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The aim of this study is to evaluate and compare the effect of lower lingual holding arch space maintainer versus removable partial denture space maintainer on some salivary parameters (salivary flow rate, pH, viscosity and buffering capacity).
This study is a randomized clinical trial, it will be conducted on forty children, aged from (7-10) years, who are in need for space maintainer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children with lower lingual holding arch space maintainer | Active Comparator | non functional fixed space maintainer used in the mandibular arch to maintain arch length by prevention of mesial movement of permanent first molar |
|
| children with removable partial denture space maintainer | Active Comparator | functional Removable space maintainer that not only maintain the mesiodistal space, but vertical dimension and masticatory function is also assured |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lower lingual holding arch space maintainer | Device | lower lingual holding arch space maintainer is an orthodontic device which connects two molars lower dental arch. it has an archwire, adapted to the lingual side of the lower anterior teeth, that soldered to the bands on first permanent molar |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of salivary flow of un-stimulated saliva | Un-stimulated whole saliva will be collected from all individuals by direct expectoration into a sterile container over a period of 10 min by spitting method, so that the flow rate could be calculated by dividing the amount of expectorated saliva by 10 min | before delivery of appliance, after 1 month, 3 months, 6 months |
| Assessment of salivary flow of stimulated saliva | To stimulate saliva, the subjects will be asked to chew a piece of paraffin wax, and saliva will be collected for 5 min in a measuring cup with 1ml gradation marks; the stimulated salivary flow rate (ml/min) will be calculated by dividing the amount of expectorated saliva by 5 min | before delivery of appliance, after 1 month, 3 months, 6 months |
| Assessment of Salivary pH | Salivary pH will be measured using an electronic pH meter | before delivery of appliance, after 1 month, 3 months, 6 months |
| Assessment of viscosity of saliva | Salivary viscosity will be determined by allowing saliva to flow through a tube of circular cross section to measure the flow rate . This will be done using the Ostwald viscometer. | before delivery of appliance, after 1 month, 3 months, 6 months |
| Assessment of buffering capacity | By estimating the pH change after HCl titration into un-stimulated saliva for a buffering capacity test. | before delivery of appliance, after 1 month, 3 months, 6 months |
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Inclusion Criteria:
Apparently healthy with no systemic disease. Age between 7-10 years old. Both boys and girls will be included.
Children with the following dental criteria:
Clinical criteria:
Radiographic criteria :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ALaa N Abd Ellatif | Contact | 01025757541 | PGS.03220001@dent.suez.edu.eg | |
| Asmaa A Emam, Professor | Contact | 01220989854 | asmaa_ali@dent.suez.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Yousra S Mohamed, PhD | Lecturer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Suez Canal University | Ismailia | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24326149 | Background | Alessandri Bonetti G, Incerti Parenti S, Garulli G, Gatto MR, Checchi L. Effect of fixed orthodontic appliances on salivary properties. Prog Orthod. 2013 Jun 18;14:13. doi: 10.1186/2196-1042-14-13. | |
| 24049221 | Background | Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232. |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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|
| Removable partial denture space maintainer | Device | Removable Partial Denture consists of a pink or gum-colored plastic base to which the new, artificial, replacement teeth are attached to. a metal framework holds the denture in place inside the mouth |
|
| 33378497 | Background | Dallel I, Ben Salem I, Merghni A, Bellalah W, Neffati F, Tobji S, Mastouri M, Ben Amor A. Influence of orthodontic appliance type on salivary parameters during treatment. Angle Orthod. 2020 Jul 1;90(4):532-538. doi: 10.2319/082919-562.1. |
| Background | Essawy K., Gomaa Y. & Khattab N. (2021). 'Clinical Performance of CAD /CAM Fixed Functional Space Maintainer Made of Poly Ether Ether Ketone (PEEK)'. Minia Journal of Medical Research, 32(4): pp.7-12. doi: 10.21608/mjmr.2021.241647 |
| Background | Govindaraj S., Daniel M., & Vasudevan S. & Kumaran J. (2019). 'Changes in Salivary Flow Rate, pH, and Viscosity Among Working Men and Women'. Dentistry and Medical Research, 7(2): pp. 56-59. doi:10.4103/dmr.dmr_20_19. |
| Background | Kandhan T., Jeevanandan G. & Rajasekar A. (2019). 'Prevalence of Lingual Arch Space Maintainer Among Children Between the Age Groups Of 6-10 Years - A Retrospective Study'. International Journal of Dentistry and Oral Science, 8(5): pp. 21-25. doi:10.19070/2377-8075-SI02-08005. |
| Background | Kizilci E., Arikan V., Ozalp N. & Ozcelik B. (2021) 'The Effect of Space Maintainers on Salivary pH, Flow Rate, and the Oral Microflora'. Australasian Orthodontic Journal, 37(2): pp.259-264. doi:10.21307/aoj-2021.028 |
| 35110870 | Background | Kukreja P, Hugar SM, Hallikerimath S, Sogi S, Badakar C, Thakkar P. Evaluation of the Effect of Fixed and Removable Appliances on Salivary Parameters (Salivary Flow Rate pH and Buffering Capacity) in Children Aged 5-12 Years: An In Vivo Study. Int J Clin Pediatr Dent. 2021 Nov-Dec;14(6):774-778. doi: 10.5005/jp-journals-10005-2066. |
| 16848266 | Background | Moritsuka M, Kitasako Y, Burrow MF, Ikeda M, Tagami J. The pH change after HCl titration into resting and stimulated saliva for a buffering capacity test. Aust Dent J. 2006 Jun;51(2):170-4. doi: 10.1111/j.1834-7819.2006.tb00422.x. |
| 34987584 | Background | Mosharrafian S, Baghalian A, Hamrah MH, Kargar M. Clinical Evaluation for Space Maintainer after Unilateral Loss of Primary First Molar in the Early Mixed Dentition Stage. Int J Dent. 2021 Dec 27;2021:3967164. doi: 10.1155/2021/3967164. eCollection 2021. |
| 30983825 | Background | Ramakrishnan M, Dhanalakshmi R, Subramanian EMG. Survival rate of different fixed posterior space maintainers used in Paediatric Dentistry - A systematic review. Saudi Dent J. 2019 Apr;31(2):165-172. doi: 10.1016/j.sdentj.2019.02.037. Epub 2019 Feb 14. |
| 36866140 | Background | Sathyaprasad S, Krishnareddy MG, Vinod V, Das N, Ramesh R, Ilyas I. Comparative Evaluation of Fixed Functional Cantilever Space Maintainer and Fixed Nonfunctional Space Maintainer: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2022 Nov-Dec;15(6):750-760. doi: 10.5005/jp-journals-10005-2478. |
| Background | Sethuraman G., Daniel M., Vasudevan S. & Kumaran J. (2019). 'Changes in Salivary Flow Rate, pH, and Viscosity among Working Men and Women'. Dentistry and Medical Research, 7(2): pp. 56-59. doi: 10.4103/dmr.dmr_20_19 |
| Background | Srivastava V.(2011). 'Modern Pediatric Dentistry '.1 st edition. Jaypee Brothers Medical Publishers (P) Ltd, India: pp. 95-99 |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |