PeriodontitisEPTOSNCT07326319
Effect of Periodontal Treatment on Tongue Coating and Smell Function
A study testing Non-Surgical Periodontal Treatment (Scaling and Root Planing in people with Periodontitis and Tongue Coating, run by Batman University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of periodontal treatment on olfactory function in patients with periodontitis by comparing pre- and post-treatment periodontal indices, Winkel tongue coating scores, and Sniffin' Sticks TDI components. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis, Tongue Coating, Olfactory Dysfunction
- What is being tested?
- Non-Surgical Periodontal Treatment (Scaling and Root Planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 4 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults with a clinical diagnosis of periodontitis
- At least two teeth with probing pocket depth (PPD) ≥ 5 mm
- Alveolar bone loss visible on full-mouth radiographs
- Non-smokers
- Ability to provide written informed consent
Who cannot join
- Current smokers
- Periodontal treatment within the past 6 months
- Pregnancy or breastfeeding
- Antibiotic use within the past 3 months
- Systemic diseases or conditions known to affect olfactory function
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
batman University Faculty of Dentistry, Department of Periodontology
Batman, Batman City, 72000
batman University Faculty of Dentistry,
Batman, Batman City, 72000
About this study
Official title: The Effect of Periodontal Treatment on Tongue Coating and Olfactory Functions in Patients With Periodontitis
This study aims to investigate the effect of periodontal treatment on olfactory function in patients with periodontitis by comparing pre- and post-treatment periodontal indices, Winkel tongue coating scores, and Sniffin' Sticks TDI components.
Read the detailed description
Periodontitis is a multifactorial chronic inflammatory disease caused by dental plaque, characterized by connective tissue destruction, periodontal pocket formation, and alveolar bone loss. Pathogenic bacteria associated with periodontitis and the host inflammatory response contribute not only to periodontal tissue breakdown but also to oral malodor (halitosis) and disruption of the oral microbiota. Progressive periodontal inflammation promotes the formation of a dense biofilm on the dorsum of the tongue, containing bacterial products, keratinized epithelium, and protein residues. This leads to increased tongue coating, which serves as a primary source of volatile sulfur compounds (VSCs) strongly associated with halitosis.
The Winkel Tongue Coating Index (WTCI) is commonly used to assess tongue coating and is an important clinical indicator for both halitosis and periodontal status. The bacterial load on the tongue also acts as a reservoir, contributing to dysbiosis of the oral microbiota in periodontitis patients.
Recent studies have also highlighted a potential relationship between periodontitis and olfactory function. Proinflammatory cytokines released during periodontal inflammation, such as IL-1β, TNF-α, and IL-6, may negatively affect the olfactory epithelium, leading to impaired odor threshold, discrimination, and identification abilities. Olfactory function is commonly evaluated using the Sniffin' Sticks test, which includes three subtests: odor threshold, odor discrimination, and odor identification. The sum of these tests, known as the TDI score, reflects overall olfactory capacity.
Previous studies have shown that periodontal treatment can improve tongue coating and halitosis. However, studies simultaneously evaluating pre- and post-treatment tongue coating indices, periodontal indices, and olfactory function (TDI scores) are limited. The aim of this study is to compare these parameters before and after periodontal treatment in patients with periodontitis and to investigate the effect of periodontal therapy on olfactory function.
This study was approved by the Batman University Interventional Clinical Research Ethics Committee (Approval No: 2024/08-04). All procedures and data collection were conducted in accordance with the Declaration of Helsinki, and all participants provided written informed consent.
Participant Selection and Exclusion Criteria
A total of 108 non-smoking volunteers with periodontitis were included. Inclusion required the presence of at least two teeth with probing pocket depth (PPD) ≥ 5 mm and alveolar bone loss visible on full-mouth radiographs. Exclusion criteria were: current smokers, participants who received periodontal treatment in the last 6 months, pregnant or breastfeeding women, individuals who had received antibiotics in the last 3 months, or those with systemic conditions potentially affecting olfactory function.
Radiographic Periodontal Assessment
Full-mouth orthopantomographic radiographs were obtained to confirm the periodontal diagnosis and assess alveolar bone status for all participants.
Olfactory Function Assessment
Before periodontal treatment (Phase 1), olfactory function was objectively evaluated in all 108 participants using the Sniffin' Sticks test (Burghart Messtechnik, Holm, Germany). This psychophysical test assesses odor threshold, odor discrimination, and odor identification, each scored on a scale from 0 to 16. The sum of these subtests provided the TDI score, reflecting overall olfactory capacity. A second assessment was performed 3 days after the final periodontal treatment session.
