-CP)
Time frame: 21 days and 2 months
Löe and Silness Gingival Index
Time frame: 21 days and 2 months
Turesky modification of Quigley-Hein plaque index (TQHPI)
Time frame: 21 days and 2 months
Shannon or Simpson Diversity Index
Time frame: 2 months
Bray-Curtis Dissimilarity
Time frame: 2 months
Biomarker concentrations from gingival cervicular fluid
Time frame: 2 months
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 23 Jun 2026.
- Individual participant dataSharing planned: No. There is concern that individual participant data sharing may violate data ownership policy of the institute. Information sheet and consent form approved by local IRB did not explicitly permit data sharing beyond the scope of the current study. As such, sharing IPD could potentially infringe upon the rights and expectations of our participants, which we are committed to safeguarding.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental (chlorhexidine) in people with Periodontitis and Periodontitis Stage II, run by The University of Hong Kong at 1 site in Hong Kong.
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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 23 Jun 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 Hong Kong. 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?
Contact Melissa Fok, BDS, MDS (Perio), PhD (+85228590495, melfok@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Bleeding on probing (BoP) (time frame: 2 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 23 Jun 2026.