Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06063460
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-03
First Post:
2023-09-13
Brief Title:
The Impact of Non-surgical Periodontal Therapy on Patients Halitosis Taste Perception and Smell Sensation
Sponsor:
Necmettin Erbakan University
Organization:
Necmettin Erbakan University
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients halitosis taste and smell perception
Does non-surgical treatment affect the patients 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
Do gingivitis periodontitis and gingival health affect the patients halitosis taste and smell perception
Does non-surgical treatment affect the patients 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
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 studys 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 31 software Heinrich Heine University Düsseldorf Germany with margin of error 005 at a power of 090 1- It was determined that 180 samples were sufficient if the critical correlation value was 03 Nonetheless presuming 20 of patients quit the study is expected to include a total of 216 participants
Using the SPSS 110 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 005 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
Individual preference If patients who seek periodontal treatment at the Periodontology Clinic Secretariat meet the studys 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 31 software Heinrich Heine University Düsseldorf Germany with margin of error 005 at a power of 090 1- It was determined that 180 samples were sufficient if the critical correlation value was 03 Nonetheless presuming 20 of patients quit the study is expected to include a total of 216 participants
Using the SPSS 110 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None