search
Back to results

SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

Primary Purpose

Orthodontic Appliance Complication, Lactobacillus Infection, Dental Caries in Children

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Salivary pH measured
The saliva flow rate was measured
Streptococcus mutans and Lactobacillus counts in saliva were measured
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Orthodontic Appliance Complication focused on measuring Space maintainers, Streptococcus mutans, Lactobacillus, Salivary flow, Salivary pH

Eligibility Criteria

4 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Fixed space maintainers

    Removable space maintainers

    Arm Description

    band-and-loop type fixed space maintainers were applied

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

    Outcomes

    Primary Outcome Measures

    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    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)
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Saliva flow rate was computed in ml/ min
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE LACTOBACILLUS COUNTS WERE MEASURED
    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVA FLOW RATE, WERE MEASURED
    Saliva flow rate was computed in ml/ min
    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)
    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)
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Saliva flow rate was computed in ml/ min
    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)
    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)
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Saliva flow rate was computed in ml/ min
    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)
    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)
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Saliva flow rate was computed in ml/ min
    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)
    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)
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Saliva flow rate was computed in ml/ min
    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)
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2020
    Last Updated
    February 7, 2021
    Sponsor
    TC Erciyes University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04749654
    Brief Title
    SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA
    Official Title
    EFFECTS OF SPACE MAINTAINERS ON THE SALIVARY pH, FLOW RATE, STREPTOCOCCUS MUTANS AND LACTOBACILLUS CARRIAGE: AN IN VİVO STUDY
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (Actual)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Although the usage of space maintainers can reduce the severity of problems that arise from the early loss of teeth, there are concerns regarding the impact of fixed and removable appliances on factors that can lead to dental caries. All space maintainer appliances are plaque retentive since bands and brackets increase the retention of plaque and food on tooth surfaces, reduce the clearance of plaque by saliva and make conventional oral hygiene for plaque removal more difficult, therefore, they may cause caries development.Space maintainers can favor caries formation by changing the oral microflora. patients aged between 4-10 years, each of whom had an indication for a fixed (n=19) or removable space maintainer (n=19), were enrolled in this research. The salivary pH, saliva flow rate, Streptococcus mutans and Lactobacillus counts in saliva were measured just prior to the application of space maintainers (baseline-T0) and in the course of the follow-up; at the 1st (T1), 3rd (T2), and 6th (T3) months. The Wilcoxon, Mann-Whithney U test and Friedman tests were used for statistical analyses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orthodontic Appliance Complication, Lactobacillus Infection, Dental Caries in Children, Streptococcus, Other Specified Group
    Keywords
    Space maintainers, Streptococcus mutans, Lactobacillus, Salivary flow, Salivary pH

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fixed space maintainers
    Arm Type
    Experimental
    Arm Description
    band-and-loop type fixed space maintainers were applied
    Arm Title
    Removable space maintainers
    Arm Type
    Experimental
    Arm Description
    All removable space maintainers were produced of an acrylic base and retention elements that were a vestibule arch, (Adam's and C clasps).
    Intervention Type
    Other
    Intervention Name(s)
    The Salivary pH measured
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    The saliva flow rate was measured
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Streptococcus mutans and Lactobacillus counts in saliva were measured
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Description
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    Time Frame
    baseline-1st month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED
    Description
    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-1st month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Description
    Saliva flow rate was computed in ml/ min
    Time Frame
    baseline-1st month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE LACTOBACILLUS COUNTS WERE MEASURED
    Description
    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-1st month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Description
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    Time Frame
    baseline-3rd month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVA FLOW RATE, WERE MEASURED
    Description
    Saliva flow rate was computed in ml/ min
    Time Frame
    baseline-3rd month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED
    Description
    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-3rd month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED
    Description
    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-3rd month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Description
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    Time Frame
    baseline-6 th month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Description
    Saliva flow rate was computed in ml/ min
    Time Frame
    baseline-6 th month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED
    Description
    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-6 th month measure assessing change
    Title
    FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED
    Description
    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-6 th month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Description
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    Time Frame
    baseline-1st month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Description
    Saliva flow rate was computed in ml/ min
    Time Frame
    baseline-1st month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED
    Description
    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-1st month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED
    Description
    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-1st month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Description
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    Time Frame
    baseline-3rd month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Description
    Saliva flow rate was computed in ml/ min
    Time Frame
    baseline-3rd month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED
    Description
    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-3rd month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED
    Description
    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-3rd month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
    Description
    Salivary pH was measured by pH meter (pH= -log hydrogen ion)
    Time Frame
    baseline-6 th month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED
    Description
    Saliva flow rate was computed in ml/ min
    Time Frame
    baseline-6 th month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED
    Description
    Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-6 th month measure assessing change
    Title
    FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED
    Description
    Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
    Time Frame
    baseline-6 th month measure assessing change

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

    We'll reach out to this number within 24 hrs