Eight Units Extended Maxillary Fixed Retainer

NCT ID: NCT05889884

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-28

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthodontic Retention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

single arm prospect cohort study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fixed retainer group

test group who undergoes retention using extended maxillary fixed retainer

Group Type EXPERIMENTAL

Extended maxillary fixed retainer

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Extended maxillary fixed retainer

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexandria University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

mohamed H abbas, BDS

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Essam M Abdallah, PHD

Role: STUDY_DIRECTOR

Alexandria University

Nadia M Elharoni, PHD

Role: STUDY_CHAIR

Alexandria University

Eiman S marzouk, PHD

Role: STUDY_CHAIR

Alexandria University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of dentistry , Alexandria university

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0479-8/2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.