Effect of Fixed and Removable Space Maintainer on Some Salivary Parameters: An In-Vivo Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effect of Fixed and Removable Space Maintainer on Some Salivary Parameters: An In-Vivo Study

Conditions
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Premature Loss of Primary Teeth

Intervention / Treatment
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* Device: lower lingual holding arch space maintainer
* Device: Removable partial denture space maintainer


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: children with lower lingual holding arch space maintainer<br>non functional fixed space maintainer used in the mandibular arch to maintain arch length by prevention of mesial movement of permanent first molar | Device: lower lingual holding arch space maintainer<br>* 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<br>|
| Active Comparator: children with removable partial denture space maintainer<br>functional Removable space maintainer that not only maintain the mesiodistal space, but vertical dimension and masticatory function is also assured | Device: Removable partial denture space maintainer<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Teeth loss, Missing teeth