GingivitisNCT06240247
Associations Between Birth Order, Sibship Size and Periodontal Disease
An observational study of Gingivitis, run by Zeynep Tastan Eroglu at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the relationship between sibship size, birth order, gingival health, and oral health habits in systematical healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Gingivitis
- How many people
- 178 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2024to 30 Jun 2024
- How long will I take part?
- 1 Month
- 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 30 years
- All sexes
- Adult
Study population: Patients who came to the Periodontology clinic secretariat for periodontal treatment and who met the inclusion criteria of the study will be included in the study. In order to minimize the effects of aging, the participant age was limited to 18-30. Only people whose parents were still married and who had a maximum of 3 siblings other than themselves were included in the study. It was thought that including participants whose parents were not currently married, whose parents were deceased, who had a half-sibling or who had more than three siblings would increase the confounding variables resulting from divorce or growing up in a family with multiple siblings, so these cases were not included in the study.
Who may be able to join
- Volunteers between the ages of 18-30
- Not having any additional comorbidities
- Having at least 20 teeth in the entire mouth
- Getting diagnosed with healthy gums or Periodontitis
- Having spent his childhood with both parents
- Having at least 1 and at most 3 siblings
Who cannot join
- Being outside the inclusion criteria
- Not agreeing to participate in the study
- Having a psychiatric, mental or physical disability
- Being pregnant and lactating
- Having used any antibiotic, anti-inflammatory or any other drug that may affect - Smoking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Konya/meram
About this study
Official title: Associations Between Birth Order, Sibship Size, Childhood Socioeconomic Factors, Perinatal Characteristics and Oral Health Related Quality of Life and Periodontal Disease
The goal of this observational study is to learn about the relationship between sibship size, birth order, gingival health, and oral health habits in systematical healthy participants. The main questions it aims to answer are:
question 1: Is there any association between birth order and gingival health? question 2: Is there any association between birth order and oral health habits? question 3: Is there any association between birth order, sibship size, childhood socioeconomic factors, perinatal characteristics, and Oral Health-Related Quality of Life and Periodontal Disease? Participants will simply have their routine periodontal examination, fill out the provided questionnaire, and continue their routine periodontal treatment.
Read the detailed description
This study is planned to be carried out with 240 individuals between the ages of 18-30 who applied to Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology for various reasons. In the Department of Periodontology, non-surgical periodontal treatment is performed for every patient diagnosed with periodontal disease after clinical and radiological evaluation.
Individual selection If there are patients who come to the Periodontology clinical secretariat for periodontal treatment and meet the inclusion criteria of the study, patients who agree to fill out the Oral Health Impact Profile-14 (OHIP-14) scales and the sociodemographic questionnaire including the number of siblings, sibling rankings, and other information about birth before the treatment and those who sign the consent form will be included in the study.
This study is actually a prospective survey study. In the study, researchers will ask patients who have undergone routine periodontal examinations by physicians in the clinic and who are planning for treatment to fill out questionnaires beforehand. Survey tracking will continue until the number of people filling out the survey is completed. After filling out the questionnaires, the routine non-surgical periodontal treatments of the patients will be continued.
Routine Periodontal Examination Routine periodontal examination will be used to measure plaque score, gingival score, pocket depths, and attachment loss. The amount of plaque; According to the plaque index (PI) defined by Silness and Löe, 0: no plaque; 1: the presence of plaque coming to the end of the end; 2: the presence of plaque visible; 3: will be considered as excessive plaque accumulation. Gingival index: As defined by Leue and Silness, 0: healthy gingiva; 1: there is slight inflammation and discoloration, there is no bleeding on probing, 2: there is moderate inflammation, hyperemia, bleeding on probing; 3: severe inflammation, hyperemia, ulceration, edema, spontaneous bleeding.
