Eight Units Extended Maxillary Fixed Retainer (Extended FR)

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

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

Study Overview

• Status: Completed
• Conditions: Orthodontic Retention
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Faculty of dentistry , Alexandria university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed retainer group; test group who undergoes retention using extended maxillary fixed retainer	Device: 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment	Evaluation of the quality of life ,through A-Oral Health Impact Profile (OHIP-14) valid and reliable tool for assessing oral health quality of life among the adults.The responses are rated on a 5-point Likert scale: 0-never,1-hardly ever,2-occasionally,3-fairly often,4-very often/every day. The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items B-Acceptance questionnaire It consists of 10 incomplete statements,needed to be completed by patient's choice. The available answer choices were scored using a 6-point Likert scale. To help patients understand the answers, answers were accompanied by facial expression. Scores 5 to 0 were allocated to the answer choices from left to right.The higher scores the higher satisfaction with the item. The total score of this tool ranged from 0 to 55. A higher total score indicated that the problems of using the orthodontic appliance were better accepted by patient and motivation to continue.	6 months follow up

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: mohamed H abbas, BDS, Alexandria University; Study Director: Essam M Abdallah, PHD, Alexandria University; Study Chair: Nadia M Elharoni, PHD, Alexandria University; Study Chair: Eiman S marzouk, PHD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: June 3, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 3, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Relapse; PDL; Extended fixed retainer; 3D superimposition; Fixed retainers
• Other Study ID Numbers: 0479-8/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No