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

NCT ID: NCT03261024

Last Updated: 2017-08-24

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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En-masse Retraction , Class I Bimaxillary Protrusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Friction mechanics

Intervention Type DEVICE

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.

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

Group Type ACTIVE_COMPARATOR

Frictionless mechanics

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Nickel Titanium coil spring T-loops archwire

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sally Magdi Riad

Assistant lecturer- Orthodontic department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma A. Abd El Sayed, Professor

Role: STUDY_CHAIR

Cairo University

Fady H. Fahim, lecturer

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Fady H. Fahim, Lecturer

Role: CONTACT

+20-01006882595

Fatma A. Abd El Sayed, Professor

Role: CONTACT

+20-01005275779

References

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Park HS, Yoon DY, Park CS, Jeoung SH. Treatment effects and anchorage potential of sliding mechanics with titanium screws compared with the Tweed-Merrifield technique. Am J Orthod Dentofacial Orthop. 2008 Apr;133(4):593-600. doi: 10.1016/j.ajodo.2006.02.041.

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Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.

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Lee J, Miyazawa K, Tabuchi M, Sato T, Kawaguchi M, Goto S. Effectiveness of en-masse retraction using midpalatal miniscrews and a modified transpalatal arch: Treatment duration and dentoskeletal changes. Korean J Orthod. 2014 Mar;44(2):88-95. doi: 10.4041/kjod.2014.44.2.88. Epub 2014 Mar 19.

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Ziegler P, Ingervall B. A clinical study of maxillary canine retraction with a retraction spring and with sliding mechanics. Am J Orthod Dentofacial Orthop. 1989 Feb;95(2):99-106. doi: 10.1016/0889-5406(89)90388-0.

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Magdi S, Abdelsayed FA, Aboulfotouh MH, Fahim FH. Friction versus frictionless mechanics during maxillary en-masse retraction in adult patients with Class I bimaxillary dentoalveolar protrusion: a randomized clinical trial. Eur J Orthod. 2024 Aug 1;46(4):cjae034. doi: 10.1093/ejo/cjae034.

Reference Type DERIVED
PMID: 39011819 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Evidence based dentistry EBD

Identifier Type: -

Identifier Source: org_study_id

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