Patients will be diagnosed according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Clinic gingival health would be defined as ≤3 mm probing depth and < 10% bleeding site. Participants will be diagnosed with periodontitis if interdental clinical attachment loss(CAL) is detected in 2 ≥2 adjacent teeth or if more than 3 mm buccal or oral CAL is detected in ≥2 teeth with a probing depth of ≥3 mm. The degree of periodontitis described will be based on the stage and grade system. For the definition of the four stages, the interdental CAL at the site of the greatest loss will be used. Stage classifies the severity and complexity of periodontitis (Stage I-II-III-IV), while grade is used to predict the likelihood of case progression (Grade A, B, C).
Periodontal probing depth and CAL will be evaluated at six sites per tooth. For pocket depth (PD) measurement with a periodontal probe, the probe will be placed 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 edge will be manually recorded at the nearest millimeter mark. Similarly, the CAL will be measured as the distance between the enamel cementum boundary and the bottom of the pocket and recorded manually. When measuring CAL, at points where the enamel cementum boundary is not visible, it will be identified by tactile sense.
Scales to be applied:
Each patient participating in the study will be asked to fill out a questionnaire in which their birth and infancy conditions, childhood sociodemographic status, number and age of siblings, current sociodemographic status, and tooth brushing habits are specified. In addition, they will be asked to fill out the Oral Health Impact Profile-14 (OHIP-14).
When evaluating the age difference with the mother, under the age of 20 will be considered as very young, and 35 and over will be considered as advanced age. The age difference with the father will be stated as 24 and under. The following ranges will be used when assessing birth weight: <2500; 2500-3499; 3400- 3999; ≥4000.
Oral Health Impact Profile-14 (OHIP-14) OHIP-14 scale will be applied to the participants to determine Oral Health Related Quality of Life (OHRQoL). The total score of the responses on the OHIP-14 scale ranged from 0-56. Higher scores indicate a poorer quality of life. Any score higher than 14 will be taken as an indication of poor OHRQoL. The OHIP-14 questionnaire was translated into Turkish and its validity and reliability were made.
Statistical analysis Performed with the G Power program (G * Power 3.1 software; Heinrich Heine University, Düsseldorf, Germany) Correlation: According to the results of the power analysis for the Bivariate Normal Model, it was determined that 200 samples were appropriate when the critical correlation value was 0.3 at 0.90 power (1-β) with α (margin of error) = 0.05. However, assuming that 20% of patients quit, the study is planned to be conducted with a total of 240 people.
The data will be analyzed using the SPSS 11.0 statistical package (SPSS Inc., Chicago, USA). 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 compare more than two groups in terms of quantitative variables. Pearson correlation analysis will be used for the relationship between qualitative variables. A p-value of 0.05 will be considered significant. Logistic regression analyses will be used to assess the roles of sibling size, birth order, and socioeconomic status in tooth loss and periodontal disease risk, and to control for potential confounders.
- Conditions
- Gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gingival healthy | People who do not have clinical attachment loss in their gums, pocket or bone loss, and whose bleeding percentage in their gums is 10% or less | |
| Gingivitis | People who do not have clinical attachment loss in their gums, pocket or bone loss, and whose bleeding percentage in their gums is 10% or more |
What is being measured
The primary outcome is the main question the study is designed to answer.
socio demographic questionnaire and clinical parameters
It will be determined whether there is a relationship between the current periodontal status of the participants and their birth order.
Measured: Through study completion, an average of 4 months
socio demographic and oral oral hygiene habits questionnaire
It will be determined whether there is a relationship between the current oral hygiene habits of the participants and their birth order.
Measured: Through study completion, an average of 4 months
Oral Health Impact Profile-14 (OHIP-14)
It will be determined whether there is a relationship between the current oral health related quality of life of the participants and their birth order. A high score of OHIP-14 indicates low OHRQoL.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start31 Jan 2024
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 178 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Zeynep Tastan Eroglu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Tastan Eroglu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240247
- Sponsor's protocol ID
- BirthOrder
- Status last verified
- Jul 2024
- First submitted
- 22 Jan 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tastan Eroglu Z, Ozkan Sen D, Babayigit O, Yildiz K. Birth order, daycare attendance, and childhood socioeconomic status in relation to gingivitis: a cross-sectional study in Turkish young adults. BMC Oral Health. 2024 Nov 21;24(1):1420. doi: 10.1186/s12903-024-05215-4.
