NCT07424300

Brief Summary

This prospective cohort study investigated the relationship between oral malodor and olfactory function in adults with generalized periodontitis. A total of 101 patients were evaluated before and after routine nonsurgical periodontal therapy. Volatile sulfur compound (VSC) levels and psychophysical olfactory performance using the Sniffin' Sticks test (TDI score) were measured at baseline and one week after completion of three sessions of scaling and root planing (SRP). The study aimed to determine whether reduction of oral inflammation and halitosis is associated with improvement in olfactory performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 13, 2026

Last Update Submit

February 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Total TDI Score

    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: * Odor Threshold (1-16). * Odor Discrimination (0-16). * Odor Identification (0-16). Higher scores indicate better olfactory function.

    Baseline to 1 week after completion of third SRP session (approximately 4 weeks total)

  • Change in Total Volatile Sulfur Compound (tVSC) Levels

    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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adults aged 18-55 years diagnosed with generalized periodontitis and presenting with complaints of halitosis who sought care at the Batman University Faculty of Dentistry Clinical Application Center. A total of 150 patients were screened, and 101 individuals who met the inclusion criteria were enrolled in this prospective cohort study.

You may qualify if:

  • Adults aged 18-55 years
  • Diagnosis of generalized periodontitis
  • Complaint of halitosis
  • At least 15 natural teeth

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batman University

Merkez, Batman, 72040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisHalitosis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mustafa Baran, Asst. Prof.

    Batman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 20, 2026

Study Start

December 3, 2024

Primary Completion

March 20, 2025

Study Completion

March 20, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy considerations and institutional data protection policies.

Locations