PeriodontitisNCT06091228
The Additional Effect of Tongue Scraping on Halitosis Parameters in Initial Periodontal Therapy
A study testing tongue scraper in people with Periodontitis and Halitosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Periodontitis can lead to tooth loss which may impair chewing ability and aesthetics. In addition, periodontitis can give rise to halitosis. Standard initial periodontal treatment consists of supra and subgingival biofilm reduction and removal of calculus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Halitosis, Tongue Condition
- What is being tested?
- tongue scraper
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2024to 1 Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Males or females American Society of Anesthesiologist classification I of II,
- 18 years of age or older,
- In good general health as documented by self-assessment
- Suffer from generalised periodontitis (according to 2018 classification)
- Suffer from halitosis with suspected intra-oral cause: organoleptic score (OLS) of 2 or higher by an experienced oral malodour judge
Show all 10Show fewer
- At least one volatile sulphur compounds(VSCs) measurement above the following thresholds:
- Portable sulphur detector (Halimeter) > 107 ppb
- Oral Chroma™: hydrogen sulfide (H₂S) > 112ppb
- Oral Chroma™: methyl mercaptan (CH3SH) >28ppb
Who cannot join
- Participant has a history of chemotherapy or radiotherapy in head and neck area
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Female who is pregnant, breast-feeding or has the intention of becoming pregnant in the following 6 months
- Participation in another interventional Trial with an investigational medicinal product (IMP) or device
- Recent intake of antibiotics (3 months prior to the first consultation)
Show all 15Show fewer
- Antibiotics indicated as part of the periodontal treatment
- Use of antibiotics during the course of the study
- Suffer from halitosis with suspected extra-oral cause
- Suffer from a systemic disease that could cause extra-oral halitosis (e.g. diabetes mellitus, liver or kidney failure, trimethylaminuria)
- Participant has a history of rheumatic fever, neurological deficiencies, or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifedipine, chronic use of non-steroidal anti-inflammatory drugs)
- Presence of active caries lesions
- Unwillingness to return for the follow-up examination
- Wear partial prosthetic dentures removables
- Participant has less than 20 teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven, Campus SintRafael
Leuven
Jesica Dadamio, 0032 473128176, jesica.dadamio@kuleuven.be
Ana B Castro Sarda, DDS, PhD, Prof
About this study
Official title: The Additional Effect of Including Tongue Scraping to the Oral Hygiene Instructions on Halitosis Parameters in Periodontitis Patients Undergoing Standard Initial Periodontal Therapy
Periodontitis can lead to tooth loss which may impair chewing ability and aesthetics. In addition, periodontitis can give rise to halitosis.
Standard initial periodontal treatment consists of supra and subgingival biofilm reduction and removal of calculus. Recently, the European Federation of Periodontology introduced clinical practice guidelines for the treatment of periodontitis. The use of a tongue scraper is not mentioned as element in the standard initial treatment of periodontitis.
The investigators have planned a clinical study in order to provide information about the effect of standard initial periodontal therapy and the additional effect of the use of a tongue scraper as part of the oral hygiene instructions on halitosis parameters in periodontitis patients.
- Conditions
- Periodontitis, Halitosis, Tongue Condition
- Being tested
- tongue scraper
- Keywords
- periodontitis, halitosis, oral malodor, tongue coating, tongue cleaning, non-surgical treatment
- Medical subject headings
- Periodontitis, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tongue scraperOther
tongue cleaning with gentle strokes twice a day covering the whole surface of the tongue
| Study group | Role | What they receive |
|---|---|---|
| Control- No tongue scraping full length of study | No intervention | Oral hygiene instructions before and after non-surgical treatment without inclusion of tongue scraper |
| Test 1 - tongue scraping full length of study | Experimental | Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper Receives: Other: tongue scraper |
| Test 2 - tongue scraping only after non-surgical therapy | Experimental | Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper only after treatment Receives: Other: tongue scraper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving of halitosis parameters (organoleptic scores)
Reduction in organoleptic scores measured in a six point intensity scale proposed by Rosenberg and colleagues. The different scores of this scale are defined as :
- 0: no odour (below the smell threshold)
- 1: barely noticeable odour
- 2: slight odour
- 3: moderate odour
- 4: strong odour
- 5: extremely strong odour, close to saturation
Measured: 18 weeks
Secondary outcomes (3)
Improving of volatile sulphur compounds (VSCs)
Reduction in concentration of VSCs in breath samples measured in ppb by 2 devices (Halimeter, OralChroma CHM-2)
Measured: 18 weeks
improving of periodontal parameters
Reduction in pocket depth (PD) measured by a proving tool in mm (0 to 10)
Measured: 18 weeks
improving of oral hygiene parameters.