PubMed 39574099
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Birth Order, Sibship Size, Childhood Socioeconomic Factors, Perinatal Characteristics and Oral Health Related Quality of Life and Periodontal Disease
- ClinicalTrials.gov ID
- NCT06240247
- Acronym / sponsor ID
- BirthOrder
- Conditions
- Gingivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Zeynep Tastan ErogluUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the relationship between sibship size, birth order, gingival health, and oral health habits in systematical healthy participants. The main questions it aims to answer are:
question 1: Is there any association between birth order and gingival health? question 2: Is there any association between birth order and oral health habits? question 3: Is there any association between birth order, sibship size, childhood socioeconomic factors, perinatal characteristics, and Oral Health-Related Quality of Life and Periodontal Disease? Participants will simply have their routine periodontal examination, fill out the provided questionnaire, and continue their routine periodontal treatment.
Detailed description
This study is planned to be carried out with 240 individuals between the ages of 18-30 who applied to Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology for various reasons. In the Department of Periodontology, non-surgical periodontal treatment is performed for every patient diagnosed with periodontal disease after clinical and radiological evaluation.
Individual selection If there are patients who come to the Periodontology clinical secretariat for periodontal treatment and meet the inclusion criteria of the study, patients who agree to fill out the Oral Health Impact Profile-14 (OHIP-14) scales and the sociodemographic questionnaire including the number of siblings, sibling rankings, and other information about birth before the treatment and those who sign the consent form will be included in the study.
This study is actually a prospective survey study. In the study, researchers will ask patients who have undergone routine periodontal examinations by physicians in the clinic and who are planning for treatment to fill out questionnaires beforehand. Survey tracking will continue until the number of people filling out the survey is completed. After filling out the questionnaires, the routine non-surgical periodontal treatments of the patients will be continued.
Routine Periodontal Examination Routine periodontal examination will be used to measure plaque score, gingival score, pocket depths, and attachment loss. The amount of plaque; According to the plaque index (PI) defined by Silness and Löe, 0: no plaque; 1: the presence of plaque coming to the end of the end; 2: the presence of plaque visible; 3: will be considered as excessive plaque accumulation. Gingival index: As defined by Leue and Silness, 0: healthy gingiva; 1: there is slight inflammation and discoloration, there is no bleeding on probing, 2: there is moderate inflammation, hyperemia, bleeding on probing; 3: severe inflammation, hyperemia, ulceration, edema, spontaneous bleeding.
Patients will be diagnosed according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Clinic gingival health would be defined as ≤3 mm probing depth and < 10% bleeding site. Participants will be diagnosed with periodontitis if interdental clinical attachment loss(CAL) is detected in 2 ≥2 adjacent teeth or if more than 3 mm buccal or oral CAL is detected in ≥2 teeth with a probing depth of ≥3 mm. The degree of periodontitis described will be based on the stage and grade system. For the definition of the four stages, the interdental CAL at the site of the greatest loss will be used. Stage classifies the severity and complexity of periodontitis (Stage I-II-III-IV), while grade is used to predict the likelihood of case progression (Grade A, B, C).
Periodontal probing depth and CAL will be evaluated at six sites per tooth. For pocket depth (PD) measurement with a periodontal probe, the probe will be placed 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 edge will be manually recorded at the nearest millimeter mark. Similarly, the CAL will be measured as the distance between the enamel cementum boundary and the bottom of the pocket and recorded manually. When measuring CAL, at points where the enamel cementum boundary is not visible, it will be identified by tactile sense.
Scales to be applied:
Each patient participating in the study will be asked to fill out a questionnaire in which their birth and infancy conditions, childhood sociodemographic status, number and age of siblings, current sociodemographic status, and tooth brushing habits are specified. In addition, they will be asked to fill out the Oral Health Impact Profile-14 (OHIP-14).
