NCT06725654

Brief Summary

Both dental caries prevalence and periodontal status of children residing in children's homes in Sivas province of Turkey were evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

December 2, 2024

Last Update Submit

December 8, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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).

    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.)

    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.)

    Immediately after the orphans filled the survey forms at the first visit

Study Arms (1)

Institutionalized Orphan Children Residing in Children's Homes

Institutionalized orphan children reside in children's homes in Sivas, Turkey.

Other: Diagnostic Procedures

Interventions

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.

Institutionalized Orphan Children Residing in Children's Homes

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Orphaned children aged from 6 to 18 years old residing in children's home who meet the inclusion criteria.

You may qualify if:

  • Does not have any chronic disease.
  • Not taking any medication.
  • To be compatible and healthy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cumhuriyet University

Sivas, Sivas, 58140, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Arzu Koçkanat, Asst.Prof.

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 10, 2024

Study Start

January 5, 2024

Primary Completion

February 12, 2024

Study Completion

February 12, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations