💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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