When evaluating the age difference with the mother, under the age of 20 will be considered as very young, and 35 and over will be considered as advanced age. The age difference with the father will be stated as 24 and under. The following ranges will be used when assessing birth weight: <2500; 2500-3499; 3400- 3999; ≥4000.
Oral Health Impact Profile-14 (OHIP-14) OHIP-14 scale will be applied to the participants to determine Oral Health Related Quality of Life (OHRQoL). The total score of the responses on the OHIP-14 scale ranged from 0-56. Higher scores indicate a poorer quality of life. Any score higher than 14 will be taken as an indication of poor OHRQoL. The OHIP-14 questionnaire was translated into Turkish and its validity and reliability were made.
Statistical analysis Performed with the G Power program (G * Power 3.1 software; Heinrich Heine University, Düsseldorf, Germany) Correlation: According to the results of the power analysis for the Bivariate Normal Model, it was determined that 200 samples were appropriate when the critical correlation value was 0.3 at 0.90 power (1-β) with α (margin of error) = 0.05. However, assuming that 20% of patients quit, the study is planned to be conducted with a total of 240 people.
The data will be analyzed using the SPSS 11.0 statistical package (SPSS Inc., Chicago, USA). 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 compare more than two groups in terms of quantitative variables. Pearson correlation analysis will be used for the relationship between qualitative variables. A p-value of 0.05 will be considered significant. Logistic regression analyses will be used to assess the roles of sibling size, birth order, and socioeconomic status in tooth loss and periodontal disease risk, and to control for potential confounders.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingival healthy | – | –People who do not have clinical attachment loss in their gums, pocket or bone loss, and whose bleeding percentage in their gums is 10% or less |
| Gingivitis | – | –People who do not have clinical attachment loss in their gums, pocket or bone loss, and whose bleeding percentage in their gums is 10% or more |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients who came to the Periodontology clinic secretariat for periodontal treatment and who met the inclusion criteria of the study will be included in the study. In order to minimize the effects of aging, the participant age was limited to 18-30. Only people whose parents were still married and who had a maximum of 3 siblings other than themselves were included in the study. It was thought that including participants whose parents were not currently married, whose parents were deceased, who had a half-sibling or who had more than three siblings would increase the confounding variables resulting from divorce or growing up in a family with multiple siblings, so these cases were not included in the study.
Key inclusion criteria (6 listed)
- Volunteers between the ages of 18-30
- Not having any additional comorbidities
- Having at least 20 teeth in the entire mouth
- Getting diagnosed with healthy gums or Periodontitis
- Having spent his childhood with both parents
Key exclusion criteria (5 listed)
- Being outside the inclusion criteria
- Not agreeing to participate in the study
- Having a psychiatric, mental or physical disability
- Being pregnant and lactating
- Having used any antibiotic, anti-inflammatory or any other drug that may affect - Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
socio demographic questionnaire and clinical parameters
Time frame: Through study completion, an average of 4 months
It will be determined whether there is a relationship between the current periodontal status of the participants and their birth order.
socio demographic and oral oral hygiene habits questionnaire
Time frame: Through study completion, an average of 4 months
It will be determined whether there is a relationship between the current oral hygiene habits of the participants and their birth order.
Oral Health Impact Profile-14 (OHIP-14)
Time frame: Through study completion, an average of 4 months
It will be determined whether there is a relationship between the current oral health related quality of life of the participants and their birth order. A high score of OHIP-14 indicates low OHRQoL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 39574099Tastan Eroglu Z, Ozkan Sen D, Babayigit O, Yildiz K. Birth order, daycare attendance, and childhood socioeconomic status in relation to gingivitis: a cross-sectional study in Turkish young adults. BMC Oral Health. 2024 Nov 21;24(1):1420. doi: 10.1186/s12903-024-05215-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis, run by Zeynep Tastan Eroglu 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
socio demographic questionnaire and clinical parameters (time frame: Through study completion, an average of 4 months). 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 NCT06240247, 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 Jul 2024.