Periodontal Measurements
Clinical periodontal parameters-including Plaque Index (PI), Gingival Bleeding Index (GBI), Probing Pocket Depth (PPD), and Clinical Attachment Loss (CAL)-were recorded for all teeth except third molars using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA). Four sites per tooth (mesial, distal, buccal, lingual) were measured. All measurements were performed by a calibrated periodontist (GGT), and post-treatment measurements were repeated 3 days after the final session. Intra-examiner reliability was assessed using the weighted Kappa test, yielding satisfactory values (e.g., 0.82 for PPD).
Tongue Coating Assessment
Digital photographs of the tongue dorsum were taken at a standardized distance of 60 cm, ensuring patient privacy. Images were analyzed at 1680 × 1050 pixels resolution using Adobe Photoshop. The Winkel Tongue Coating Index (WTCI) was applied, dividing the dorsum into six areas (three anterior, three posterior). Each region was scored as: 0.5 - no coating, 1.5 - mild coating, 2.5 - severe coating. Scores from all six areas were summed (range 0-12) to obtain the final tongue coating score. Two calibrated observers (GGT, VE) independently scored all images, and the average was used as the final score for each participant. Inter-rater reliability and reproducibility were confirmed.
- Conditions
- Periodontitis, Tongue Coating, Olfactory Dysfunction
- Being tested
- Non-Surgical Periodontal Treatment (Scaling and Root Planing
- Keywords
- Periodontitis, Periodontal Treatment, Tongue Coating
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Periodontal Treatment (Scaling and Root PlaningProcedure or surgery
Participants receive standard non-surgical periodontal treatment, including scaling and root planing of all teeth except third molars. Clinical periodontal parameters-including Plaque Index, Gingival Bleeding Index, Probing Pocket Depth, and Clinical Attachment Loss-are recorded before treatment and three days after the final session. Tongue coating is assessed using the Winkel Tongue Coating Index, and olfactory function is evaluated using the Sniffin' Sticks TDI score. Each participant serves as their own control for pre- and post-treatment comparisons.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Treatment Group | Experimental | Participants in this group receive standard non-surgical periodontal treatment, including scaling and root planing. Clinical periodontal parameters (Plaque Index, Gingival Bleeding Index, Probing Pocket Depth, Clinical Attachment Loss), tongue coating (Winkel Tongue Coating Index), and olfactory function (Sniffin' Sticks TDI score) are measured before treatment (baseline) and three days after the final treatment session. Each participant serves as their own control for pre- and post-treatment comparisons. Receives: Procedure: Non-Surgical Periodontal Treatment (Scaling and Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Olfactory Function (TDI Score) Following Periodontal Treatmen
The primary outcome of this study is the change in olfactory function following non-surgical periodontal treatment. Olfactory function is assessed using the Sniffin' Sticks Test Battery, which consists of three subtests: odor threshold, odor discrimination, and odor identification. The sum of these three subtests yields the TDI score, with a total score ranging from 1 to 48. Higher TDI scores indicate better olfactory function.
Measurements are performed at baseline, prior to periodontal treatment, and three days after completion of the final treatment session in order to evaluate short-term changes in olfactory function attributable to periodontal therapy. This pre-post comparison allows each participant to serve as their own control.
Measured: Time Frame: Baseline (before periodontal treatment) and 3 days after the final treatment session
Secondary outcomes (1)
Change in Tongue Coating Index Score
This study evaluates the effects of non-surgical periodontal treatment on tongue coating and olfactory function in patients with periodontitis. A total of 108 non-smoking adults with periodontitis were included. Individuals with recent periodontal treatment, pregnancy or breastfeeding, recent antibiotic use, or systemic conditions affecting olfactory function were excluded.
All participants received scaling and root planing. Periodontal parameters were recorded at baseline and three days after treatment. Tongue coating was assessed using the Winkel Tongue Coating Index, and olfactory function was evaluated using the Sniffin' Sticks Test Battery (TDI score). Pre- and post-treatment measurements were compared, with each participant serving as their own control.
