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GingivitisNCT06063460

The Impact of Non-surgical Periodontal Therapy on Patients' Halitosis, Taste Perception, and Smell Sensation

An observational study of Gingivitis and Periodontitis, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Gingivitis, Periodontitis
What is being tested?
Periodontal examination, baseline questionnaire about sociodemographic characteristics, smoking habits, oral hygiene habits, halitosis, smell and taste perception and phase I periodontal treatment
Type of treatment
Pill or oral medicine
How many people
180 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Oct 2023to 30 Jun 2024
How long will I take part?
3 Months
Phase
Observational
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 18 to 65 years
  • Women only
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Zeynep Taştan Eroğlu

    Konya, Meram, 42000

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of Halitosis, Taste and Smell in Terms of Periodontal Condition Stated by Patients and Periodontal Diagnosis by Dentists, and Then Evaluation of Change Before and After Treatment

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.
Read the detailed description

This research will involve 180 individuals aged 18 to 65 who applied to the Department of Periodontology at the Faculty of Dentistry at Necmettin Erbakan University for various reasons. The investigation is scheduled for September to December of 2023. After clinical and radiological evaluation, each patient diagnosed with periodontal disease in the Department of Periodontics receives initial phase-1 treatment.

Individual preference If patients who seek periodontal treatment at the Periodontology Clinic Secretariat meet the study's inclusion criteria, they will be included in the study if they agree to fill out sociodemographic information such as age, gender, education level, a visual analog scale, and a self-reported periodontal status survey prior to treatment and sign the consent form. In the investigation, participants will be diagnosed with periodontium that is clinically healthy, gingivitis, and periodontitis.

Our research is a prospective survey investigation. In the study, researchers will ask patients undergoing routine periodontal examinations in the clinic and for whom treatment is planned to complete questionnaires beforehand. Tracking of survey responses will continue until the total number of respondents has been reached. Patients will resume their routine phase 1 treatment after completing the questionnaires.

Periodontal Examination Routine In routine periodontal examination, measurements of plaque score, gingival score, pocket depths, and attachment loss will be utilized. Plaque accumulation; According to the PI defined by Silness and Löe, 0: no plaque; 1: plaque at the end of the probe; 2: plaque visible to the naked eye; 3: will be evaluated as excessive plaque accumulation. Gingival index: According to Loe and Silness, 0 indicates healthy gingiva; 1 indicates mild inflammation and discoloration, with no bleeding on probing; 2 indicates moderate inflammation, hyperemia, and bleeding on probing; and 3 indicates severe inflammation, hyperemia, ulceration, edema, and spontaneous bleeding.

Patients will be treated in accordance with the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions. Clinical gingival health will be defined as a probing depth of less than 3 mm and a bleeding area of less than 10%. Periodontitis will be diagnosed if interdental clinical attachment loss (CAL) is detected in 2 nonadjacent teeth or if more than 3 mm of buccal or oral CAL is detected in 2 teeth with a probing depth of 3 mm. The severity of periodontitis will be determined using a system of stages and grades. The interdental CAL at the site of the greatest loss will be used to define the four stages. Stage is used to categorize the severity and complexity of periodontitis (Stage I-II-III-IV), while grade is used to estimate the likelihood of case progression (Grades A and B).

At six sites per tooth, the probing profundity and CAL will be evaluated. For PD measurement with a periodontal probe, the probe is positioned parallel to the vertical axis of the tooth to reach the deepest point of the pocket, and the distance between the base of the pocket and the gingival margin is manually measured to the nearest millimeter mark. Similarly, CAL will be measured and manually recorded as the distance between the cementoenamel border and the bottom of the compartment. When measuring CAL, areas where the enamel-cement border is not visible will be identified through tactile sense.

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 analog scale and self-reported periodontal status questionnaire will be completed.

Personal Periodontal Condition Questionnaire This questionnaire comprises 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).

Statistical examination According to the results of the power analysis for the Correlation: Bivariate Normal Model performed with the G Power program (G * Power 3.1 software; Heinrich Heine University, Düsseldorf, Germany), with (margin of error) = 0.05, at a power of 0.90 (1- It was determined that 180 samples were sufficient if the ) critical correlation value was 0.3. Nonetheless, presuming 20% of patients quit, the study is expected to include a total of 216 participants.

Using the SPSS 11.0 statistical software (SPSS Inc., Chicago, IL, USA), data will be analyzed. The chi-square test will be used to investigate the relationships between qualitative variables, the t-test will be used to compare two groups in terms of quantitative variables, and one-way ANOVA will be used to determine the significance of the relationships. ANOVA will be used to compare quantitative variables between more than two groups. The relationship between qualitative variables will be analyzed using Pearson correlation. A P value of 0.05 will indicate statistical significance. The effects of sibling size, birth order, and socioeconomic status on the risk of tooth loss and periodontal disease will be evaluated and potential confounders will be controlled for using logistic regression analyses.

Being tested
Periodontal examination, baseline questionnaire about sociodemographic characteristics, smoking habits, oral hygiene habits, halitosis, smell and taste perception, phase I periodontal treatment, 1. month periodontal evaluation and repeat questionnaire, 3. month periodontal evaluation and repeat questionnaire
Medical subject headings
Gingivitis, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Periodontal examinationDiagnostic test

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

  • baseline questionnaire about sociodemographic characteristics, smoking habits, oral hygiene habits, halitosis, smell and taste perceptionOther

    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).

  • phase I periodontal treatmentOther

    Phase I periodontal treatment will be applied by same expert.

  • 1. month periodontal evaluation and repeat questionnaireOther

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

  • 3. month periodontal evaluation and repeat questionnaireOther

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

Study groups in NCT06063460
Study groupRoleWhat they receive
Ginigival healthThe 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.
Receives: Diagnostic Test: Periodontal examination; Other: baseline questionnaire about sociodemographic characteristics, smoking habits, oral hygiene habits, halitosis, smell and taste perception; Other: 1. month periodontal evaluation and repeat questionnaire; Other: 3. month periodontal evaluation and repeat questionnaire
GingivitisPatients 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.
Receives: Diagnostic Test: Periodontal examination; Other: baseline questionnaire about sociodemographic characteristics, smoking habits, oral hygiene habits, halitosis, smell and taste perception; Other: phase I periodontal treatment; Other: 1. month periodontal evaluation and repeat questionnaire; Other: 3. month periodontal evaluation and repeat questionnaire
PeriodontitisPatients 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.
Receives: Diagnostic Test: Periodontal examination; Other: baseline questionnaire about sociodemographic characteristics, smoking habits, oral hygiene habits, halitosis, smell and taste perception; Other: phase I periodontal treatment; Other: 1. month periodontal evaluation and repeat questionnaire; Other: 3. month periodontal evaluation and repeat questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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".

    Measured: 1st month

  3. 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".

    Measured: 3rd month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2023
  2. Study start10 Oct 2023
  3. Primary completion20 Nov 2023
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
180 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06063460
Sponsor's protocol ID
PerioSmellTaste
Status last verified
Apr 2024
First submitted
13 Sep 2023
Last updated
3 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40022178

Questions about this trial

What is this clinical trial studying?

An observational study of Gingivitis and Periodontitis, run by Necmettin Erbakan University at 1 site 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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?

Difference between halitosis, smell and taste perception measured by VAS scale in gingival health, gingivitis and periodontitis groups at baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06063460, which also lists 1 linked publication.

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 3 Apr 2024.

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Clinical Trial NCT06063460 | AzTrials