- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424300
Olfactory Function and Oral Malodor in Periodontitis Before and After Periodontal Therapy
Bidirectional Relationship Between Oral Malodor And Olfactory Function In Generalized Periodontitis: A Prospective Cohort Study Evaluating Changes After Nonsurgical Periodontal Therapy
Study Overview
Status
Conditions
Detailed Description
Generalized periodontitis is a chronic inflammatory disease associated with increased production of volatile sulfur compounds (VSCs), contributing to halitosis. Elevated intraoral malodor may interfere with olfactory perception through masking effects and inflammatory mechanisms.
Participants diagnosed with generalized periodontitis and complaining of halitosis underwent routine nonsurgical periodontal therapy consisting of three sessions of scaling and root planing performed at one-week intervals. Olfactory function (threshold, discrimination, identification; total TDI score) and total VSC concentrations were assessed at baseline (prior to first session) and one week after completion of the third session.
The study evaluated changes in chemosensory function and halitosis parameters following periodontal therapy and analyzed correlations between baseline VSC levels and olfactory performance.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Batman
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Merkez, Batman, Turkey (Türkiye), 72040
- Batman University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Inclusion Criteria:
- Adults aged 18-55 years
- Diagnosis of generalized periodontitis
- Complaint of halitosis
- At least 15 natural teeth
Exclusion Criteria:
- Self-reported smell loss or change within 2 weeks prior to baseline
- Antibiotic or anti-inflammatory drug use for more than 7 days within the previous 6 weeks
- Presence of upper respiratory tract infection
- Unrestored advanced dental caries
- History of COVID-19 infection
- Pregnancy
Smoking was not an exclusion criterion.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Generalized Periodontitis Patients With Halitosis
Adults aged 18-55 years diagnosed with generalized periodontitis and presenting with halitosis.
Participants received routine nonsurgical periodontal therapy and were evaluated for olfactory function and volatile sulfur compound levels at baseline and after completion of therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Total TDI Score
Time Frame: Baseline to 1 week after completion of third SRP session (approximately 4 weeks total)
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Change in psychophysical olfactory performance measured by the Sniffin' Sticks Test (Threshold-Discrimination-Identification composite score). The Sniffin' Sticks Test total TDI score ranges from 1 to 48, calculated as the sum of:
Higher scores indicate better olfactory function. |
Baseline to 1 week after completion of third SRP session (approximately 4 weeks total)
|
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Change in Total Volatile Sulfur Compound (tVSC) Levels
Time Frame: Baseline to 1 week after completion of third SRP session
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Change in total volatile sulfur compound (tVSC) concentration measured using the OralChroma portable gas chromatograph device. tVSC levels are reported in parts per billion (ppb). Higher values indicate greater halitosis severity (worse outcome). |
Baseline to 1 week after completion of third SRP session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mustafa Baran, Asst. Prof., Batman University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/08-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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