NCT05889884

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
Last Updated

June 5, 2023

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

April 18, 2023

Last Update Submit

June 3, 2023

Conditions

Orthodontic Retention

Keywords

Extended fixed retainer3D superimpositionFixed retainersPDLQuality of lifeRelapse

Outcome Measures

Primary Outcomes (2)

  • Evaluation of dental changes

    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

    6 months follow up

  • lateral cephalometric changes assessment

    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 )

    6months follow up

Secondary Outcomes (4)

  • PDL response through probing depth assessment

    6 months follow up

  • Gingival bleeding assessment

    6 months follow up

  • Plaque assessment

    6 months follow up

  • Gingival assessment

    6 months follow up

Other Outcomes (1)

  • Quality of life assessment

    6 months follow up

Study Arms (1)

Fixed retainer group

EXPERIMENTAL

test group who undergoes retention using extended maxillary fixed retainer

Device: Extended maxillary fixed retainer

Interventions

Extended maxillary fixed retainerDEVICE

Bonding extended maxillary fixed retainer from right first maxillary premolar to left maxillary first premolar for 6 months then assessment of relapse using 3D superimposition , little index , lateral cephalometric assessment along with PDL assessment with quality of life ,function and speech assessment

Fixed retainer group

Eligibility Criteria

Age14 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry , Alexandria university

Alexandria, 21527, Egypt

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • mohamed H abbas, BDS

    Alexandria University

    PRINCIPAL INVESTIGATOR

  • Essam M Abdallah, PHD

    Alexandria University

    STUDY DIRECTOR

  • Nadia M Elharoni, PHD

    Alexandria University

    STUDY CHAIR

  • Eiman S marzouk, PHD

    Alexandria University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: single arm prospect cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

June 5, 2023

Study Start

August 28, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

June 5, 2023

Record last verified: 2022-08

Locations

EG(1)