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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis; Halitosis; Tongue Condition
• Intervention / Treatment: Other: tongue scraper

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Castro; Phone Number: +3216332407; Email: ana.castro@uzleuven.be
• Study Contact Backup: Name: Jesica Dadamio; Phone Number: +3216332407; Email: jesica.dadamio@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Ana Castro, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: periodontitis; non-surgical treatment; halitosis; tongue cleaning; oral malodor; tongue coating
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Halitosis
• Other Study ID Numbers: S67590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No