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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06147609
Enrollment
40
Registered
2023-11-27
Start date
2024-01-31
Completion date
2024-12-31
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Loss of Primary Teeth

Keywords

Teeth loss, Missing teeth

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.

Interventions

DEVICElower 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

DEVICERemovable 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

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of salivary flow of un-stimulated salivabefore delivery of appliance, after 1 month, 3 months, 6 monthsUn-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
Assessment of salivary flow of stimulated salivabefore delivery of appliance, after 1 month, 3 months, 6 monthsTo 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
Assessment of Salivary pHbefore delivery of appliance, after 1 month, 3 months, 6 monthsSalivary pH will be measured using an electronic pH meter
Assessment of viscosity of salivabefore delivery of appliance, after 1 month, 3 months, 6 monthsSalivary 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.
Assessment of buffering capacitybefore delivery of appliance, after 1 month, 3 months, 6 monthsBy estimating the pH change after HCl titration into un-stimulated saliva for a buffering capacity test.

Countries

Egypt

Contacts

Primary ContactALaa N Abd Ellatif
PGS.03220001@dent.suez.edu.eg01025757541
Backup ContactAsmaa A Emam, Professor
asmaa_ali@dent.suez.edu.eg01220989854

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026