Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adults

Orthodontic Tooth Movement Clinical Trial

Official title:

Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adult Patients With Maxillary Dentoalveolar Protrusion: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04468295
• Other study ID #: CEBC-CU-2020-07-09
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: March 28, 2022

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study compares the rate of en-masse retraction using 0.018-inch versus 0.022-inch slot orthodontic bracket systems in adult patients with maxillary dentoalveolar protrusion.

Description:

• Proper examination of the oral structures is needed to identify caries, fracture or missing teeth.

• Full set of records ( study models, lateral cephalometric radiographs, photos) will be taken for every patient as part of the routine procedure for treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University.

• In intervention group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018-inch (American Orthodontics).

• In comparator group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.022-inch (American Orthodontics).

• Levelling and alignment in both groups with wire sequence: Ni-Ti (0.014,0.016, 0.016×0.022)

• Steel ligation of maxillary (2nd premolar, 1st molar and 2nd molar) for anchorage.

• Extraction of maxillary 1st premolars.

• Impression will be taken, poured in plaster from which digital models will be fabricated before beginning of en-masse retraction (the baseline model).

• Lateral cephalometric and periapical radiographs will be taken before starting retraction.

• En-masse retraction will be done using 0.017x0.025 TMA T-Loop10 in both groups, the loops will be reactivated monthly.

• Alginate impressions will be taken every month, that will be scanned to obtain digital models to assess the rate of retraction for 6 months.

• After 6 months, last obtained digital model will be evaluated for assessment of anchorage loss, and Lateral cephalometric and periapical radiographs will be taken to assess changes in the anterior teeth inclinations and apical root resorption respectively.

• The patients' treatment will be completed as indicated for them.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: March 28, 2022
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Maxillary dentoalveolar protrusion cases that require upper first premolars extraction.

• Full permanent dentition (not necessitating third molars).

• Good oral hygiene.

Exclusion Criteria:

• Patients having systemic diseases or on medications that would affect tooth movement.

• Active periodontal disease or obvious bone loss in maxillary arch.

• Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).

• Previous orthodontic treatment.

• Missing teeth.

Related Conditions & MeSH terms

• Orthodontic Tooth Movement

Intervention

Procedure:
• Bonding
Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch
• Leveling and alignment
Leveling and alignment till 0.016 x0.022 Ni Ti
• Extraction
Extraction of maxillary 1st premolars
• Retraction
En-masse retraction using 0.017x0.025 TMA T loop
• Digital models
impression taking and digital scanning
• measurement
Assessment the rate of retraction for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retraction Rate	The rate of en-masse retraction of the anterior teeth	6 months