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

Primary Purpose

Periodontitis, Halitosis, Tongue Condition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tongue scraper
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, halitosis, oral malodor, tongue coating, tongue cleaning, non-surgical treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control- No tongue scraping full length of study

    Test 1 - tongue scraping full length of study

    Test 2 - tongue scraping only after non-surgical therapy

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    Improving of halitosis parameters (organoleptic scores)
    reduction in scores

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 13, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06091228
    Brief Title
    The Additional Effect of Tongue Scraping on Halitosis Parameters in Initial Periodontal Therapy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Halitosis, Tongue Condition
    Keywords
    periodontitis, halitosis, oral malodor, tongue coating, tongue cleaning, non-surgical treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    39 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control- No tongue scraping full length of study
    Arm Type
    No Intervention
    Arm Description
    Oral hygiene instructions before and after non-surgical treatment without inclusion of tongue scraper
    Arm Title
    Test 1 - tongue scraping full length of study
    Arm Type
    Experimental
    Arm Description
    Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper
    Arm Title
    Test 2 - tongue scraping only after non-surgical therapy
    Arm Type
    Experimental
    Arm Description
    Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper only after treatment
    Intervention Type
    Other
    Intervention Name(s)
    tongue scraper
    Intervention Description
    tongue cleaning with gentle strokes twice a day covering the whole surface of the tongue
    Primary Outcome Measure Information:
    Title
    Improving of halitosis parameters (organoleptic scores)
    Description
    reduction in scores
    Time Frame
    18 weeks
    Secondary Outcome Measure Information:
    Title
    improving of volatile sulphur compounds
    Description
    reduction in ppb
    Time Frame
    18 weeks
    Title
    improving of periodontal parameters
    Description
    reduction in pocket depth
    Time Frame
    18 weeks
    Title
    improving of oral hygiene parameters.
    Description
    reduction in full mouth bleeding score and full mouth plaque score
    Time Frame
    18 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ana Castro
    Phone
    +3216332407
    Email
    ana.castro@uzleuven.be
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jesica Dadamio
    Phone
    +3216332407
    Email
    jesica.dadamio@kuleuven.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Castro
    Organizational Affiliation
    Universitaire Ziekenhuizen KU Leuven
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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