Periodontitis, Halitosis, Tongue Condition
Conditions
Keywords
periodontitis, halitosis, oral malodor, tongue coating, tongue cleaning, non-surgical treatment
Brief 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. 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
OTHERtongue scraper
tongue cleaning with gentle strokes twice a day covering the whole surface of the tongue
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improving of halitosis parameters (organoleptic scores) | 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
| Measure | Time frame | Description |
|---|---|---|
| Improving of volatile sulphur compounds (VSCs) | 18 weeks | Reduction in concentration of VSCs in breath samples measured in ppb by 2 devices (Halimeter, OralChroma CHM-2) |
| improving of periodontal parameters | 18 weeks | Reduction in pocket depth (PD) measured by a proving tool in mm (0 to 10) |
| improving of oral hygiene parameters. | 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. |
Countries
Belgium
Contacts
CONTACTAna Castro
CONTACTJesica Dadamio
PRINCIPAL_INVESTIGATORAna Castro
Universitaire Ziekenhuizen KU Leuven
Outcome results
None listed