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

En-masse Retraction , Class I Bimaxillary Protrusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03261024
• Other study ID #: Evidence based dentistry EBD
• Status: Not yet recruiting
• Phase: N/A
• First received: August 21, 2017
• Last updated: August 23, 2017
• Start date: November 2017
• Est. completion date: January 2019

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: Fady H. Fahim, Lecturer
• Phone: +20-01006882595
• Email: fady.fahim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• En-masse Retraction , Class I Bimaxillary Protrusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (19)

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Hedayati Z, Shomali M. Maxillary anterior en masse retraction using different antero-posterior position of mini screw: a 3D finite element study. Prog Orthod. 2016 Dec;17(1):31. Epub 2016 Oct 3. — View Citation

Heo W, Nahm DS, Baek SH. En masse retraction and two-step retraction of maxillary anterior teeth in adult Class I women. A comparison of anchorage loss. Angle Orthod. 2007 Nov;77(6):973-8. — View Citation

Jee JH, Ahn HW, Seo KW, Kim SH, Kook YA, Chung KR, Nelson G. En-masse retraction with a preformed nickel-titanium and stainless steel archwire assembly and temporary skeletal anchorage devices without posterior bonding. Korean J Orthod. 2014 Sep;44(5):236-45. doi: 10.4041/kjod.2014.44.5.236. Epub 2014 Sep 25. — View Citation

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Lee D, Heo G, El-Bialy T, Carey JP, Major PW, Romanyk DL. Initial forces experienced by the anterior and posterior teeth during dental-anchored or skeletal-anchored en masse retraction in vitro. Angle Orthod. 2017 Jul;87(4):549-555. doi: 10.2319/080916-616.1. Epub 2016 Nov 10. — View Citation

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. — View Citation

Monga N, Kharbanda OP, Samrit V. Quantitative and qualitative assessment of anchorage loss during en-masse retraction with indirectly loaded miniscrews in patients with bimaxillary protrusion. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):274-82. doi: 10.1016/j.ajodo.2016.02.014. — View Citation

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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. — View Citation

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Upadhyay M, Yadav S, Nagaraj K, Patil S. Treatment effects of mini-implants for en-masse retraction of anterior teeth in bialveolar dental protrusion patients: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):18-29.e1. doi: 10.1016/j.ajodo.2007.03.025. — View Citation

Upadhyay M, Yadav S, Patil S. Mini-implant anchorage for en-masse retraction of maxillary anterior teeth: a clinical cephalometric study. Am J Orthod Dentofacial Orthop. 2008 Dec;134(6):803-10. doi: 10.1016/j.ajodo.2006.10.025. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of retraction	months through clinical examination of the retracted anterior teeth	After complete retraction, average 9 months
Primary	Rate of retraction	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
Primary	Patient Satisfaction	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	Change in incisors inclination	Degree and millimeter through lateral cephalometric analysis	After complete retraction, average 9 months
Secondary	Change in soft tissue profile	Degree and millimeter through lateral cephalometric analysis	After complete retraction, average 9 months
Secondary	molar anchorage loss	Degree and millimeter through lateral cephalometric analysis	After complete retraction, average 9 months