Measured: Baseline (pre-treatment) and 8 weeks after completion of periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Dec 2024
- Primary completion3 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, pre-post interventional study designed to evaluate the effects of non-surgical periodontal treatment on tongue coating and olfactory function in patients with periodontitis. All participants receive the same standardized periodontal therapy, and assessments are conducted before treatment (baseline) and three days after the final treatment session. Clinical periodontal parameters (Plaque Index, Gingival Bleeding Index, Probing Pocket Depth, Clinical Attachment Loss), tongue coating (Winkel Tongue Coating Index), and olfactory function (Sniffin' Sticks TDI score) are measured at both time points. No randomization or blinding is applied, as all participants receive the same intervention, and each patient serves as their own control.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulucag Giray Tekin, Batman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326319
- Sponsor's protocol ID
- BatmanU-PERİO-01-2025
- Acronym
- EPTOS
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared due to ethical and privacy considerations, including protection of participant confidentiality and informed consent restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periodontal Treatment on Tongue Coating and Olfactory Functions in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT07326319
- Acronym / sponsor ID
- EPTOS / BatmanU-PERİO-01-2025
- Conditions
- Periodontitis, Tongue Coating, Olfactory Dysfunction
- Keywords
- Periodontitis, Periodontal Treatment, Tongue Coating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Batman UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of periodontal treatment on olfactory function in patients with periodontitis by comparing pre- and post-treatment periodontal indices, Winkel tongue coating scores, and Sniffin' Sticks TDI components.
Detailed description
Periodontitis is a multifactorial chronic inflammatory disease caused by dental plaque, characterized by connective tissue destruction, periodontal pocket formation, and alveolar bone loss. Pathogenic bacteria associated with periodontitis and the host inflammatory response contribute not only to periodontal tissue breakdown but also to oral malodor (halitosis) and disruption of the oral microbiota. Progressive periodontal inflammation promotes the formation of a dense biofilm on the dorsum of the tongue, containing bacterial products, keratinized epithelium, and protein residues. This leads to increased tongue coating, which serves as a primary source of volatile sulfur compounds (VSCs) strongly associated with halitosis.
The Winkel Tongue Coating Index (WTCI) is commonly used to assess tongue coating and is an important clinical indicator for both halitosis and periodontal status. The bacterial load on the tongue also acts as a reservoir, contributing to dysbiosis of the oral microbiota in periodontitis patients.
Recent studies have also highlighted a potential relationship between periodontitis and olfactory function. Proinflammatory cytokines released during periodontal inflammation, such as IL-1β, TNF-α, and IL-6, may negatively affect the olfactory epithelium, leading to impaired odor threshold, discrimination, and identification abilities. Olfactory function is commonly evaluated using the Sniffin' Sticks test, which includes three subtests: odor threshold, odor discrimination, and odor identification. The sum of these tests, known as the TDI score, reflects overall olfactory capacity.
Previous studies have shown that periodontal treatment can improve tongue coating and halitosis. However, studies simultaneously evaluating pre- and post-treatment tongue coating indices, periodontal indices, and olfactory function (TDI scores) are limited. The aim of this study is to compare these parameters before and after periodontal treatment in patients with periodontitis and to investigate the effect of periodontal therapy on olfactory function.
This study was approved by the Batman University Interventional Clinical Research Ethics Committee (Approval No: 2024/08-04). All procedures and data collection were conducted in accordance with the Declaration of Helsinki, and all participants provided written informed consent.
Participant Selection and Exclusion Criteria
A total of 108 non-smoking volunteers with periodontitis were included. Inclusion required the presence of at least two teeth with probing pocket depth (PPD) ≥ 5 mm and alveolar bone loss visible on full-mouth radiographs. Exclusion criteria were: current smokers, participants who received periodontal treatment in the last 6 months, pregnant or breastfeeding women, individuals who had received antibiotics in the last 3 months, or those with systemic conditions potentially affecting olfactory function.
Radiographic Periodontal Assessment
Full-mouth orthopantomographic radiographs were obtained to confirm the periodontal diagnosis and assess alveolar bone status for all participants.
Olfactory Function Assessment
Before periodontal treatment (Phase 1), olfactory function was objectively evaluated in all 108 participants using the Sniffin' Sticks test (Burghart Messtechnik, Holm, Germany). This psychophysical test assesses odor threshold, odor discrimination, and odor identification, each scored on a scale from 0 to 16. The sum of these subtests provided the TDI score, reflecting overall olfactory capacity. A second assessment was performed 3 days after the final periodontal treatment session.
