## Protocol Section
### Identification Module
**NCT ID:** NCT06428474

**Brief Title:** Implementation of Oral Health Educational Program on Orphan Children

**Official Title:** Effectiveness of Oral Health Educational Program on the Knowledge and Practice of Institutionalized Orphan Children in Alexandria, Egypt

#### Organization Study ID Info
**ID:** UREAC-04-3-219
#### Organization
**Class:** OTHER
**Full Name:** Pharos University in Alexandria
### Status Module
#### Completion Date
**Date:** 2024-03-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Pharos University in Alexandria

#### Responsible Party

**Investigator Affiliation:** Pharos University in Alexandria

**Investigator Full Name:** Inas Karawia

**Investigator Title:** Lecturer, Faculty of Dentistry, Pharos University

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Oral diseases are most prevalent among children. Orphans children are one of the most vulnerable groups to diseases especially oral diseases.

Knowledge toward oral cavity and oral hygiene measures is low among this group, leading to poor practice of oral hygiene measures, which outcomes to oral diseases. Implementation of health education program orphan children who are living in orphanages is important. the aim of this study is to evaluate the effectiveness of health education program on the knowledge and practice of orphan children. 80 children were enrolled in this study from different orphanages in Alexandria, Egypt. Knowledge and practice were evaluated before and after intervention using predesigned questionnaire, and oral hygiene was evaluated using simplified oral hygiene index

**Detailed Description:** Background: Dental caries is a lifetime disease, with highest priority risk group between 11-14 years of age group. Environmental factors such as culture, socioeconomic status, life style and dietary pattern can have a greater impact on caries-resistance or development. It has been well-documented in dentistry and other health areas that correct health information or knowledge alone does not necessarily lead to desirable health behaviors. However knowledge gained may serve as a tool to empower population groups with accurate information about health and health care technologies, enabling them to take action to protect their health. According to global review of oral health, despite great improvements in the oral health of populations in several countries, the oral problem persists. This is particularly among underprivileged groups, in both developed and developing countries. One of the known high-risk groups is orphans. An orphan is defined as a child under 18 years, who has lost his father, mother, or both In developing countries like Egypt, there is little access to oral healthcare due to a lack of knowledge, insufficient financial resources, and inadequate dental manpower in the national healthcare system Aim of the study: is to evaluate the effectiveness of oral health education programs on knowledge and practice of participated orphan children Materials and Methods: A specially designed questionnaire was used to assess the dental problems and existing oral hygiene maintenance practice among children between 6 - 12 years of age (n=80) in orphanages. DMFT \[Decayed Missing Filled Teeth index (for permanent teeth)\] and dft \[ decayed filled teeth index ( for primary teeth) \], pre- and post-interventional intra-oral examinations was carried out to check their oral hygiene status which included and OHIS (Simplified Oral Hygiene Index).

Information regarding tooth cleaning habits was obtained by a questionnaire to the children themselves, before, immediately and after 6 months.

Statistical analysis Collected data will be analyzed using SPSS software

### Conditions Module

**Conditions:**

- Dental Caries

- Knowledge

- Practice

**Keywords:**

- Oral health education

- knowledge

- practice

- oral hygiene

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Orphan children aged 6-12

**Intervention Names:**

- Other: Health education

**Label:** children who are living in orphanages

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- children who are living in orphanages

**Description:** Oral health education program designed for orphans children

**Name:** Health education

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The questionnaire consisted of 8 questions to collect data about the children knowledge about teeth number in each dentition, the parts of teeth and its function, causes of oral disease, and how to prevent it.

**Measure:** Knowledge will be assessed using predesigned questionnaire

**Time Frame:** Knowledge was measured immediately and after 6 months

#### Secondary Outcomes

**Description:** practices were measured using a predesigned questionnaire, consisting of 6 questions to collected data about the children's practices regarding tooth brushing, flossing and eating habits.

**Measure:** Practice will be assessed using predesigned questionnaire

**Time Frame:** Practice was evaluated after 6 months

**Description:** Oral hygiene was evaluated using the simplified oral hygiene index - scores were ranged from 0-6 and 6 is the poorest oral hygiene score

**Measure:** oral hygiene

**Time Frame:** oral hygiene was evaluated after 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Orphan children aged between 6-12 years old

Exclusion Criteria:

* children suffering from any systemic diseases acute or chronic, congenital abnormalities, psychological or behavioral problems, or receiving medications

**Maximum Age:** 12 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Alexandria

**Country:** Egypt

**Facility:** Pharos University in Alexandria

**Zip:** 536733

#### Overall Officials

**Official 1:**

**Affiliation:** Pharos University in Alexandria

**Name:** Inas M Karawia

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017001

- Term: Tooth Demineralization

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6928

- Name: Dental Caries

- Relevance: HIGH

- As Found: Dental Caries

- ID: M19339

- Name: Tooth Demineralization

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003731

- Term: Dental Caries

### Misc Info Module

- Version Holder: 2024-05-31
