Dental CariesNCT06725654
Evaluation of Oral and Dental Health of Institutionalized Orphan Children Residing in Children's Homes in Turkey
An observational study of Dental Caries and Orphaned Children, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Both dental caries prevalence and periodontal status of children residing in children's homes in Sivas province of Turkey were evaluated. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Orphaned Children, Periodontal Index
- What is being tested?
- Diagnostic Procedures
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2024to 12 Feb 2024
- How long will I take part?
- 1 Day
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Orphaned children aged from 6 to 18 years old residing in children's home who meet the inclusion criteria.
Who may be able to join
- Does not have any chronic disease.
- Not taking any medication.
- To be compatible and healthy.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Both dental caries prevalence and periodontal status of children residing in children's homes in Sivas province of Turkey were evaluated.
Read the detailed description
This study was carried out in 16 state-protected children's homes in Sivas under the Directorate of Coordination of Children's Homes Centres of the Ministry of Family and Social Policies of Turkey. A total of institutionalized 90 orphan children between the ages of 6 and 18, who did not have any chronic diseases, were not taking medication, and were compliant and healthy, were included in the study. Since all participants of this study are under state protection, Sivas Children's Homes Center Coordination Directorate was contacted. The aim of the study and the procedures were explained in detail and official permission was obtained. The children's caregivers signed informed consent forms approved by the Ethics Committee. The examination procedures were performed by two trained dentists as recommended by the WHO. DMFT and deft, GI and PI indices were used to assess dental caries experience, gingival inflammation, and the amount of plaque on the tooth surface, respectively. Also, periodontal status and treatment need were evaluated using the CPITN index.
- Conditions
- Dental Caries, Orphaned Children, Periodontal Index
- Being tested
- Diagnostic Procedures
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic ProceduresOther
To evaluation the oral and dental health of orphaned children, DMFT, deft, GI, PI and CPITN indices were used to assess dental caries experience, gingival inflammation, the amount of plaque on the tooth surface and periodontal status, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Institutionalized Orphan Children Residing in Children's Homes | Institutionalized orphan children reside in children's homes in Sivas, Turkey. Receives: Other: Diagnostic Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries Experience
Oral and dental examination was done by a specialist pedodontist, and DMFT index (total number of decayed, filled, and missing teeth) was recorded.
Measured: Immediately after the orphans filled the survey forms at the first visit
Gingival Index (GI, Löe and Sillness-1963) measurements
In order to determine the gingival inflammation of the participants, the Löe \& Silness gingival index values (GI) were evaluated by a specialist periodontist by scoring the mesial, distal, lingual and vestibular gingival conditions of the teeth (16, 11, 24, 31, 36, 44) determined in each sextant between 0 and 3 (Score 0: healthy gingiva, no inflammation, Score 1: mild inflammation, discoloration and mild edema in the gingiva, no bleeding on probing, Score 2: moderate inflammation, redness and edema in the gingiva, bleeding on probing, Score 3: severe inflammation, redness and edema in the gingiva, spontaneous bleeding).
Measured: Immediately after the orphans filled the survey forms at the first visit
Plaque Index (PI, Sillness and Löe-1964) measurements
In order to determine the amount of plaque on the tooth surface of the participants, Silness \& Löe plaque index values (PI) were evaluated by a specialist periodontist by scoring the mesial, distal, lingual and vestibule gingival conditions of the teeth (16, 11, 24, 31, 36, 44) determined in each sextant between 0 and 3.(Score 0: No bacterial plaque on the tooth surface. Score 1:There is plaque in the form of film and can be seen with the help of a probe. Score 2:There is moderate soft attachment visible to the naked eye. Score 3:There is a visible dense soft appendage filling the gingival sulcus on the tooth surface.)
Measured: Immediately after the orphans filled the survey forms at the first visit
Community Periodontal Index of Treatment Needs (CPITN)
CPI values used to determine the need for community periodontal treatment were determined by a specialist periodontist by scoring between 0 and 4 (Score 0: healthy periodontium, Score 1: bleeding after probing, no calculus/iatrogenic irritation, Score 2: presence of supra and/or subgingival calculus, presence of iatrogenic perforation, Score 3: presence of shallow pockets between 3.5 and 5.5 mm, Score 4: presence of pockets deeper than 5.5 mm). The following scores were used to determine the TN values. (Score 0: No need additional treatment, Score 1: oral hygiene instruction improvement in personal oral hygiene, Score 2: scaling oral hygiene instruction, Score 3: periodontal treatment infected tissue, Score 4: complex periodontal treatment.)
Measured: Immediately after the orphans filled the survey forms at the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start5 Jan 2024
- Primary completion12 Feb 2024
- Study completion12 Feb 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 Dental CariesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Koçkanat, Cumhuriyet University
- Investigators
- Arzu Koçkanat, Asst.Prof., Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725654
- Sponsor's protocol ID
- CumhuriyetU_ArzuKockanat_001
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kockanat A, Acipinar S. Evaluation of oral and dental health of institutionalized orphan children residing in children's homes in Turkiye. BMC Oral Health. 2025 Nov 24;25(1):1829. doi: 10.1186/s12903-025-07240-3.
