## Protocol Section
### Identification Module
**NCT ID:** NCT06422611

**Acronym:** Digital

**Brief Title:** Comparing Dental Impression Methods for Children

**Official Title:** Comparison of Traditional and Digital Impression Methods for Pediatric Patients in Terms of Satisfaction

#### Organization Study ID Info
**ID:** Ege U. Ethical Com. 23-4.1/5
#### Organization
**Class:** OTHER
**Full Name:** Ege University
### Status Module
#### Completion Date
**Date:** 2023-08-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-05-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-04-20

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-16
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ege University

#### Responsible Party

**Investigator Affiliation:** Ege University

**Investigator Full Name:** Dilsah Cogulu

**Investigator Title:** Professsor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The precision of dental restorations and the production of dental models has improved due to the acceleration of technical advancement and the introduction of computer-aided manufacturing.

The study's objective is to compare the conventional imprint approach with a digital one in order to compare patients' comfort levels, preferences, and treatment times among pediatric patients.

**Detailed Description:** In this study, 60 volunteers without any prior exposure to traditional or digital impressions took part. Using a C-type impression medium, conventional impressions of the maxillary and mandibular dental arches were taken. Digital impressions are taken using an intra-oral scanner at the same appointment. Following the impressions, a standardized questionnaire was used to assess the individuals' attitudes, preferences, and perceptions of the impression procedures. The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. After taking the impression, the processing phases of the impression techniques (working time, etc.), and parental satisfaction were noted.

### Conditions Module

**Conditions:**

- Dental Impression, Pediatric Dentistry, Satisfaction

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Impression was taken with intraoral scanners

**Intervention Names:**

- Device: Impression methods

**Label:** Digital

#### Arm Group 2

**Description:** Impression was taken with silicone impression material

**Intervention Names:**

- Device: Impression methods

**Label:** Conventional

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Conventional

- Digital

**Description:** Both digital and conventional impressions were taken from same patients

**Name:** Impression methods

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Parental satisfaction was measured with a structured questionnaire.The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. A survey was designed to test 3 areas of patient satisfaction regarding the impression experience: comfort, time, and novelty. The survey consisted of 7 statements with a 100-mm visual analog scale (VAS) below each statement anchored with "agree" and "disagree." The survey also included questions to determine whether the patient had previous experience with impressions.

**Measure:** Assessing patient preference and treatment comfort

**Time Frame:** March 2023-June 2023

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* not to have a history of digital or conventional impression taking
* not to have temporomandibular joint and periodontal discomfort
* not to be using psychiatric or neuropathic drugs

Exclusion Criteria:

* history of digital or conventional impression taking
* TMJ disorder
* Using any kind of drug that interferes pain perception

**Healthy Volunteers:** True

**Maximum Age:** 12 Years

**Minimum Age:** 7 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Patients who needed routine diagnostic records were included in our study.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Izmir

**Country:** Turkey

**Facility:** Ege University

**Zip:** 35040

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
