## Protocol Section
### Identification Module
**NCT ID:** NCT06416904

**Brief Title:** Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper Versus Mini-Screws

**Official Title:** Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper in Comparison to Mini-Screws in Post-Pubertal Patients: A Randomized Clinical Trial

#### Organization Study ID Info
**ID:** ORTH3-3-3
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-13

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Mennatallah Moamen Mohamed Mohamed Ali

**Investigator Title:** Dentist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study aims to compare the anchorage control during canine retraction using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion

**Detailed Description:** The study begins with patient selection according to inclusion and exclusion criteria, followed by treatment planning, and then bonding of orthodontic brackets of the upper and lower arches, including the second maxillary molars.

After leveling and alignment for all participants, the extraction of the maxillary first premolars will be performed.

* In the "Intervention Group" Canine retraction will be performed on 0.017×0.025 ss archwire with an archwire stopper mesial to the upper first molar.
* In the "Comparator Group" Canine retraction on 0.017×0.025 ss archwire with the upper first molars indirectly anchored to inter-radicular mini screws

Lastly, the anchorage control in both groups and the secondary outcomes will be assessed using the obtained digital models and lateral cephalometric radiographs.

### Conditions Module

**Conditions:**

- Orthodontic Appliance Complication

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 26

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars with archwire stoppers mesial to the maxillary first molars.

**Intervention Names:**

- Device: archwire stopper mesial to the maxillary first molar group

**Label:** arch wire stopper mesial to the maxillary first molar group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw.

**Intervention Names:**

- Device: inter-radicular mini-screw

**Label:** maxillary first molar indirectly anchored to the inter-radicular mini-screw group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- arch wire stopper mesial to the maxillary first molar group

**Description:** canine retraction after the extraction of the maxillary first premolars with archwire stoppers is mesial to the maxillary first molars.

**Name:** archwire stopper mesial to the maxillary first molar group

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- maxillary first molar indirectly anchored to the inter-radicular mini-screw group

**Description:** canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw.

**Name:** inter-radicular mini-screw

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** After full canine retraction, the amount of anchorage loss (mesial movement) of the maxillary first molars of will be assessed on the digital models

**Measure:** Amount of anchorage loss of the maxillary first molars

**Time Frame:** 6 months from the start of the canine retraction

#### Secondary Outcomes

**Description:** the degree of tipping of the maxillary first molars will be assessed on the lateral cephalometric radiograph

**Measure:** Tipping of the maxillary first molar.

**Time Frame:** 6 months from the start of the canine retraction

**Description:** The change in the maxillary incisors inclination will be assessed on the lateral cephalometric radiograph

**Measure:** Maxillary incisors inclination

**Time Frame:** 6 months from the start of the canine retraction

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Post-pubertal female patients.
* Cases with bimaxillary protrusion or Class II Division 1 malocclusion that require maxillary first premolars extraction.
* Full permanent dentition (not necessitating third molars).
* Good oral hygiene.

Exclusion Criteria:

* Medically compromised patients.
* Active periodontal disease or obvious bone loss in the maxillary arch.
* Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
* Smoking or any systemic diseases.
* Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement
* Previous orthodontic treatment.
* Missing teeth.

**Gender Based:** True

**Gender Description:** female patients 15-25 years

**Healthy Volunteers:** True

**Maximum Age:** 25 Years

**Minimum Age:** 15 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mennatallah.moamen@dentistry.cu.edu.eg

**Name:** Mennatallah Ali

**Phone:** 01018509275

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** mennatallah.moamen@dentistry.cu.edu.eg

- **Name:** Mennatallah Moamen, BDS

- **Phone:** +201018509275

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mennatallah Moamen

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Faculty of Dentistry, Cairo University

**Status:** RECRUITING

**Zip:** 12613

#### Overall Officials

**Official 1:**

**Affiliation:** Cairo University

**Name:** Mennatallah Ali

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