reduction in full mouth bleeding score (FMBS) and full mouth plaque score (FMPS) Scores are given as % of measured sites (0 to 100). The higher the number, the worse the oral hygiene.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Sep 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana CASTRO SARDA, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Ana Castro, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091228
- Sponsor's protocol ID
- S67590
- Status last verified
- Feb 2026
- First submitted
- 13 Oct 2023
- Last updated
- 13 Feb 2026
- Results posted
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Additional Effect of Including Tongue Scraping to the Oral Hygiene Instructions on Halitosis Parameters in Periodontitis Patients Undergoing Standard Initial Periodontal Therapy
- ClinicalTrials.gov ID
- NCT06091228
- Acronym / sponsor ID
- S67590
- Conditions
- Periodontitis, Halitosis, Tongue Condition
- Keywords
- periodontitis, halitosis, oral malodor, tongue coating, tongue cleaning, non-surgical treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Oct 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.
Periodontitis can lead to tooth loss which may impair chewing ability and aesthetics. In addition, periodontitis can give rise to halitosis.
Standard initial periodontal treatment consists of supra and subgingival biofilm reduction and removal of calculus. Recently, the European Federation of Periodontology introduced clinical practice guidelines for the treatment of periodontitis. The use of a tongue scraper is not mentioned as element in the standard initial treatment of periodontitis.
The investigators have planned a clinical study in order to provide information about the effect of standard initial periodontal therapy and the additional effect of the use of a tongue scraper as part of the oral hygiene instructions on halitosis parameters in periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control- No tongue scraping full length of study | No intervention | –Oral hygiene instructions before and after non-surgical treatment without inclusion of tongue scraper |
| Test 1 - tongue scraping full length of study | Experimental | Other: tongue scraperOral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper |
| Test 2 - tongue scraping only after non-surgical therapy | Experimental | Other: tongue scraperOral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper only after treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Males or females American Society of Anesthesiologist classification I of II,
- 18 years of age or older,
- In good general health as documented by self-assessment
- Suffer from generalised periodontitis (according to 2018 classification)
Key exclusion criteria (15 listed)
- Participant has a history of chemotherapy or radiotherapy in head and neck area
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Female who is pregnant, breast-feeding or has the intention of becoming pregnant in the following 6 months
- Participation in another interventional Trial with an investigational medicinal product (IMP) or device
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 |
|---|---|---|
| tongue scrapertongue cleaning with gentle strokes twice a day covering the whole surface of the tongue | Other | Test 1 - tongue scraping full length of study, Test 2 - tongue scraping only after non-surgical therapy |
Primary outcome
Improving of halitosis parameters (organoleptic scores)
Time frame: 18 weeks
Reduction in organoleptic scores measured in a six point intensity scale proposed by Rosenberg and colleagues. The different scores of this scale are defined as : * 0: no odour (below the smell threshold) * 1: barely noticeable odour * 2: slight odour * 3: moderate odour * 4: strong odour * 5: extremely strong odour, close to saturation
3 secondary outcomes
Improving of volatile sulphur compounds (VSCs)
Time frame: 18 weeks
improving of periodontal parameters
Time frame: 18 weeks
improving of oral hygiene parameters.
Time frame: 18 weeks
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 13 Feb 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.
Ana Castro principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tongue scraper in people with Periodontitis and Halitosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 10 inclusion and 15 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 13 Feb 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 Belgium. 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 Ana Castro (+3216332407, ana.castro@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving of halitosis parameters (organoleptic scores) (time frame: 18 weeks). 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 13 Feb 2026.