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

ConditionsPeriodontitisHalitosisTongue Condition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • tongue scraper

    Other intervention

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

Treatment groups

39 Participants
are divided into 3 treatment groups
Group A: Control- No tongue scraping full length of studyNo intervention 0 interventions
Group B: Test 1 - tongue scraping full length of studyExperimental treatment 1 intervention
Group C: Test 2 - tongue scraping only after non-surgical therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
18 weeks

Secondary outcomes

1

Improving of volatile sulphur compounds (VSCs)

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

Time frame
18 weeks
2

improving of periodontal parameters

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

Time frame
18 weeks
3

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.

Time frame
18 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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