NCT06063460

Brief Summary

The goal of this observational study is to evaluate the effect of non-surgical periodontal treatment on patient halitosis, smell, and taste perception in gingivitis and periodontitis patients. The main questions it aims to answer are:

  • Do gingivitis, periodontitis, and gingival health affect the patient's halitosis, taste, and smell perception?
  • Does non-surgical treatment affect the patient's bad breath, perception of taste and smell? Participants will be informed about the study. No additional intervention will be performed for the study, and patients will continue their routine periodontal treatments.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

October 10, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

September 13, 2023

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Difference between halitosis, smell and taste perception measured by VAS scale in gingival health, gingivitis and periodontitis groups at baseline

    The senses of taste and smell were collected using a visual analogue scale (VAS), where the participants were asked to rate their ability to taste or smell. The value zero represented "no taste" or "no smell," and 100 described "excellent taste" or "excellent smell" . Halitosis was considered the mediator and was measured using a VAS, where the participants were asked to rate their breath odor. The scale went from a value of zero, corresponding to "no bad breath," to 100, corresponding to "extremely bad breath". 3 groups will be compared to each other.

    Baseline

  • Comparison of halitosis taste and smell perception measured by VAS scale in gingivitis and periodontitis groups, at baseline and 1 month after initial treatment

    At the 1st month after the initial treatment, the halitosis, taste and smell perceptions of the participants in all groups will be measured with the VAS scale. The initial and 1st month results of the groups will be compared with each other. The senses of taste and smell were collected using a visual analogue scale (VAS), where the participants were asked to rate their ability to taste or smell. The value zero represented "no taste" or "no smell," and 100 described "excellent taste" or "excellent smell" . Halitosis was considered the mediator and was measured using a VAS, where the participants were asked to rate their breath odor. The scale went from a value of zero, corresponding to "no bad breath," to 100, corresponding to "extremely bad breath".

    1st month

  • Comparison of halitosis taste and smell perception measured by VAS scale in gingivitis and periodontitis groups, at baseline and 3 month after initial treatment

    At the 3rd month after the initial treatment, the halitosis, taste and smell perceptions of the participants in all groups will be measured with the VAS scale. The initial and 1st month results of the groups will be compared with each other. The senses of taste and smell were collected using a visual analogue scale (VAS), where the participants were asked to rate their ability to taste or smell. The value zero represented "no taste" or "no smell," and 100 described "excellent taste" or "excellent smell" . Halitosis was considered the mediator and was measured using a VAS, where the participants were asked to rate their breath odor. The scale went from a value of zero, corresponding to "no bad breath," to 100, corresponding to "extremely bad breath".

    3rd month

Study Arms (3)

Ginigival health

The VAS scale will be filled about halitosis, smell and taste perception by patients diagnosed with gingival health during the exam.Patients will be called for a follow-up check in the 1st and 3rd months. Periodontal examinations will be repeated. The VAS scale will be filled in again with halitosis, smell and taste perception.

Diagnostic Test: Periodontal examinationOther: baseline questionnaire about sociodemographic characteristics, smoking habits, oral hygiene habits, halitosis, smell and taste perceptionOther: 1. month periodontal evaluation and repeat questionnaireOther: 3. month periodontal evaluation and repeat questionnaire

Gingivitis

Patients diagnosed with gingivitis during will have the VAS scale filled in with halitosis, smell and taste perception. Phase 1 treatment will be applied. Patients will be called for a follow-up check in the 1st and 3rd months. Periodontal examinations will be repeated. The VAS scale will be filled in again with halitosis, smell and taste perception.

Diagnostic Test: Periodontal examinationOther: baseline questionnaire about sociodemographic characteristics, smoking habits, oral hygiene habits, halitosis, smell and taste perceptionOther: phase I periodontal treatmentOther: 1. month periodontal evaluation and repeat questionnaireOther: 3. month periodontal evaluation and repeat questionnaire

Periodontitis

Patients diagnosed with periodontitis d will have the VAS scale filled in with halitosis, smell and taste perception. Phase 1 treatment will be applied. Patients will be called for a follow-up check in the 1st and 3rd months. Periodontal examinations will be repeated. The VAS scale will be filled in again with halitosis, smell and taste perception.

Diagnostic Test: Periodontal examinationOther: baseline questionnaire about sociodemographic characteristics, smoking habits, oral hygiene habits, halitosis, smell and taste perceptionOther: phase I periodontal treatmentOther: 1. month periodontal evaluation and repeat questionnaireOther: 3. month periodontal evaluation and repeat questionnaire

Interventions

Periodontal Examination Routine In routine periodontal examination, measurements of plaque score, gingival score, pocket depths, and attachment loss will be utilized.

GingivitisGinigival healthPeriodontitis

Each patient participating in the study will complete a questionnaire detailing their age, gender, height, weight, smoking status, frequency of dental brushing, diabetes status, total annual household income, and Covid-19 history. In addition, a visual analogue scale and self-reported periodontal status questionnaire will be completed. Personal Periodontal Condition Questionnaire This questionnaire comprises of eight questions regarding the participants' periodontal condition. Graphical Analog Scale Patients were asked to rate their perception of taste, smell, and bad breath between 0 and 100 on this scale. Sense of smell (0-I cannot smell at all, 100-I can smell perfectly), sense of taste (0-I cannot taste at all, 100-I can smell perfectly), mouth. The odor will be graded from 0 (no bad breath) to 100 (extremely awful breath).

GingivitisGinigival healthPeriodontitis

Phase I periodontal treatment will be applied by same expert.

GingivitisPeriodontitis

Periodontal examination will be performed in the 1st month, filling the questionnaire about halitosis, smell and taste perception.

GingivitisGinigival healthPeriodontitis

Periodontal examination will be performed in the 3rd month, filling the questionnaire about halitosis, smell and taste perception.

GingivitisGinigival healthPeriodontitis

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will include 216 people aged 18-65 who applied to Necmettin Erbakan University Faculty of Dentistry Department of Periodontology for various reasons. The investigation is scheduled for July-September 2023. After clinical and radiographic evaluation, all periodontal disease patients get phase-1 treatment in the Department of Periodontics. Patients who meet the inclusion criteria and sign the consent form will be included in the study if they fill out sociodemographic information like age, gender, education level, visual analogue scale, and self-reported periodontal status survey before treatment at the Periodontology Clinic Secretariat. The study will diagnose clinically healthy periodontium, gingivitis, and periodontitis.

You may qualify if:

  • Volunteers between the ages of 18-65
  • Healthy periodontium, getting diagnosed with gingivitis or periodontitis

You may not qualify if:

  • Not agreeing to participate in the study
  • Having a psychiatric, mental or physical disability
  • Having received periodontal treatment in the last 6 months
  • Being pregnant and lactating
  • Any antibiotics that may affect periodontal tissues for any reason in the last 6 months
  • Having used an anti-inflammatory or other medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Taştan Eroğlu

Konya, Meram, 42000, Turkey (Türkiye)

Location

Related Publications (1)

  • Tastan Eroglu Z, Kalender ME, Ucan Yarkac F, Babayigit O, Ozkan Sen D. Impact of non-surgical periodontal therapy on self-perceived halitosis, and the senses of smell and taste: a prospective clinical study. BMC Oral Health. 2025 Feb 28;25(1):321. doi: 10.1186/s12903-025-05702-2.

MeSH Terms

Conditions

GingivitisPeriodontitis

Interventions

SmellTaste

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • zeynep taştan eroğlu

    Necmettin Erbakan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 2, 2023

Study Start

October 10, 2023

Primary Completion

November 20, 2023

Study Completion

June 30, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations