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

Suez Canal University

Status: Not yet enrolling

Conditions: Premature Loss of Primary Teeth

Treatments: Device: Removable partial denture space maintainer; Device: lower lingual holding arch space maintainer

Study type: Interventional

Funder types: Other

Identifiers

NCT06147609

space maintainers and saliva

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

children with lower lingual holding arch space maintainer

Active Comparator group

Description:

non functional fixed space maintainer used in the mandibular arch to maintain arch length by prevention of mesial movement of permanent first molar

Treatment:

Device: lower lingual holding arch space maintainer

children with removable partial denture space maintainer

Active Comparator group

Description:

functional Removable space maintainer that not only maintain the mesiodistal space, but vertical dimension and masticatory function is also assured

Treatment:

Device: Removable partial denture space maintainer