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Completed

NCT Number: NCT04749654

SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

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.

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Key information

Conditions

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

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Salivary pH measured

Other

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).

The saliva flow rate was measured

Other

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.

Streptococcus mutans and Lactobacillus counts in saliva were measured

Other

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 outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: baseline-6 th month measure assessing change

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

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

EFFECTS OF SPACE MAINTAINERS ON THE SALIVARY pH, FLOW RATE, STREPTOCOCCUS MUTANS AND LACTOBACILLUS CARRIAGE: AN IN VİVO STUDY

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2021
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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