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

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontitis, Halitosis, Tongue Condition

Intervention / Treatment
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* Other: tongue scraper


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving of halitosis parameters (organoleptic scores) | reduction in scores | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improving of volatile sulphur compounds | reduction in ppb | 18 weeks | 
| improving of periodontal parameters | reduction in pocket depth | 18 weeks | 
| improving of oral hygiene parameters. | reduction in full mouth bleeding score and full mouth plaque score | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tongue coating, periodontitis, halitosis, oral malodor, tongue cleaning, non-surgical treatment