## Protocol Section
### Identification Module
**NCT ID:** NCT06416189

**Brief Title:** Teeth Decrowding With and Without Fixed Appliances

**Official Title:** The Decrowding Rate Post Premolar Extraction With and Without Fixed Appliance: Randomized Controlled Trial

#### Organization Study ID Info
**ID:** Ortho-0001
#### Organization
**Class:** OTHER
**Full Name:** Samer Mheissen
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-26
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Samer Mheissen

#### Responsible Party

**Investigator Affiliation:** Samer Mheissen

**Investigator Full Name:** Samer Mheissen

**Investigator Title:** Researcher

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** In orthodontics, the teeth tend to move to the extraction space. This tooth movement becomes of larger importance when there is a crowding. During the COVID lockdown period, It was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation.

**Detailed Description:** In this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces.

### Conditions Module

**Conditions:**

- Tooth Crowding

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Two groups; one with fixed braces and one without fixed braces.

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** The two groups will have lingual arches. However, patients without braces will not be informed about their braces before 5 months of trial initiation.

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Fixed appliance would be bonded post teeth extraction (premolars). subsequently, leveling and alignment using sequence of archwires would be followed. The measurements would be done using models each month.

**Intervention Names:**

- Device: Fixed appliances

**Label:** Braces

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Extraction of premolars and only observing the case over time. The measurements would be done using models each month.

**Label:** Without braces

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Braces

**Description:** MBT Brackets 0.022 inch

**Name:** Fixed appliances

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The cumulative before extraction and space closure for 4 months (mean difference before and after)..

**Measure:** Anterior teeth alignment every 4 weeks at each time point.

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** The anchorage loss of molars will be measured over time using the models.

**Measure:** Molar anchorage loss at each time point.

**Time Frame:** 6 months

**Description:** this will be measured by visual inspection intraorally.

**Measure:** Gingival invagination

**Time Frame:** 9 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

- Patients with permanent dentition between age group of 13 - 30 years.

* Maxillary or mandibular crowding \>4.1mm and requiring extraction of maxillary first premolars or mandibular first premolars. The crowding will be measured using a caliper one cast models.
* Fully erupted teeth from 1st molar to the 1st molar.
* Patients with periodontally sound dentition.
* Patients with good general health. No previous history of extraction or orthodontic tooth movement.

Exclusion Criteria:

* Cases requiring orthognathic surgery.

  * History of systemic and medical illness.
  * Contraindication of extraction.
  * Previous history of orthodontic treatment.
  * Poor oral hygiene.
  * Nickel allergy.

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 13 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mheissen@yahoo.com

**Name:** Samer Mheissen, orthodontics

**Phone:** 00962795710426

**Role:** CONTACT

**Contact 2:**

**Email:** drhariskhan@gmail.com

**Name:** Haris Khan, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Amman

**Contacts:**

***Contact 1:***

- **Email:** hna987@hotmail.com

- **Name:** Hanan Habarneh, DDS

- **Phone:** +962 7 7233 6009

- **Role:** CONTACT

**Country:** Jordan

**Facility:** Medical Services

**Status:** RECRUITING

**Zip:** 00962

#### Overall Officials

**Official 1:**

**Affiliation:** Private Practice

**Name:** Samer Mheissen, DDS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** 12 months

## Derived Section

### Condition Browse Module - Ancestors

- 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: M11301

- Name: Malocclusion

- Relevance: HIGH

- As Found: Tooth Crowding

- 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: D000008310

- Term: Malocclusion

### Misc Info Module

- Version Holder: 2024-05-31
