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

NCT06091228 | Recruiting

• 1 other identifier: S67590
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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. The investigators 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

Keywords

periodontitis; halitosis; oral malodor; tongue coating; tongue cleaning; non-surgical treatment

Outcome Measures

Primary Outcomes (1)

• Improving of halitosis parameters (organoleptic scores)

  Reduction in organoleptic scores measured in a six point intensity scale proposed by Rosenberg and colleagues. The different scores of this scale are defined as : * 0: no odour (below the smell threshold) * 1: barely noticeable odour * 2: slight odour * 3: moderate odour * 4: strong odour * 5: extremely strong odour, close to saturation

  18 weeks

Secondary Outcomes (3)

• Improving of volatile sulphur compounds (VSCs)

  18 weeks

• improving of periodontal parameters

  18 weeks

• improving of oral hygiene parameters.

  18 weeks

Study Arms (3)

Control- No tongue scraping full length of study

NO INTERVENTION

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

Test 1 - tongue scraping full length of study

EXPERIMENTAL

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

Other: tongue scraper

Test 2 - tongue scraping only after non-surgical therapy

EXPERIMENTAL

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

Other: tongue scraper

Interventions

tongue scraper OTHER

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

Test 1 - tongue scraping full length of study; Test 2 - tongue scraping only after non-surgical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Males or females American Society of Anesthesiologist classification I of II,
• years of age or older,
• In good general health as documented by self-assessment
• Suffer from generalised periodontitis (according to 2018 classification)
• Suffer from halitosis with suspected intra-oral cause: organoleptic score (OLS) of 2 or higher by an experienced oral malodour judge
• At least one volatile sulphur compounds(VSCs) measurement above the following thresholds:
• Portable sulphur detector (Halimeter) \> 107 ppb
• Oral Chroma™: hydrogen sulfide (H₂S) \> 112ppb
• Oral Chroma™: methyl mercaptan (CH3SH) \>28ppb

You may not qualify if:

• Participant has a history of chemotherapy or radiotherapy in head and neck area
• Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
• Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
• Female who is pregnant, breast-feeding or has the intention of becoming pregnant in the following 6 months
• Participation in another interventional Trial with an investigational medicinal product (IMP) or device
• Recent intake of antibiotics (3 months prior to the first consultation)
• Antibiotics indicated as part of the periodontal treatment
• Use of antibiotics during the course of the study
• Suffer from halitosis with suspected extra-oral cause
• Suffer from a systemic disease that could cause extra-oral halitosis (e.g. diabetes mellitus, liver or kidney failure, trimethylaminuria)
• 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)
• Presence of active caries lesions
• Unwillingness to return for the follow-up examination
• Wear partial prosthetic dentures removables
• Participant has less than 20 teeth

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven, Campus SintRafael

Leuven, Belgium

RECRUITING

MeSH Terms

Conditions

Periodontitis; Halitosis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Castro

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Castro

CONTACT

+3216332407; ana.castro@uzleuven.be

Jesica Dadamio

CONTACT

+3216332407; jesica.dadamio@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)