NCT07326319

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

2 active sites

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 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

December 3, 2025

Last Update Submit

January 2, 2026

Conditions

Keywords

PeriodontitisPeriodontal TreatmentTongue Coating

Outcome Measures

Primary Outcomes (1)

  • 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.

    Time Frame: Baseline (before periodontal treatment) and 3 days after the final treatment session

Secondary Outcomes (1)

  • Change in Tongue Coating Index Score

    Baseline (pre-treatment) and 8 weeks after completion of periodontal treatment

Study Arms (1)

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.

Procedure: Non-Surgical Periodontal Treatment (Scaling and Root Planing

Interventions

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.

Periodontal Treatment Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

batman University Faculty of Dentistry, Department of Periodontology

Batman, Batman City, 72000, Turkey (Türkiye)

Location

batman University Faculty of Dentistry,

Batman, Batman City, 72000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No parties are masked in this study; it is an open-label trial.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 3, 2025

First Posted

January 8, 2026

Study Start

December 1, 2024

Primary Completion

December 3, 2025

Study Completion

December 4, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations