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NCT Number: NCT06091228

The Additional Effect of Tongue Scraping on Halitosis Parameters in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZLeuven, Campus SintRafael

Leuven, Belgium

Location status: Recruiting

Location contact

Ana B Castro Sarda, DDS, PhD, Prof

PRINCIPAL_INVESTIGATOR

Jesica Dadamio

CONTACT

[email protected]

0032 473128176

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tongue scraper

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Improving of volatile sulphur compounds (VSCs)

    Time frame: 18 weeks

    Reduction in concentration of VSCs in breath samples measured in ppb by 2 devices (Halimeter, OralChroma CHM-2)

  2. improving of periodontal parameters

    Time frame: 18 weeks

    Reduction in pocket depth (PD) measured by a proving tool in mm (0 to 10)

  3. improving of oral hygiene parameters.

    Time frame: 18 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Castro

CONTACT

[email protected]

+3216332407

Jesica Dadamio

CONTACT

[email protected]

+3216332407

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

The Additional Effect of Including Tongue Scraping to the Oral Hygiene Instructions on Halitosis Parameters in Periodontitis Patients Undergoing Standard Initial Periodontal Therapy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2023
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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