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Recruiting NCT06091228

The Additional Effect of Tongue Scraping on Halitosis Parameters in Initial Periodontal Therapy

No phase Interventional Periodontitis Halitosis Tongue Condition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tongue scraper.
Who it may be relevant to
Registry conditions: Periodontitis, Halitosis, Tongue Condition. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other tongue scraper
    tongue cleaning with gentle strokes twice a day covering the whole surface of the tongue

Primary outcome measures

  • Improving of halitosis parameters (organoleptic scores) [Time frame: 18 weeks]
Secondary outcome measures (3)
  • 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]

Eligibility 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:
  • Portable sulphur detector (Halimeter) > 107 ppb
  • Oral Chroma™: hydrogen sulfide (H₂S) > 112ppb
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • UZLeuven, Campus SintRafael — Leuven

Identifiers

NCT: NCT06091228 · S67590

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