PubMed 41286857
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral and Dental Health of Institutionalized Orphan Children Residing in Children's Homes in Turkey
- ClinicalTrials.gov ID
- NCT06725654
- Acronym / sponsor ID
- CumhuriyetU_ArzuKockanat_001
- Conditions
- Dental Caries, Orphaned Children, Periodontal Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 10 Dec 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.
Both dental caries prevalence and periodontal status of children residing in children's homes in Sivas province of Turkey were evaluated.
Detailed description
This study was carried out in 16 state-protected children's homes in Sivas under the Directorate of Coordination of Children's Homes Centres of the Ministry of Family and Social Policies of Turkey. A total of institutionalized 90 orphan children between the ages of 6 and 18, who did not have any chronic diseases, were not taking medication, and were compliant and healthy, were included in the study. Since all participants of this study are under state protection, Sivas Children's Homes Center Coordination Directorate was contacted. The aim of the study and the procedures were explained in detail and official permission was obtained. The children's caregivers signed informed consent forms approved by the Ethics Committee. The examination procedures were performed by two trained dentists as recommended by the WHO. DMFT and deft, GI and PI indices were used to assess dental caries experience, gingival inflammation, and the amount of plaque on the tooth surface, respectively. Also, periodontal status and treatment need were evaluated using the CPITN index.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Institutionalized Orphan Children Residing in Children's Homes | – | Other: Diagnostic ProceduresInstitutionalized orphan children reside in children's homes in Sivas, Turkey. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Orphaned children aged from 6 to 18 years old residing in children's home who meet the inclusion criteria.
Key inclusion criteria (3 listed)
- Does not have any chronic disease.
- Not taking any medication.
- To be compatible and healthy.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic ProceduresTo evaluation the oral and dental health of orphaned children, DMFT, deft, GI, PI and CPITN indices were used to assess dental caries experience, gingival inflammation, the amount of plaque on the tooth surface and periodontal status, respectively. | Other | Institutionalized Orphan Children Residing in Children's Homes |
Primary outcome
Caries Experience
Time frame: Immediately after the orphans filled the survey forms at the first visit
Oral and dental examination was done by a specialist pedodontist, and DMFT index (total number of decayed, filled, and missing teeth) was recorded.
Gingival Index (GI, Löe and Sillness-1963) measurements
Time frame: Immediately after the orphans filled the survey forms at the first visit
In order to determine the gingival inflammation of the participants, the Löe \& Silness gingival index values (GI) were evaluated by a specialist periodontist by scoring the mesial, distal, lingual and vestibular gingival conditions of the teeth (16, 11, 24, 31, 36, 44) determined in each sextant between 0 and 3 (Score 0: healthy gingiva, no inflammation, Score 1: mild inflammation, discoloration and mild edema in the gingiva, no bleeding on probing, Score 2: moderate inflammation, redness and edema in the gingiva, bleeding on probing, Score 3: severe inflammation, redness and edema in the gingiva, spontaneous bleeding).
Plaque Index (PI, Sillness and Löe-1964) measurements
Time frame: Immediately after the orphans filled the survey forms at the first visit
In order to determine the amount of plaque on the tooth surface of the participants, Silness \& Löe plaque index values (PI) were evaluated by a specialist periodontist by scoring the mesial, distal, lingual and vestibule gingival conditions of the teeth (16, 11, 24, 31, 36, 44) determined in each sextant between 0 and 3.(Score 0: No bacterial plaque on the tooth surface. Score 1:There is plaque in the form of film and can be seen with the help of a probe. Score 2:There is moderate soft attachment visible to the naked eye. Score 3:There is a visible dense soft appendage filling the gingival sulcus on the tooth surface.)
Community Periodontal Index of Treatment Needs (CPITN)
Time frame: Immediately after the orphans filled the survey forms at the first visit
CPI values used to determine the need for community periodontal treatment were determined by a specialist periodontist by scoring between 0 and 4 (Score 0: healthy periodontium, Score 1: bleeding after probing, no calculus/iatrogenic irritation, Score 2: presence of supra and/or subgingival calculus, presence of iatrogenic perforation, Score 3: presence of shallow pockets between 3.5 and 5.5 mm, Score 4: presence of pockets deeper than 5.5 mm). The following scores were used to determine the TN values. (Score 0: No need additional treatment, Score 1: oral hygiene instruction improvement in personal oral hygiene, Score 2: scaling oral hygiene instruction, Score 3: periodontal treatment infected tissue, Score 4: complex periodontal treatment.)
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 10 Dec 2024.
- Derived from this study: PubMed 41286857Kockanat A, Acipinar S. Evaluation of oral and dental health of institutionalized orphan children residing in children's homes in Turkiye. BMC Oral Health. 2025 Nov 24;25(1):1829. doi: 10.1186/s12903-025-07240-3.
- Individual participant dataSharing planned: No
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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.
Arzu Koçkanat, Asst.Prof. principal investigator
Cumhuriyet University
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 Dental Caries and Orphaned Children, run by Cumhuriyet 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 3 inclusion and 1 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 10 Dec 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?
Caries Experience (time frame: Immediately after the orphans filled the survey forms at the first visit). The study lists 4 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 NCT06725654, 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 10 Dec 2024.