CClinicalTrials.gg
CompletedNCT04749654Updated Feb 11, 2021

SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

An interventional study of The Salivary pH measured and The saliva flow rate was measured in Orthodontic Appliance Complication, Lactobacillus Infection and Dental Caries in Children, sponsored by TC Erciyes University. Completed. Open to participants aged 4 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by TC Erciyes University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 years 10 months after the study started (first participant enrolled Jan 2013, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Orthodontic Appliance Complication
  • Lactobacillus Infection
  • Dental Caries in Children
  • Streptococcus, Other Specified Group

Browse trials for

Keywords

  • Space maintainers
  • Streptococcus mutans
  • Lactobacillus
  • Salivary flow
  • Salivary pH
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 38 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Fixed space maintainers

    band-and-loop type fixed space maintainers were applied

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

  • Experimental
    Removable space maintainers

    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 measured · Other: The saliva flow rate was measured · Other: Streptococcus mutans and Lactobacillus counts in saliva were measured

Interventions

  • OtherThe Salivary pH measured

    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).

  • OtherThe saliva flow rate was measured

    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.

  • OtherStreptococcus mutans and Lactobacillus counts in saliva were measured

    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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: baseline-1st month measure assessing change

  2. 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)

    Time frame: baseline-1st month measure assessing change

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

    Saliva flow rate was computed in ml/ min

    Time frame: baseline-1st month measure assessing change

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

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

    Time frame: baseline-1st month measure assessing change

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

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

    Time frame: baseline-3rd month measure assessing change

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

    Saliva flow rate was computed in ml/ min

    Time frame: baseline-3rd month measure assessing change

  7. 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)

    Time frame: baseline-3rd month measure assessing change

  8. 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)

    Time frame: baseline-3rd month measure assessing change

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

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

    Time frame: baseline-6 th month measure assessing change

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

    Saliva flow rate was computed in ml/ min

    Time frame: baseline-6 th month measure assessing change

  11. 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)

    Time frame: baseline-6 th month measure assessing change

  12. 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)

    Time frame: baseline-6 th month measure assessing change

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

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

    Time frame: baseline-1st month measure assessing change

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

    Saliva flow rate was computed in ml/ min

    Time frame: baseline-1st month measure assessing change

  15. 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)

    Time frame: baseline-1st month measure assessing change

  16. 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)

    Time frame: baseline-1st month measure assessing change

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

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

    Time frame: baseline-3rd month measure assessing change

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

    Saliva flow rate was computed in ml/ min

    Time frame: baseline-3rd month measure assessing change

  19. 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)

    Time frame: baseline-3rd month measure assessing change

  20. 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)

    Time frame: baseline-3rd month measure assessing change

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

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

    Time frame: baseline-6 th month measure assessing change

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

    Saliva flow rate was computed in ml/ min

    Time frame: baseline-6 th month measure assessing change

  23. 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)

    Time frame: baseline-6 th month measure assessing change

  24. 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)

    Time frame: baseline-6 th month measure assessing change

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04749654
Lead sponsor
TC Erciyes University
Responsible party
esra kizilci (DDS. PhD. Assistant Prof. Dr, TC Erciyes University) — Principal investigator
First posted
Feb 11, 2021
Start date
Jan 2013
Primary completion
Jul 2013
Completion
Dec 2013
Last update
Feb 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion