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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a standard treatment for gum disease, known as periodontitis, and whether adding a tongue scraper to the treatment can improve bad breath (halitosis). Periodontitis can cause tooth loss and other issues, and bad breath can be a common problem for those affected. The goal of the study is to see if using a tongue scraper, which is not currently part of standard treatment guidelines, can help reduce bad breath in patients receiving initial periodontal therapy.

To participate in this trial, individuals must be 18 years or older, generally healthy, and diagnosed with generalized periodontitis and bad breath with an oral cause. Participants should be willing to provide consent and attend follow-up appointments. However, certain individuals will not be able to join, such as those with specific health conditions or those who have recently taken antibiotics. This trial is currently not recruiting participants, but it aims to gather valuable information for improving treatments for gum disease and bad breath in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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:
• • 1. Portable sulphur detector \> 107 ppb 26
• • 2. Oral Chroma™: hydrogen sulfide (H₂S) \> 112ppb
• • 3. Oral Chroma™: methyl mercaptan (CH3SH) \>28ppb (as recommended by manufacturer).
• Exclusion Criteria:
• • 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