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

NCT ID: NCT06091228

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-06-01

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.

Conditions

Periodontitis; Halitosis; Tongue Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control- No tongue scraping full length of study

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Test 1 - tongue scraping full length of study

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

Group Type: EXPERIMENTAL

tongue scraper

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

tongue scraper

Intervention Type: OTHER

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

Interventions

tongue scraper

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Ana CASTRO SARDA

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Castro

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Central Contacts

Ana Castro

Role: CONTACT

ana.castro@uzleuven.be

+3216332407

Jesica Dadamio

Role: CONTACT

jesica.dadamio@kuleuven.be

+3216332407

Other Identifiers

S67590

Identifier Type: -

Identifier Source: org_study_id