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

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06091228

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

We 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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Halitosis Tongue Condition	Other: tongue scraper	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Additional Effect of Including Tongue Scraping to the Oral Hygiene Instructions on Halitosis Parameters in Periodontitis Patients Undergoing Standard Initial Periodontal Therapy

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control- No tongue scraping full length of study Oral hygiene instructions before and after non-surgical treatment without inclusion of tongue scraper
Experimental: Test 1 - tongue scraping full length of study Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper	Other: tongue scraper tongue cleaning with gentle strokes twice a day covering the whole surface of the tongue
Experimental: Test 2 - tongue scraping only after non-surgical therapy Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper only after treatment	Other: tongue scraper tongue cleaning with gentle strokes twice a day covering the whole surface of the tongue

Arm

Intervention/Treatment

No Intervention: Control- No tongue scraping full length of study

Oral hygiene instructions before and after non-surgical treatment without inclusion of tongue scraper

Experimental: Test 1 - tongue scraping full length of study

Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper

Other: tongue scraper

tongue cleaning with gentle strokes twice a day covering the whole surface of the tongue

Experimental: Test 2 - tongue scraping only after non-surgical therapy

Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper only after treatment

Other: tongue scraper

tongue cleaning with gentle strokes twice a day covering the whole surface of the tongue

Outcome Measures

Primary Outcome Measures

Improving of halitosis parameters (organoleptic scores) [18 weeks]
reduction in scores

Secondary Outcome Measures

improving of volatile sulphur compounds [18 weeks]
reduction in ppb
improving of periodontal parameters [18 weeks]
reduction in pocket depth
improving of oral hygiene parameters. [18 weeks]
reduction in full mouth bleeding score and full mouth plaque score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Portable sulphur detector > 107 ppb 26
Oral Chroma™: hydrogen sulfide (H₂S) > 112ppb
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

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