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To assess the longevity of prefabricated versus conventional band and loop space maintainers in children with prematurely lost first primary molars.
A Randomized Clinical Trial
When considering gingival health and cement dissolution, does the longevity of the prefabricated band and loop differ from the conventional band and loop constructed following the premature loss of the lower first primary molars?
The concept of preserving space after premature tooth loss has been recognized for over a century. Conventional appliances are used successfully as space maintainers, but some disadvantages like the need for at least two visits to deliver the appliance due to laboratory work, will definitely affect its role during the general anesthesia.
The prefabricated space maintainer requires only one visit as it is fitted into the patient's mouth at the clinic without needing the dental lab. This provides a good impact on apprehensive children as it reduces the number of visits and chairside time. Prefabricated space maintainers could be a new alternative to the conventional fixed space maintainers used in pediatric dentistry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional band and loop | Active Comparator | Conventional band and loop is the most widely used space maintainer, and the most effective. It shows high success rate and good patient compliance, but it needs more than one visit to be applied. |
|
| Prefabricated band and loop | Active Comparator | Prefabricated space maintainer requires only one visit as it fits into the patient's mouth at the clinic without needing the dental lab. It comes in a kit with different band sizes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prefabricated band and loop | Device | Prefabricated space maintainer requires only one visit as it fits into the patient's mouth at the clinic without needing the dental lab. It comes in a kit with different band sizes. |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Health | By using gingival index of Loe and Silness ,scores gingival inflammation from 0-3 0 = normal gingiva
| 3 month and 9 month |
| Cement integrity | Visual inspection of cement solution by using blunt periodontal explorer and mirror, Binary (Yes, No) | 3 month and 9 month |
| Measure | Description | Time Frame |
|---|---|---|
| Space loss between the abutment teeth. | Change in distance measured on digital cast between the mesial midpoint of the second deciduous molar and the distal midpoint of the primary canine in mm. | 0 month and 9 month |
| Change in arch dimension: |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lamis A Badawi | Contact | 02001221184776 | lamis.abdelkhale@dentistry.cu.edu.eg | |
| Sherif B Eltaweil, Professor | Contact | 02001001481711 | Sherif.eltaweil@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Dina Y El Kharadly, Lecturer | October 6 University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university | Cairo | Egypt |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35082473 | Background | Kamki H, Kalaskar R, Balasubramanian S, Badhe H, Kalaskar A. Clinical Effectiveness of Fiber-reinforced Composite Space Maintainer and Band and Loop Space Maintainer in a Pediatric Patient: A Systematic Review and Meta-analysis. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S82-S93. doi: 10.5005/jp-journals-10005-2044. | |
| 31803390 | Background |
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A randomized controlled clinical trial, parallel group, allocation ratio 1:1 Framework superiority
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Blinding will not be feasible neither for the operator nor the patient. As there are some differences in the clinical steps, the form of the appliances and number of needed visits.
Outcome assessor and Statistician will be blinded from the intervention and control not knowing which group represents which procedure.
|
| Conventional Band and loop | Device | Conventional band and loop is the most widely used space maintainer, It shows high success rate and good patient compliance, but needs more than one visit due to the laboratory work. |
|
| 0 month and 9 month |
| Tahririan D, Safaripour M, Eshghi A, Bonyadian AH. Comparison of the longevity of prefabricated and conventional band and loops in children's primary teeth. Dent Res J (Isfahan). 2019 Nov 12;16(6):428-434. eCollection 2019 Nov-Dec. |
| 16823234 | Background | Padma Kumari B, Retnakumari N. Loss of space and changes in the dental arch after premature loss of the lower primary molar: a longitudinal study. J Indian Soc Pedod Prev Dent. 2006 Jun;24(2):90-6. doi: 10.4103/0970-4388.26023. |
| 38890410 | Background | Thakur B, Bhardwaj A, Luke AM, Wahjuningrum DA. Effectiveness of traditional band and loop space maintainer vs 3D-printed space maintainer following the loss of primary teeth: a randomized clinical trial. Sci Rep. 2024 Jun 18;14(1):14081. doi: 10.1038/s41598-024-61743-7. |
| 37380944 | Background | Zhao J, Jin H, Li X, Qin X. Dental arch spatial changes after premature loss of first primary molars: a systematic review and meta-analysis of split-mouth studies. BMC Oral Health. 2023 Jun 28;23(1):430. doi: 10.1186/s12903-023-03111-x. |