Clinical trial NCT05889884: Eight Units Extended Maxillary Fixed Retainer
Official title: Evaluation of the Dental Changes Associated With an Eight Units Extended Maxillary Fixed Retainer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Retention
Keywords: Extended fixed retainer
3D superimposition
Fixed retainers
PDL
Quality of life
Relapse
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 26
Sex: ALL
Minimum age (years): 14
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm prospect cohort study
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of dental changes
timeFrame: 6 months follow up
measure: lateral cephalometric changes assessment
timeFrame: 6months follow up
Secondary outcomes:
measure: PDL response through probing depth assessment
timeFrame: 6 months follow up
measure: Gingival bleeding assessment
timeFrame: 6 months follow up
measure: Plaque assessment
timeFrame: 6 months follow up
measure: Gingival assessment
timeFrame: 6 months follow up
Other outcomes:
measure: Quality of life assessment
timeFrame: 6 months follow up
Locations:
city: Alexandria
country: Egypt
facility: Faculty of dentistry , Alexandria university
Study officials:
affiliation: Alexandria University
name: mohamed H abbas, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Essam M Abdallah, PHD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Nadia M Elharoni, PHD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Eiman S marzouk, PHD
role: STUDY_CHAIR
References: