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New treatment option for Periodontitis
Official title The Additional Effect of Tongue Scraping on Halitosis Parameters in Initial Periodontal Therapy
ClinicalTrials.gov ID: NCT06091228
What this study is testing
- What it's testing
- Periodontitis can lead to tooth loss which may impair chewing ability and aesthetics. In addition, periodontitis can give rise to halitosis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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 treatment Trial with an investigational medicinal product (IMP) or device
- Recent intake of antibiotics (3 months prior to the first consultation)
See the full eligibility 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
- 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 treatment 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...
- Presence of active caries lesions
- Unwillingness to return for the follow-up examination
- Wear partial prosthetic dentures removables
- Participant has less than 20 teeth
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.