Adding tongue scraping to initial periodontal therapy to reduce bad breath
The Additional Effect of Including Tongue Scraping to the Oral Hygiene Instructions on Halitosis Parameters in Periodontitis Patients Undergoing Standard Initial Periodontal Therapy
This will see if adding daily tongue scraping to standard initial periodontal treatment reduces bad breath in adults with generalized periodontitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06091228 on ClinicalTrials.gov |
What this trial studies
Adults with generalized periodontitis and intra-oral halitosis will receive standard initial periodontal therapy (supra- and subgingival biofilm reduction and calculus removal) and be instructed on oral hygiene with or without a tongue scraper. Halitosis will be measured by organoleptic scoring and volatile sulfur compound measurements using a Halimeter and Oral Chroma. The study compares halitosis parameters before and after treatment to determine any additional benefit from tongue scraping. Participants are recruited and treated at UZ Leuven, Campus Sint-Rafael.
Who should consider this trial
Good fit: Adults (≥18 years) in good general health with generalized periodontitis and intra-oral halitosis (organoleptic score ≥2 and elevated VSCs) who can give informed consent are ideal candidates.
Not a fit: Patients whose bad breath originates from non-oral causes, those without elevated VSC measurements or organoleptic scores, or those with a history of head/neck radiotherapy are unlikely to benefit.
Why it matters
Potential benefit: If successful, adding tongue scraping could provide an easy, low-cost way to reduce bad breath and improve oral hygiene for patients with periodontitis.
How similar studies have performed: Previous small trials have shown tongue cleaning can reduce oral malodor in the short term, but its added benefit specifically alongside initial periodontal therapy is not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * At least one volatile sulphur compounds(VSCs) measurement above the following thresholds: 1. Portable sulphur detector (Halimeter) \> 107 ppb 2. Oral Chroma™: hydrogen sulfide (H₂S) \> 112ppb 3. Oral Chroma™: methyl mercaptan (CH3SH) \>28ppb Exclusion Criteria: * 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) * 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
Where this trial is running
Leuven
- UZLeuven, Campus SintRafael — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Ana Castro — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Ana Castro
- Email: ana.castro@uzleuven.be
- Phone: +3216332407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.