NCT04749654

Brief Summary

Space maintainers are used to preserve the space after premature loss of teeth but they could effect some factors that play a role in caries formation. The research aimed to assess the impacts of removable and fixed space maintainers on the salivary pH, flow rate, and Streptococcus mutans, Lactobacillus carriage.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
Last Updated

February 11, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

November 16, 2020

Last Update Submit

February 7, 2021

Conditions

Orthodontic Appliance ComplicationLactobacillus InfectionDental Caries in ChildrenStreptococcus, Other Specified Group

Keywords

Space maintainersStreptococcus mutansLactobacillusSalivary flowSalivary pH

Outcome Measures

Primary Outcomes (24)

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED

    Salivary pH was measured by pH meter (pH= -log hydrogen ion)

    baseline-1st month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED

    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-1st month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED

    Saliva flow rate was computed in ml/ min

    baseline-1st month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE LACTOBACILLUS COUNTS WERE MEASURED

    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-1st month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED

    Salivary pH was measured by pH meter (pH= -log hydrogen ion)

    baseline-3rd month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVA FLOW RATE, WERE MEASURED

    Saliva flow rate was computed in ml/ min

    baseline-3rd month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED

    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-3rd month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED

    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-3rd month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED

    Salivary pH was measured by pH meter (pH= -log hydrogen ion)

    baseline-6 th month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED

    Saliva flow rate was computed in ml/ min

    baseline-6 th month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED

    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-6 th month measure assessing change

  • FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED

    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-6 th month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED

    Salivary pH was measured by pH meter (pH= -log hydrogen ion)

    baseline-1st month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED

    Saliva flow rate was computed in ml/ min

    baseline-1st month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED

    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-1st month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED

    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-1st month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED

    Salivary pH was measured by pH meter (pH= -log hydrogen ion)

    baseline-3rd month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED

    Saliva flow rate was computed in ml/ min

    baseline-3rd month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED

    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-3rd month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED

    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-3rd month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED

    Salivary pH was measured by pH meter (pH= -log hydrogen ion)

    baseline-6 th month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED

    Saliva flow rate was computed in ml/ min

    baseline-6 th month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED

    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-6 th month measure assessing change

  • FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED

    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

    baseline-6 th month measure assessing change

Study Arms (2)

Fixed space maintainers

EXPERIMENTAL

band-and-loop type fixed space maintainers were applied

Other: The Salivary pH measuredOther: The saliva flow rate was measuredOther: Streptococcus mutans and Lactobacillus counts in saliva were measured

Removable space maintainers

EXPERIMENTAL

All removable space maintainers were produced of an acrylic base and retention elements that were a vestibule arch, (Adam's and C clasps).

Other: The Salivary pH measuredOther: The saliva flow rate was measuredOther: Streptococcus mutans and Lactobacillus counts in saliva were measured

Interventions

The Salivary pH measuredOTHER

The saliva samples were obtained at 10-12 a.m. from all children. The saliva was collected into plastic cylinders and the salivary pH was measured with a pH meter (Compact pH meter B-212 twin pH, HORIBA, Osaka, Japan).

Fixed space maintainersRemovable space maintainers
The saliva flow rate was measuredOTHER

The saliva flow rate was estimated by during the first 30 s of paraffin chewing. The saliva was collected into plastic cylinders for a period of 5 minutes. Afterward, the saliva were weighed with a in a precision balance (Mettler PC 400, Zurich, Switzerland) and the flow rate was computed in gms/ml.

Fixed space maintainersRemovable space maintainers
Streptococcus mutans and Lactobacillus counts in saliva were measuredOTHER

The saliva samples were obtained according to described above. Numbers of colony-forming units (CFU) of S. mutans were counted on TSY20B agar and Lactobacilli were counted on Rogosa agar.

Fixed space maintainersRemovable space maintainers

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The present research was conducted on 38 patients aged between 4-10 years, each of whom had an indication for a fixed or removable space maintainer.

You may not qualify if:

  • Patients with a medical history that could influence microorganism carriage, including systemic disease, immunosuppression and the usage of antibiotics in the preceding 15 days, were excluded from the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS. PhD. Assistant Prof. Dr

Study Record Dates

First Submitted

November 16, 2020

First Posted

February 11, 2021

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

February 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share