Clinical trial NCT06147609: Effect of Fixed and Removable Space Maintainer on Some Salivary Parameters: An In-Vivo Study
Official title: Effect of Fixed and Removable Space Maintainer on Some Salivary Parameters: An In-Vivo Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Loss of Primary Teeth
Keywords: Teeth loss
Missing teeth
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

* 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.

Eligibility criteria: 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:

* 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:

* Allergy to any used material

Primary outcomes:
measure: Assessment of salivary flow of un-stimulated saliva
timeFrame: before delivery of appliance, after 1 month, 3 months, 6 months
measure: Assessment of salivary flow of stimulated saliva
timeFrame: before delivery of appliance, after 1 month, 3 months, 6 months
measure: Assessment of Salivary pH
timeFrame: before delivery of appliance, after 1 month, 3 months, 6 months
measure: Assessment of viscosity of saliva
timeFrame: before delivery of appliance, after 1 month, 3 months, 6 months
measure: Assessment of buffering capacity
timeFrame: before delivery of appliance, after 1 month, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Faculty of medicine, Suez Canal University
Study officials:
affiliation: Lecturer
name: Yousra S Mohamed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: Srivastava V.(2011). 'Modern Pediatric Dentistry '.1 st edition. Jaypee Brothers Medical Publishers (P) Ltd, India: pp. 95-99