Evaluation of Mini Plates Anchorage With Forsus Fatigue Resistant Device

NCT02475785 | Completed

• 1 other identifier: CU001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the Forsus Fatigue resistant Device appliance with direct skeletal mini plates anchorage is capable of achievement of skeletal mandibular effects while preventing the excessive proclination of the lower incisors at the end of the treatment when compared to the conventional Forsus Fatigue resistant Device appliance applied to the upper and lower dental arches in female patients with skeletal Class II malocclusion

Conditions

Malocclusion, Angle Class II, Division 1

Keywords

Forsus Fatigue Resistant Device; Class II; anchorage; FFRD; mini plates; fixed functional appliance

Outcome Measures

Primary Outcomes (1)

• correction of the skeletal Class II profile

  This outcome will be detected through measurement of the mean change in the effective mandibular length and position from baseline data that when increased will result in a decrease in profile convexity. This measurement will be done after FFRD removal and correction of the sagittal relationship. Cone-beam computed tomography (CBCT) images will be used for analysis of this outcome where changes in effective mandibular length (Co-Gn) will be measured in mm

  expected average of 10 months

Secondary Outcomes (3)

• Dento-alveolar side effects

  expected average of 10 months

• Angle of soft tissue convexity

  expected average of 10 months

• Position of lips and Chin

  expected average of 10 months

Study Arms (3)

FFRD and mini plates group

EXPERIMENTAL

Upper will be bonded, levelled and aligned until reaching 0.019 x 0.025 ss archwires. 2 Y shaped mini plates will be inserted in the mandibular symphysis Insertion of the FFRD with Direct application over the mandibular mini plates

Device: FFRD and mini plates group

conventional FFRD

ACTIVE COMPARATOR

Upper and lower arches will be bonded, levelled and aligned until reaching 0.019 x 0.025 ss archwires. Insertion of FFRD with application over the lower archwire

Device: Conventional FFRD

untreated control group

NO INTERVENTION

Patients will be observed for an average duration of 6-8 months

Interventions

FFRD and mini plates group DEVICE

FFRD direct loading over mini plates inserted in the mandibular symphysis

Also known as: Mini plates anchored FFRD

FFRD and mini plates group

Conventional FFRD DEVICE

FFRD inserted between maxillary and mandibular arches with the pushrods placed distal to mandibular canines

Also known as: Dental anchored FFRD

conventional FFRD

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Skeletal Angle Class II division 1 malocclusion with a deficient mandible. (SNB ≤ 76°)
• Horizontal or neutral growth pattern. (MMP ≤ 30°)
• Increased overjet (min 5 mm) with Class II canine relationship. (minimum of half unit)
• Mandibular arch crowding less than 3 mm.
• At the time of insertion of the FFRD, the patients had to be in the "Middle Phalanx of the Middle finger" stage G or H (MP3 G or MP3 H stage) according to Rajagopal.

You may not qualify if:

• Systemic Disease.
• Any signs or symptoms or previous history of temporomandibular disorders (TMD) as clicking, crepitus, pain, limitation or deviation.
• Extracted or missing upper permanent tooth/teeth (except for third molars).
• Facial Asymmetry.
• Para-functional habits.
• Severe proclination or crowding that requires extractions in the lower arch.

Sponsors & Collaborators

• Sherif A. Elkordy: lead

Study Sites (1)

Orthodontic department, Faculty of Oral and Dental Medicine, Cairo University

Cairo, 11553, Egypt

Location

Related Publications (21)

• Pancherz H. Treatment of class II malocclusions by jumping the bite with the Herbst appliance. A cephalometric investigation. Am J Orthod. 1979 Oct;76(4):423-42. doi: 10.1016/0002-9416(79)90227-6.

  PMID: 291343 BACKGROUND

• Pancherz H, Hansen K. Occlusal changes during and after Herbst treatment: a cephalometric investigation. Eur J Orthod. 1986 Nov;8(4):215-28. doi: 10.1093/ejo/8.4.215. No abstract available.

  PMID: 3466794 BACKGROUND

• Sugawara J, Daimaruya T, Umemori M, Nagasaka H, Takahashi I, Kawamura H, Mitani H. Distal movement of mandibular molars in adult patients with the skeletal anchorage system. Am J Orthod Dentofacial Orthop. 2004 Feb;125(2):130-8. doi: 10.1016/j.ajodo.2003.02.003.

  PMID: 14765050 BACKGROUND

• Umemori M, Sugawara J, Mitani H, Nagasaka H, Kawamura H. Skeletal anchorage system for open-bite correction. Am J Orthod Dentofacial Orthop. 1999 Feb;115(2):166-74. doi: 10.1016/S0889-5406(99)70345-8.

  PMID: 9971928 BACKGROUND

• Celikoglu M, Unal T, Bayram M, Candirli C. Treatment of a skeletal Class II malocclusion using fixed functional appliance with miniplate anchorage. Eur J Dent. 2014 Apr;8(2):276-280. doi: 10.4103/1305-7456.130637.

  PMID: 24966783 BACKGROUND

• Unal T, Celikoglu M, Candirli C. Evaluation of the effects of skeletal anchoraged Forsus FRD using miniplates inserted on mandibular symphysis: A new approach for the treatment of Class II malocclusion. Angle Orthod. 2015 May;85(3):413-9. doi: 10.2319/051314-345.1. Epub 2014 Oct 3.

