## Protocol Section
### Identification Module
**NCT ID:** NCT06430710

**Brief Title:** Tooth Borne Versus Temporary Anchorage Devices (TAD) Based Intrusion Systems for the Correction of Anterior Deep Overbite

**Official Title:** Tooth Borne Versus Temporary Anchorage Devices Based Intrusion Systems for the Correction of Anterior Deep Overbite;Oral Hygiene, Pain and Treatment Effect

#### Organization Study ID Info
**ID:** ORTHO-109-2H
#### Organization
**Class:** OTHER_GOV
**Full Name:** Faculty of Dental Medicine for Girls
### Status Module
#### Completion Date
**Date:** 2024-03-27

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-02-02

**Type:** ACTUAL

#### Start Date
**Date:** 2022-09-25

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Faculty of Dental Medicine for Girls

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Compare the tooth borne versus fixed orthodontic intrusive system (TADs) for the correction of anterior deep overbite

**Detailed Description:** this study determined which method was more compliant, efficacy and comfortable. It was performed to evaluate intrusion of upper incisors with applying tooth borne system as Connecticut Intrusion Arch (CIA) and temporary anchorage devices (TADs) \[miniscrew\] and evaluate the dental and skeletal cephalometric effects of these intrusion methods on individuals with deep bite caused by supraocclusion of upper incisors. It also evaluated oral hygiene and pain sensation in the two groups during the study period.

### Conditions Module

**Conditions:**

- Deep Overbite

**Keywords:**

- Anterior deep bite

- Intrusive arch

- Miniscrews

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Sixteen patients with anterior deep over bite participated in two groups each group contains eight patients

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Miniscrews for incisor intrusion

**Intervention Names:**

- Device: Intrusion

**Label:** Mninscrew

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Continuous arch technique for incisor intrusion

**Intervention Names:**

- Device: Intrusion

**Label:** Intrusive arch

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intrusive arch

- Mninscrew

**Description:** 2 different methods for incisor intrusion

**Name:** Intrusion

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** measure in mm the distance of apical movement

**Measure:** Measure distance of insicors intrusion

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** By unit on Visual Analogue Scale

**Measure:** Pain intensity

**Time Frame:** 8 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Class I or Class II malocclusion with minimal crowding.
2. 70% to 100% overbite.
3. High lip line with gingival display on smiling and super-eruption of maxillary incisors.
4. All patients had permanent dentition with average to vertical growth pattern and curve of Spee of 4mm or less.

Exclusion Criteria:

1. Having missing teeth on the anterior maxillary area.
2. Any history of trauma or root canal treatment.
3. Previous orthodontic treatment.
4. Low lip line duing social smile.
5. Having any hormonal disorder or syndromes.

**Healthy Volunteers:** True

**Maximum Age:** 22 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Al-Azhar University

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008310

- Term: Malocclusion

- 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

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M28896

- Name: Overbite

- Relevance: HIGH

- As Found: Overbite

- ID: M11303

- Name: Malocclusion, Angle Class II

- Relevance: HIGH

- As Found: Overbite

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M11301

- Name: Malocclusion

- 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: D000057887

- Term: Overbite

- ID: D000008312

- Term: Malocclusion, Angle Class II

### Misc Info Module

- Version Holder: 2024-05-31
