Evaluation of the Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion

NCT ID: NCT04902456

Last Updated: 2021-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-29

Study Completion Date

2022-01-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

There is scarcity in literature regarding the effectiveness of friction and frictionless mechanics during ''En-masse retraction''technique on anchorage loss of posterior segment in orthodontic patients with maxillary protrusion. Moreover there is deficiency in studies measuring the patient pain and satisfaction regarding the different techniques of retraction.

The aim of the current study is to evaluate the effects of friction versus frictionless mechanics, implemented during "En-masse retraction", on anchorage loss. Additionally, assessment of both techniques regarding their rates, effects on root resorption as well as patient satisfaction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

One of the most common complaints of orthodontic patients is proclination of anterior teeth where there is an increase in facial convexity and as well as incompetent lips. Bimaxillary dentoalveolar protrusion and class II division I cases always have this appearance. Frequently this situation requires extraction of the first premolars followed by fixed orthodontic appliance for space closure and retraction of anterior teeth. Different techniques are used including "Two-step retraction" where canines are retracted as a first step followed by anterior four incisors as a second step and "En-masse retraction" where anterior teeth are retracted as one unit. However, the method of "En-masse retraction" is controversial - whether to use frictionless or friction mechanics.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bimaxillary Protrusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Only the outcome assessors will be blind. The patients name will be sealed from pre and post radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Power Chain and Crimpable hook for En-masse retraction

Retraction will start on a 0.017x0.025" Stainless Steel wire using elastomeric chain ( force applied will be 212 g per side ) extending between the crimpable hooks and the miniscrew

Group Type EXPERIMENTAL

Power chain and Crimpable hook fro En-masse Retraction

Intervention Type PROCEDURE

Retraction will start on a 0.017x0.025" stainless steel wire using elastomeric chain ( for applied will be 212 g per side ) extending between the cripmable hooks and the miniscrew

T-loop

Closing retraction T-loops will be fabricated using 0.017x0.025" TMA wire. The loop will be positioned halfway the extraction space and the canine.

Group Type EXPERIMENTAL

T-loop

Intervention Type PROCEDURE

closing retraction T-loops will be fabricated using 0.017x0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Power chain and Crimpable hook fro En-masse Retraction

Retraction will start on a 0.017x0.025" stainless steel wire using elastomeric chain ( for applied will be 212 g per side ) extending between the cripmable hooks and the miniscrew

Intervention Type PROCEDURE

T-loop

closing retraction T-loops will be fabricated using 0.017x0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Orthodontic patients (both genders)
2. Age range (14-24)
3. Patients requiring 1st premolars extraction followed by ''En-masse retraction'' (Bimaxillary Protrusion or Class II division 1 cases).
4. Patients with fully erupted permanent teeth (not necessarily including the 3rd molar).
5. Cases requiring maximum anchorage during anterior segment retraction.
6. Cases with minimal crowding (2-3) mm

Exclusion Criteria

1. Patients suffering from any systemic diseases interfering with tooth movement.
2. Patients with extracted or missing permanent teeth. (except for third molars).
3. Patients with badly decayed teeth.
4. Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc....).
5. Patients with previous orthodontic treatment
Minimum Eligible Age

14 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amr Mahmoud Attia

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yehia Mostafa, Professor and Chairman

Role: STUDY_DIRECTOR

Future University in Egypt

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Amr Attia

Cairo, Future University in Egypt, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FUE.REC (13)/7-2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.