Periodontal Measurements
Clinical periodontal parameters-including Plaque Index (PI), Gingival Bleeding Index (GBI), Probing Pocket Depth (PPD), and Clinical Attachment Loss (CAL)-were recorded for all teeth except third molars using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA). Four sites per tooth (mesial, distal, buccal, lingual) were measured. All measurements were performed by a calibrated periodontist (GGT), and post-treatment measurements were repeated 3 days after the final session. Intra-examiner reliability was assessed using the weighted Kappa test, yielding satisfactory values (e.g., 0.82 for PPD).
Tongue Coating Assessment
Digital photographs of the tongue dorsum were taken at a standardized distance of 60 cm, ensuring patient privacy. Images were analyzed at 1680 × 1050 pixels resolution using Adobe Photoshop. The Winkel Tongue Coating Index (WTCI) was applied, dividing the dorsum into six areas (three anterior, three posterior). Each region was scored as: 0.5 - no coating, 1.5 - mild coating, 2.5 - severe coating. Scores from all six areas were summed (range 0-12) to obtain the final tongue coating score. Two calibrated observers (GGT, VE) independently scored all images, and the average was used as the final score for each participant. Inter-rater reliability and reproducibility were confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, pre-post interventional study designed to evaluate the effects of non-surgical periodontal treatment on tongue coating and olfactory function in patients with periodontitis. All participants receive the same standardized periodontal therapy, and assessments are conducted before treatment (baseline) and three days after the final treatment session. Clinical periodontal parameters (Plaque Index, Gingival Bleeding Index, Probing Pocket Depth, Clinical Attachment Loss), tongue coating (Winkel Tongue Coating Index), and olfactory function (Sniffin' Sticks TDI score) are measured at both time points. No randomization or blinding is applied, as all participants receive the same intervention, and each patient serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Periodontal Treatment Group | Experimental | Procedure: Non-Surgical Periodontal Treatment (Scaling and Root PlaningParticipants in this group receive standard non-surgical periodontal treatment, including scaling and root planing. Clinical periodontal parameters (Plaque Index, Gingival Bleeding Index, Probing Pocket Depth, Clinical Attachment Loss), tongue coating (Winkel Tongue Coating Index), and olfactory function (Sniffin' Sticks TDI score) are measured before treatment (baseline) and three days after the final treatment session. Each participant serves as their own control for pre- and post-treatment comparisons. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adults with a clinical diagnosis of periodontitis
- At least two teeth with probing pocket depth (PPD) ≥ 5 mm
- Alveolar bone loss visible on full-mouth radiographs
- Non-smokers
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Current smokers
- Periodontal treatment within the past 6 months
- Pregnancy or breastfeeding
- Antibiotic use within the past 3 months
- Systemic diseases or conditions known to affect olfactory function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Surgical Periodontal Treatment (Scaling and Root PlaningParticipants receive standard non-surgical periodontal treatment, including scaling and root planing of all teeth except third molars. Clinical periodontal parameters-including Plaque Index, Gingival Bleeding Index, Probing Pocket Depth, and Clinical Attachment Loss-are recorded before treatment and three days after the final session. Tongue coating is assessed using the Winkel Tongue Coating Index, and olfactory function is evaluated using the Sniffin' Sticks TDI score. Each participant serves as their own control for pre- and post-treatment comparisons. | Procedure or surgery | Periodontal Treatment Group |
Primary outcome
Change in Olfactory Function (TDI Score) Following Periodontal Treatmen
Time frame: Time Frame: Baseline (before periodontal treatment) and 3 days after the final treatment session
The primary outcome of this study is the change in olfactory function following non-surgical periodontal treatment. Olfactory function is assessed using the Sniffin' Sticks Test Battery, which consists of three subtests: odor threshold, odor discrimination, and odor identification. The sum of these three subtests yields the TDI score, with a total score ranging from 1 to 48. Higher TDI scores indicate better olfactory function. Measurements are performed at baseline, prior to periodontal treatment, and three days after completion of the final treatment session in order to evaluate short-term changes in olfactory function attributable to periodontal therapy. This pre-post comparison allows each participant to serve as their own control.
1 secondary outcome
Change in Tongue Coating Index Score
Time frame: Baseline (pre-treatment) and 8 weeks after completion of periodontal treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared due to ethical and privacy considerations, including protection of participant confidentiality and informed consent restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Treatment (Scaling and Root Planing in people with Periodontitis and Tongue Coating, run by Batman University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Olfactory Function (TDI Score) Following Periodontal Treatmen (time frame: Time Frame: Baseline (before periodontal treatment) and 3 days after the final treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.