Effect of Fixed and Removable Space Maintainer on Some Salivary Parameters: An In-Vivo Study
NCT ID: NCT06147609
Last Updated: 2024-01-08
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-01-31
2024-12-31
Brief Summary
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Detailed Description
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* Children will be randomly and equally divided into two groups according to type of space maintainer used; group (1): twenty children with lower lingual holding arch, group (2): twenty children with removable partial denture.
* Un-stimulated and stimulated saliva will be collected at specific duration of time from children before the delivery of the appliance and after 1, 3 and 6 months of wearing the space maintainer to measure salivary flow rate, pH, viscosity and buffering capacity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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children with lower lingual holding arch space maintainer
non functional fixed space maintainer used in the mandibular arch to maintain arch length by prevention of mesial movement of permanent first molar
lower lingual holding arch space maintainer
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
children with removable partial denture space maintainer
functional Removable space maintainer that not only maintain the mesiodistal space, but vertical dimension and masticatory function is also assured
Removable partial denture space maintainer
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
Interventions
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lower lingual holding arch space maintainer
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
Removable partial denture space maintainer
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
Eligibility Criteria
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Inclusion Criteria
Children with the following dental criteria:
Clinical criteria:
* Children should have a good oral hygiene.
* Children in mixed dentition stage.
* Fully erupted permanent lower first molar.
* Children with multiple loss of deciduous molar teeth.
* Seek for space maintainer appliance.
Radiographic criteria :
* Presence of at least 1mm bone overlaying successor.
* Tooth germ with less than one third of the root formed.
Exclusion Criteria
7 Years
10 Years
ALL
Yes
Sponsors
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Suez Canal University
OTHER
Responsible Party
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Principal Investigators
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Yousra S Mohamed, PhD
Role: PRINCIPAL_INVESTIGATOR
Lecturer
Locations
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Faculty of medicine, Suez Canal University
Ismailia, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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
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.
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.
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
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.
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.
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.
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.
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.
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
Srivastava V.(2011). 'Modern Pediatric Dentistry '.1 st edition. Jaypee Brothers Medical Publishers (P) Ltd, India: pp. 95-99
Other Identifiers
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space maintainers and saliva
Identifier Type: -
Identifier Source: org_study_id
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