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Clinical Trials/NCT05889884
NCT05889884CompletedNot Applicable

Evaluation of the Dental Changes Associated With an Eight Units Extended Maxillary Fixed Retainer

Alexandria University1 site in 1 country26 target enrollmentStarted: August 28, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
lateral cephalometric changes assessment

Study Overview

Brief Summary

Assessment of dental changes associated with an eight-unit extended maxillary fixed retainer in 3D. monitoring PDL response and evaluation of patient's satisfaction ,quality of life and speech with extended maxillary fixed retainer

Detailed Description

single-arm prospective clinical trial will be conducted to assess of dental changes associated with an eight-unit extended maxillary fixed retainer in 3D. monitoring PDL response and evaluation of patient's satisfaction ,quality of life and speech with extended maxillary fixed retainer.

. Twenty-six patients who finished the active orthodontic treatment phase (14-28 years) will be recruited upon complying with the inclusion criteria. Eight-unit extended maxillary fixed retainer will be bonded to palatal surface of maxillary incisors, canines and first premolars, PDL assessment will be carried out and patient acceptance to the appliance through the valid questionnaire then the patients will be followed up for 6 months to document 3D post-treatment changes.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
14 Years to 28 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients who finished the active orthodontic treatment and started the retention phase.
  • •Both genders.
  • •Extraction and non-extraction cases

Exclusion Criteria

  • •Patients who had active transverse palatal expansion.
  • •Patients with active periodontal disease.
  • •Patients with systemic disease and bone diseases, or craniofacial syndromes, or the presence of cleft.
  • •Patients with abnormal surface or morphological tooth structure or restorations.

Arms & Interventions

Fixed retainer group

Experimental

test group who undergoes retention using extended maxillary fixed retainer

Intervention: Extended maxillary fixed retainer (Device)

Outcomes

Primary Outcomes

lateral cephalometric changes assessment

Time Frame: 6months follow up

evaluation of the changes of axial inclination of upper incisors before bonding fixed retainer and 6 months after bonding the retainer through measuring the axial inclination changes of upper incisors(u1-sn angle( upper 1 relation to cranial base ) , interincisal angle( angle between upper and lower incisors ) ,u1- FH angle( angle between upper incisor and Frankfort horizontal plane ) ,u1 to palatal plane angle (angle between upper incisor to palatal plane ), u1 to occlusal plane(angle between upper incisor and occlusal plane )

Evaluation of dental changes

Time Frame: 6 months follow up

3D Evaluation of the dental changes associated with an eight unit extended maxillary fixed retainer by superimposition of STL files before bonding and 6 months after bonding fixed retainer which is bonded directly after completion of active orthodontic phase, the changes in teeth position will be assessed by linear differences between the first stl and final stl file after superimposing them using medit software , on demand software ,creating linear measurement that calculate how teeth moved in antroposterior plane , transverse and vertical planes

Secondary Outcomes

  • PDL response through probing depth assessment(6 months follow up)
  • Plaque assessment(6 months follow up)
  • Gingival bleeding assessment(6 months follow up)
  • Gingival assessment(6 months follow up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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