SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT04749654
Collaborator
(none)
38
2
11

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: The Salivary pH measured
  • Other: The saliva flow rate was measured
  • Other: Streptococcus mutans and Lactobacillus counts in saliva were measured
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
EFFECTS OF SPACE MAINTAINERS ON THE SALIVARY pH, FLOW RATE, STREPTOCOCCUS MUTANS AND LACTOBACILLUS CARRIAGE: AN IN VİVO STUDY
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fixed space maintainers

band-and-loop type fixed space maintainers were applied

Other: The 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).

Other: The 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.

Other: Streptococcus 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.

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
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).

Other: The 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.

Other: Streptococcus 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.

Outcome Measures

Primary Outcome Measures

  1. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED [baseline-1st month measure assessing change]

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

  2. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-1st month measure assessing change]

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

  3. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED [baseline-1st month measure assessing change]

    Saliva flow rate was computed in ml/ min

  4. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE LACTOBACILLUS COUNTS WERE MEASURED [baseline-1st month measure assessing change]

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

  5. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED [baseline-3rd month measure assessing change]

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

  6. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVA FLOW RATE, WERE MEASURED [baseline-3rd month measure assessing change]

    Saliva flow rate was computed in ml/ min

  7. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-3rd month measure assessing change]

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

  8. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED [baseline-3rd month measure assessing change]

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

  9. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED [baseline-6 th month measure assessing change]

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

  10. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED [baseline-6 th month measure assessing change]

    Saliva flow rate was computed in ml/ min

  11. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-6 th month measure assessing change]

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

  12. FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED [baseline-6 th month measure assessing change]

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

  13. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED [baseline-1st month measure assessing change]

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

  14. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED [baseline-1st month measure assessing change]

    Saliva flow rate was computed in ml/ min

  15. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-1st month measure assessing change]

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

  16. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED [baseline-1st month measure assessing change]

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

  17. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED [baseline-3rd month measure assessing change]

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

  18. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED [baseline-3rd month measure assessing change]

    Saliva flow rate was computed in ml/ min

  19. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-3rd month measure assessing change]

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

  20. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED [baseline-3rd month measure assessing change]

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

  21. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED [baseline-6 th month measure assessing change]

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

  22. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED [baseline-6 th month measure assessing change]

    Saliva flow rate was computed in ml/ min

  23. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-6 th month measure assessing change]

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

  24. FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED [baseline-6 th month measure assessing change]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 10 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • TC Erciyes University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
esra kizilci, DDS. PhD. Assistant Prof. Dr, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT04749654
Other Study ID Numbers:
  • 149-3
First Posted:
Feb 11, 2021
Last Update Posted:
Feb 11, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by esra kizilci, DDS. PhD. Assistant Prof. Dr, TC Erciyes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2021