  PMID: 25279724 BACKGROUND

• Elkordy SA, Abouelezz AM, Fayed MM, Attia KH, Ishaq RA, Mostafa YA. Three-dimensional effects of the mini-implant-anchored Forsus Fatigue Resistant Device: A randomized controlled trial. Angle Orthod. 2016 Mar;86(2):292-305. doi: 10.2319/012515-55.1. Epub 2015 May 19.

  PMID: 25989213 BACKGROUND

• Aslan BI, Kucukkaraca E, Turkoz C, Dincer M. Treatment effects of the Forsus Fatigue Resistant Device used with miniscrew anchorage. Angle Orthod. 2014 Jan;84(1):76-87. doi: 10.2319/032613-240.1. Epub 2013 Jun 17.

  PMID: 23772682 BACKGROUND

• Phillips C, Griffin T, Bennett E. Perception of facial attractiveness by patients, peers, and professionals. Int J Adult Orthodon Orthognath Surg. 1995;10(2):127-35.

  PMID: 9081998 BACKGROUND

• Bishara SE, Jakobsen JR. Profile changes in patients treated with and without extractions: assessments by lay people. Am J Orthod Dentofacial Orthop. 1997 Dec;112(6):639-44. doi: 10.1016/s0889-5406(97)70229-4.

  PMID: 9423696 BACKGROUND

• El-Mangoury NH, Mostafa YA. Epidemiologic panorama of dental occlusion. Angle Orthod. 1990 Fall;60(3):207-14. doi: 10.1043/0003-3219(1990)0602.0.CO;2.

  PMID: 2202237 BACKGROUND

• Tulloch JF, Proffit WR, Phillips C. Outcomes in a 2-phase randomized clinical trial of early Class II treatment. Am J Orthod Dentofacial Orthop. 2004 Jun;125(6):657-67. doi: 10.1016/j.ajodo.2004.02.008.

  PMID: 15179390 BACKGROUND

• Koretsi V, Zymperdikas VF, Papageorgiou SN, Papadopoulos MA. Treatment effects of removable functional appliances in patients with Class II malocclusion: a systematic review and meta-analysis. Eur J Orthod. 2015 Aug;37(4):418-34. doi: 10.1093/ejo/cju071. Epub 2014 Nov 13.

  PMID: 25398303 BACKGROUND

• Vogt W. The Forsus Fatigue Resistant Device. J Clin Orthod. 2006 Jun;40(6):368-77; quiz 358. No abstract available.

  PMID: 16804253 BACKGROUND

• Heinig N, Goz G. Clinical application and effects of the Forsus spring. A study of a new Herbst hybrid. J Orofac Orthop. 2001 Nov;62(6):436-50. doi: 10.1007/s00056-001-0053-6. English, German.

  PMID: 11765707 BACKGROUND

• Luzi C, Luzi V, Melsen B. Mini-implants and the efficiency of Herbst treatment: a preliminary study. Prog Orthod. 2013 Jul 31;14:21. doi: 10.1186/2196-1042-14-21.

  PMID: 24325903 BACKGROUND

• Luzi C, Luzi V. [Skeletal Class II treatment with the miniscrew-anchored Herbst]. Orthod Fr. 2013 Dec;84(4):307-18. doi: 10.1051/orthodfr/2013070. Epub 2013 Nov 27. French.

  PMID: 24280546 BACKGROUND

• Cornelis MA, Scheffler NR, Nyssen-Behets C, De Clerck HJ, Tulloch JF. Patients' and orthodontists' perceptions of miniplates used for temporary skeletal anchorage: a prospective study. Am J Orthod Dentofacial Orthop. 2008 Jan;133(1):18-24. doi: 10.1016/j.ajodo.2006.09.049.

  PMID: 18174066 BACKGROUND

• De Clerck H, Cevidanes L, Baccetti T. Dentofacial effects of bone-anchored maxillary protraction: a controlled study of consecutively treated Class III patients. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):577-81. doi: 10.1016/j.ajodo.2009.10.037.

  PMID: 21055597 BACKGROUND

• Kim S, Herring S, Wang IC, Alcalde R, Mak V, Fu I, Huang G. A comparison of miniplates and teeth for orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2008 Feb;133(2):189.e1-9. doi: 10.1016/j.ajodo.2007.07.016.

  PMID: 18249283 BACKGROUND

• Rajagopal R, Kansal S. A comparison of modified MP3 stages and the cervical vertebrae as growth indicators. J Clin Orthod. 2002 Jul;36(7):398-406. No abstract available.

  PMID: 12165981 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sherif Elkordy, Phd

  Associate Lecturer of Orthodontics Cairo University

  PRINCIPAL INVESTIGATOR

• Amr Abouelezz, MSc

  Professor of Orthodontics Cairo University

  STUDY CHAIR

• Mona Fayed, Phd

  Associate Professor of Orthodontics Cairo University

  STUDY DIRECTOR

• Mai Abou el Fotouh, Phd

  Lecturer of Orthodontics Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: June 19, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

EG (1)