Anchorage Reinforcement in Bimaxillary Proclination Cases

NCT04705545 | Active Not Recruiting

• 1 other identifier: UM_ORTHO_KM001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Bimaxillary protrusion are common in Malaysia due to the prevalence in the two biggest races (Malay and Chinese). However, evidence for treatment methods and outcomes for bimaxillary protrusion patients are scarce. The need for high anchorage in bimaxillary protrusion cases also makes them perfect candidates for a study on the effectiveness of different anchorage methods commonly used in treatment of bimaxillary protrusion cases. The soft tissue outcomes from the use of these different methods are also our area of interest. Hence, the investigators aim is to prove that molar block anchorage similarly effective and has the same outcome as using other conventional auxiliary anchorage such as TPA and Nance button in treating patients with bimaxillary protrusion.

Conditions

Bimaxillary Proclination

Keywords

bimaxillary proclination; anchorage; soft tissue changes

Outcome Measures

Primary Outcomes (3)

• molar movement

  Three plane movement of the maxillary permanent first molar in terms of anchorage loss (in mm)

  24 months

• Soft tissue cephalometric changes (angle)

  Nasolabial angle, H angle and facial convexity angle

  24 months

• Soft tissue cephalometric changes (degrees)

  E line, labiomental sulcus depth, upper lip length, lip protuberance

  24 months

Secondary Outcomes (3)

• Duration of treatment visits (minutes)

  24 months

• Number of treatment visits (days)

  24 months

• Hard tissue cephalometric changes (degrees)

  24 months

Study Arms (3)

molar block

NO INTERVENTION

No additional anchorage reinforcements besides the banding first and second molar with and tying them together at the buccal tubes (also known as molar block)

TPA group

EXPERIMENTAL

Bands are selected and an alginate impression taken over the bands. The impression will be sent to the lab for the construction of a transpalatal archwire on a 1.0 mm stainless steel wire connecting the upper permanent first molar, with a U loop pointing posteriorly, soldered to the palatal side of the molar bands. The appliance will be fitted a week later. Molar bands will be fitted to the permanent second molar on the same appointment, with a ligature wire tying the first molar band together at the buccal tubes. The resulting anchorage reinforcement is a molar block with a transpalatal archwire.

Device: transpalatal arch group

Nance button group

EXPERIMENTAL

Bands are selected and an alginate impression taken over the bands. Bands are replaced on the tooth and an alginate impression taken over the bands. The impression will be sent to the lab for the construction of a transpalatal archwire on a 1.0 mm stainless steel wire connecting the upper permanent first molar, with a Nance button incorporated in the middle of the wire, soldered to the palatal side of the molar bands. The appliance will be fitted a week later. Molar bands will be fitted to the permanent second molar on the same appointment, with a ligature wire tying the first molar band together at the buccal tubes. The resulting anchorage reinforcement is a molar block with a Nance button

Device: Nance button

Interventions

transpalatal arch group DEVICE

transpalatal arch is a 1.0 mm stainless steel wire connecting the upper permanent first molar, with a U loop pointing posteriorly, soldered to the palatal side of the molar bands.

Also known as: TPA

TPA group

Nance button DEVICE

Nance button is a 1.0mm stainless steel wire connecting the upper permanent first molar, with a Nance button incorporated in the middle of the wire, soldered to the palatal side of the molar bands

Nance button group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with:
• a need to correct bimaxillary proclination
• age of 16 years old and above
• a need for extraction of the permanent first premolars
• mild space requirement (less than 4mm), no crowding or spaced dentition
• good oral hygiene

You may not qualify if:

• Patient with
• hypodontia
• history of orthodontic treatment or extractions (except third molars)
• congenital oral-maxillofacial deformities such as cleft lip and palate
• syndromic diseases
• orthognathic treatment need
• poor dental health precluding orthodontic treatment

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, University Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (6)

• Alqahtani ND, Alshammari R, Almoammar K, Almosa N, Almahdy A, Albarakati SF. Post-orthodontic cephalometric variations in bimaxillary protrusion cases managed by premolar extraction - A retrospective study. Niger J Clin Pract. 2019 Nov;22(11):1530-1538. doi: 10.4103/njcp.njcp_125_19.

  PMID: 31719274 BACKGROUND

• Dixon V, Read MJ, O'Brien KD, Worthington HV, Mandall NA. A randomized clinical trial to compare three methods of orthodontic space closure. J Orthod. 2002 Mar;29(1):31-6. doi: 10.1093/ortho/29.1.31.

  PMID: 11907307 BACKGROUND

• Samuels RH, Rudge SJ, Mair LH. A comparison of the rate of space closure using a nickel-titanium spring and an elastic module: a clinical study. Am J Orthod Dentofacial Orthop. 1993 May;103(5):464-7. doi: 10.1016/S0889-5406(05)81798-6.

  PMID: 8480716 BACKGROUND

• Ganzer N, Feldmann I, Bondemark L. Anchorage reinforcement with miniscrews and molar blocks in adolescents: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):758-767. doi: 10.1016/j.ajodo.2018.07.011.

  PMID: 30477773 BACKGROUND

• Solem RC, Marasco R, Guiterrez-Pulido L, Nielsen I, Kim SH, Nelson G. Three-dimensional soft-tissue and hard-tissue changes in the treatment of bimaxillary protrusion. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):218-28. doi: 10.1016/j.ajodo.2013.03.018.

  PMID: 23910203 BACKGROUND

• Vasilakos G, Schilling R, Halazonetis D, Gkantidis N. Assessment of different techniques for 3D superimposition of serial digital maxillary dental casts on palatal structures. Sci Rep. 2017 Jul 19;7(1):5838. doi: 10.1038/s41598-017-06013-5.

  PMID: 28724930 BACKGROUND

Study Officials

• Siti A Othman, MOrthRCSEd

  Faculty of Dentistry, University Malaya

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: January 12, 2021
• Study Start: January 2, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)