Friction Versus Frictionless Mechanics During Maxillary En-masse Retraction in Adult Patients

August 23, 2017 updated by: Sally Magdi Riad, Cairo University

Friction Versus Frictionless Mechanics During Maxillary En-masse Retraction in Adult Patients With Class I Bimaxillary Dentoalveolar Protrusion: A Randomized Clinical Trial

This study is a Randomized clinical trial comparing the effectiveness of two different mechanics during maxillary en-masse retraction in adult patients. Patients will be randomly divided into two groups:Friction and frictionless mechanics. Mini screws will be used in both group to ensure maximum anchorage during retraction. Lateral cephalometric radiographs and dental models will be taken for each patients pre and post -retraction. Following complete anterior segment retraction, the rate and duration of retraction will be evaluated for both groups as well as patient satisfaction with treatment. Changes in incisors inclination and soft tissue as well as anchorage loss will be also assessed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Adult patients with Class I bimaxillary dentoalveolar protrusion will be recruited. All the patients need extraction of upper first premolars followed by anterior segment retraction and maximum anchorage.

The patients will be randomly allocated to one of two groups; either Friction or Frictionless group. In friction group, Nickel Titanium coil spring will be used for retraction of anterior segment while in frictionless group, T-loops will be used for retraction. All the patients will receive two miniscrews , one on each side to achieve maximum anchorage during retraction.

The patients will be seen on a monthly basis for follow up visit for activation of the appliance to maintain constant force during the study. An impression will be taken for the patients every visit, poured into stone for fabrication of dental models. The models will be used to monitor the rate of retraction of anterior teeth.

Every patient will be asked for lateral cephalometric radiograph before and after complete retraction. After data collection, two assessors will carry on the measurements blindly and independently. Statistical analysis of the data will be done and the results will be compared to evaluate the effectiveness of both techniques for en-masse retraction.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female adult patients with age range 18-30 yrs old.
  2. Class I bimaxillary dentoalveolar protrusion .
  3. Full permanent dentition.
  4. Good oral hygiene.
  5. Maximum anchorage is required.
  6. Healthy bone between first molars and second premolars is needed.

Exclusion Criteria:

  1. Systemic disease.
  2. Severe crowding.
  3. Extracted or missing upper permanent tooth/teeth (except for third molars).
  4. Any signs or symptoms or previous history of temporomandibular disorders (TMD).
  5. Previous orthodontic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Friction mechanics

Upper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires.

Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally.

Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. Hook between upper laterals and canines will be fixed on the main archwire.

Nickel Titanium coil spring ( friction mechanics of retraction)will be used for maxillary en-masse retraction by extending the spring from the hook to the molar bands.

Re-activation of the coil spring will be done in the follow up visits to maintain a constant force through the study.
Device: Friction mechanics
Nickel Titanium will be extended from the hook between the lateral incisors and canines to the first molar bands, to allow frictional en-masse retraction of anterior segment.
Other Names:
  • Nickel Titanium coil spring
Active Comparator: Frictionless mechanics

Upper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires.

Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally.

Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. T-loops retraction arch ( frictionless mechanics of retraction)will be used for maxillary en-masse retraction. The wire will be cinched distal to the molar bands.

Re-activation of the retraction loops will be done in the follow up visits to maintain a constant force through the study
Device: Frictionless mechanics
T-loops retraction arch will be placed distal to the upper canines and cinched distal to the first molar bands, to allow frictionless en-masse retraction of anterior segment.
Other Names:
  • T-loops archwire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of retraction
Time Frame: After complete retraction, average 9 months
months through clinical examination of the retracted anterior teeth
After complete retraction, average 9 months
Rate of retraction
Time Frame: Average 9 months, recorded from the begin of retraction till the complete retraction of anterior teeth
millimeters through dental models taken for each patient monthly at the follow up visit
Average 9 months, recorded from the begin of retraction till the complete retraction of anterior teeth
Patient Satisfaction
Time Frame: After complete retraction , average 9 months
Questionnaire will be filled by every patient at the end of the study regarding his experience and acceptance to the treatment, scale from 0 to 5 .
After complete retraction , average 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in incisors inclination
Time Frame: After complete retraction, average 9 months
Degree and millimeter through lateral cephalometric analysis
After complete retraction, average 9 months
Change in soft tissue profile
Time Frame: After complete retraction, average 9 months
Degree and millimeter through lateral cephalometric analysis
After complete retraction, average 9 months
molar anchorage loss
Time Frame: After complete retraction, average 9 months
Degree and millimeter through lateral cephalometric analysis
After complete retraction, average 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Fatma A. Abd El Sayed, Professor, Cairo University
  • Study Director: Fady H. Fahim, lecturer, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Evidence based dentistry EBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Participant information won't be used outside the study except with written permission of the participant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on En-masse Retraction , Class I Bimaxillary Protrusion

Clinical Trials on Friction mechanics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe