Status:
UNKNOWN
The Additional Effect of Tongue Scraping on Halitosis Parameters in Initial Periodontal Therapy
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Periodontitis
Halitosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 1\. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Males or females American Society of Anesthesiologist classification I of II, 3. 18 years of age or older, 4. In good general health as documented by self-assessment 5. Suffer from generalised periodontitis (according to 2018 classification) 4 6. Suffer from halitosis with suspected intra-oral cause: organoleptic score of 2 or higher by an experienced oral malodour judge 7. At least one volatile sulphur compounds measurement above the following thresholds:
- Portable sulphur detector \> 107 ppb 26
- Oral Chroma™: hydrogen sulfide (H₂S) \> 112ppb
- Oral Chroma™: methyl mercaptan (CH3SH) \>28ppb (as recommended by manufacturer).
Exclusion
- 1\. Participant has a history of chemotherapy or radiotherapy in head and neck area 2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial 4. Female who is pregnant, breast-feeding or has the intention of becoming pregnant in the following 6 months 5. Participation in another interventional Trial with an investigational medicinal product (IMP) or device 6. Recent intake of antibiotics (3 months prior to the first consultation) 7. Antibiotics indicated as part of the periodontal treatment 8. Use of antibiotics during the course of the study 9. Suffer from halitosis with suspected extra-oral cause 10. Suffer from a systemic disease that could cause extra-oral halitosis (e.g. diabetes mellitus, liver or kidney failure, trimethylaminuria) 11. 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) 12. Presence of active caries lesions 13. Unwillingness to return for the follow-up examination 14. Wear partial prosthetic dentures removables 15. Participant has less than 20 teeth
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06091228
Start Date
January 1 2024
End Date
June 1 2025
Last Update
October 19 2023
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