Eight Units Extended Maxillary Fixed Retainer

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.

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

Conditions
-----------------
Orthodontic Retention

Intervention / Treatment
-----------------
* Device: Extended maxillary fixed retainer


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 28 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: single arm prospect cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed retainer group<br>test group who undergoes retention using extended maxillary fixed retainer | Device: Extended maxillary fixed retainer<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDL response through probing depth assessment | Evaluation of PDL changes associated with the extended upper fixed retainer through comparison of probing depth changes before bonding the retainer and 6 months after bonding Probing depth:- is the distance from the gingival margin to the base of the sulcus or periodontal pocket. Normal range (1-3mm) the differences in probing depth readings will reflect either negative or no effect of fixed retainer on PDL | 6 months follow up | 
| Gingival bleeding assessment | Evaluation of PDL changes associated with the extended upper fixed retainer through calculating bleeding index before bonding and after 6 months of bonding fixed retainer Bleeding index:- method used to assess bleeding in the interdental tissues and gingiva. 0: No bleeding. 1: Only one bleeding point appearing. 2: Several isolated bleeding points or a small blood area appearing. 3: Interdental triangle filled with blood soon after probing. 4: Profuse bleeding when probing, blood spreads towards the marginal gingiva. Changes in bleeding index will express effects of Fixed retainer on peridontium negatively or positively. | 6 months follow up | 
| Plaque assessment | Evaluation of PDL changes associated with the extended upper fixed retainer through calculating plaque index before bonding and after 6 months of bonding fixed retainer Plaque index:- method used to assess the amount of plaque on teeth.0 = No plaque in the gingival area. 1 = Separate flecks of plaque at the cervical margin of the tooth. 2 = A thin continuous band of plaque (up to 1 mm) at the cervical margin. 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.Changes in plaque index will express effects of Fixed retainer on PDL negatively or positively. | 6 months follow up | 
| Gingival assessment | Evaluation of PDL changes associated with the extended upper fixed retainer through calculating gingival index before bonding and after 6 months of bonding fixed retainer Gingival index:- method used to assess the severity of gingivitis.0 Normal gingiva Slight change in color, slight edema. No change on probing.1 Mild inflammation 2 Moderate inflammation Redness, edema, and glazing. Bleeding on probing. 3 Severe inflammation Marked redness and edema, ulceration. Tendency to spontaneous bleeding. Changes in gingival index readings will express effects of Fixed retainer on PDL negatively or positively. | 6 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extended fixed retainer, 3D superimposition, Fixed retainers, PDL, Quality of life, Relapse