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The main goal is to test the differences between the retentive capacity of fixed retainer, vacuum-formed retainer & combination of both; and recommend the most effective protocol for retention of lower incisors crowding treated by non-extraction treatment plan
The main question is: In patients with lower incisors crowding treated by non-extraction treatment plans, what is the difference in retentive capacity between fixed retainer, vacuum formed retainer and combined bonded and vacuum retainers in maintaining corrected lower anterior segment crowding? After enrolment, each participant will have the orthodontic appliance debonded, the adhesive remnant removed and the enamel surface polished. An alginate impression will be taken to be poured into a study model which will be scanned to obtain STL files for digital models. All patients will have periodontal charting and probing depths recorded for the lower anterior segment. According to the randomization, each patient will be assigned to a group to receive the retainer. All patients will be called for follow-up after 1 week, 1 and 3 months.
Research objective: Retention is a key part of success of orthodontic treatment. Unless we can maintain the teeth in position after orthodontic treatment, the beneficial results of the treatment can be lost. There are currently many different types, designs and materials of removable and fixed retainers and it is unclear which retainers are the best, and how long they should be used for. There is also little knowledge about the possible adverse effects on the Periodontal health, patients' satisfaction and compliance are better with which type of retainers; and which retainers have the greatest failure rate. The dual retention protocol -combined vacuum and fixed retainers- is widely used among clinicians but without strong evidence on its effectiveness compared to the use of single retainer.
Research procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Orthodontics department, Faculty of Dentistry, Cairo University.
Eligibility criteria:
Inclusion criteria:
Exclusion criteria:
Interventions:
Clinical Procedure:
Intervention group I:
Vacuum-formed retainer.
Intervention group II:
Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.
Control group III:
Lingual bonded retainer from canine-to-canine.
All the three groups will be called for follow up after 1week T1, 1month T2 and 3 months T3.
At each follow up visit, an alginate impression will be taken to obtain a study cast which will be later scanned to get a digital model and a periodontal chart will be filled to evaluate the periodontal condition; also, the integrity of the retainers will be checked together with the rate of failure or debonding of the fixed retainer which will be recorded.
The compliance chart will be collected and a new one will be supplied.
Outcomes: Relapse, Patient's compliance and satisfaction, Periodontal health, Integrity of the retainer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum-formed retainer | Experimental | An alginate impression will be taken to be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used. |
|
| Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. | Experimental | A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors; followed by an alginate impression; the impression will be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used. |
|
| Lingual bonded retainer from canine-to-canine | Active Comparator | A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum-formed retainer | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The stability of the orthodontic treatment result and the degree of relapse from baseline to 6 months | The stability of the orthodontic treatment result and the degree of relapse will be measured by superimposition of the digital model at each time point on the initial model after debonding at T0. | Relapse will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's compliance | patients' compliance will be evaluated by the check list supplied at each time point for the groups using removable retainers. | It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadeer A. ElBehery, Bachelor | Contact | +201064618667 | hadeer.elbehery@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hadeer A. ElBehery, Bachelor | Cairo University | Principal Investigator |
| Fady H. Fahim, Ass Professor | Cairo University | Study Director |
| Sally M. Reyad, Lecturer |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Recruiting | Cairo | Egypt |
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| Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. | Device |
|
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| Lingual bonded retainer from canine-to-canine | Device |
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| Periodontal health |
Periodontal health will be monitored by a filling a periodontal chart at each time point to check the probing depth, bleeding on probing and calculus formation on the lingual surface of lower anteriors. |
| It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner |
| The integrity of the retainers | The integrity of the retainers will be evaluated based on the rate of fracture/ debonding and loss of the retainer. | It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner |
| Patient's satisfaction | Patients' satisfaction will be evaluated at each follow up visit, the patients in all groups will fill a questionnaire form. | It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner |
| Cairo University |
| Study Chair |