Orthodontic RetentionExtended FRNCT05889884
Eight Units Extended Maxillary Fixed Retainer
A study testing Extended maxillary fixed retainer in people with Orthodontic Retention, run by Alexandria University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 14 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Retention
- What is being tested?
- Extended maxillary fixed retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Aug 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients who finished the active orthodontic treatment and started the retention phase.
- Both genders.
- Extraction and non-extraction cases
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Orthodontic Retention
- Being tested
- Extended maxillary fixed retainer
- Keywords
- Extended fixed retainer, 3D superimposition, Fixed retainers, PDL, Quality of life, Relapse
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Fixed retainer group | Experimental | test group who undergoes retention using extended maxillary fixed retainer Receives: Device: Extended maxillary fixed retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 )
Measured: 6months follow up
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start28 Aug 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm prospect cohort study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohamed H abbas, BDS, Principal investigator, Alexandria UniversityEssam M Abdallah, PHD, Study director, Alexandria UniversityNadia M Elharoni, PHD, Study chair, Alexandria UniversityEiman S marzouk, PHD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889884
- Sponsor's protocol ID
- 0479-8/2022
- Acronym
- Extended FR
- Status last verified
- Aug 2022
- First submitted
- 18 Apr 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dental Changes Associated With an Eight Units Extended Maxillary Fixed Retainer
- ClinicalTrials.gov ID
- NCT05889884
- Acronym / sponsor ID
- Extended FR / 0479-8/2022
- Conditions
- Orthodontic Retention
- Keywords
- Extended fixed retainer, 3D superimposition, Fixed retainers, PDL, Quality of life, Relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm prospect cohort study
| Arm | Type | Receives |
|---|---|---|
| Fixed retainer group | Experimental | Device: Extended maxillary fixed retainertest group who undergoes retention using extended maxillary fixed retainer |
Who may qualify
- Ages
- 14 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who finished the active orthodontic treatment and started the retention phase.
- Both genders.
- Extraction and non-extraction cases
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended maxillary fixed retainerBonding 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 | Device | Fixed retainer group |
Primary outcome
Evaluation of dental changes
Time frame: 6 months follow up
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
lateral cephalometric changes assessment
Time frame: 6months follow up
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 )
4 secondary outcomes
PDL response through probing depth assessment
Time frame: 6 months follow up
Gingival bleeding assessment
Time frame: 6 months follow up
Plaque assessment
Time frame: 6 months follow up
Gingival assessment
Time frame: 6 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed H abbas, BDS principal investigator
Alexandria University
Essam M Abdallah, PHD study director
Alexandria University
Nadia M Elharoni, PHD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended maxillary fixed retainer in people with Orthodontic Retention, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of dental changes (time frame: 6 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.