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

January 5, 2024 updated by: Suez Canal University
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Ismailia, Egypt
        • Faculty of Medicine, Suez Canal University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Device: 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
Active Comparator: 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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of salivary flow of un-stimulated saliva
Time Frame: before delivery of appliance, after 1 month, 3 months, 6 months
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
Time Frame: before delivery of appliance, after 1 month, 3 months, 6 months
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
Time Frame: before delivery of appliance, after 1 month, 3 months, 6 months
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
Time Frame: before delivery of appliance, after 1 month, 3 months, 6 months
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
Time Frame: before delivery of appliance, after 1 month, 3 months, 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Principal Investigator: Yousra S Mohamed, PhD, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • space maintainers and saliva

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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