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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04749654
Other study ID # 149-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date December 2013

Study information

Verified date January 2021
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 10 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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).
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Outcome

Type Measure Description Time frame Safety issue
Primary FOR FiXED SPACE MAiNTAiNERS: CHANGES ON THE SALIVARY pH WERE MEASURED Salivary pH was measured by pH meter (pH= -log hydrogen ion) baseline-1st month measure assessing change
Primary FOR FiXED SPACE MAiNTAiNERS: 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
Primary FOR FiXED SPACE MAiNTAiNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED Saliva flow rate was computed in ml/ min baseline-1st month measure assessing change
Primary FOR FiXED SPACE MAiNTAiNERS: 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
Primary FOR FiXED SPACE MAiNTAiNERS: CHANGES ON THE SALIVARY pH WERE MEASURED Salivary pH was measured by pH meter (pH= -log hydrogen ion) baseline-3rd month measure assessing change
Primary FOR FiXED SPACE MAiNTAiNERS: CHANGES ON THE SALIVA FLOW RATE, WERE MEASURED Saliva flow rate was computed in ml/ min baseline-3rd month measure assessing change
Primary FOR FiXED SPACE MAiNTAiNERS: 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
Primary FOR FiXED SPACE MAiNTAiNERS: 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
Primary FOR FiXED SPACE MAiNTAiNERS: 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
Primary FOR FiXED SPACE MAiNTAiNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED Saliva flow rate was computed in ml/ min baseline-6 th month measure assessing change
Primary FOR FiXED SPACE MAiNTAiNERS: 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
Primary FOR FiXED SPACE MAiNTAiNERS: 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
Primary FOR REMOVABLE SPACE MAiNTAiNERS: CHANGES ON THE SALIVARY pH WERE MEASURED Salivary pH was measured by pH meter (pH= -log hydrogen ion) baseline-1st month measure assessing change
Primary FOR REMOVABLE SPACE MAiNTAiNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED Saliva flow rate was computed in ml/ min baseline-1st month measure assessing change
Primary FOR REMOVABLE SPACE MAiNTAiNERS: 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
Primary FOR REMOVABLE SPACE MAiNTAiNERS: 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
Primary FOR REMOVABLE SPACE MAiNTAiNERS: CHANGES ON THE SALIVARY pH WERE MEASURED Salivary pH was measured by pH meter (pH= -log hydrogen ion) baseline-3rd month measure assessing change
Primary FOR REMOVABLE SPACE MAiNTAiNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED Saliva flow rate was computed in ml/ min baseline-3rd month measure assessing change
Primary FOR REMOVABLE SPACE MAiNTAiNERS: 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
Primary FOR REMOVABLE SPACE MAiNTAiNERS: 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
Primary FOR REMOVABLE SPACE MAiNTAiNERS: 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
Primary FOR REMOVABLE SPACE MAiNTAiNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED Saliva flow rate was computed in ml/ min baseline-6 th month measure assessing change
Primary FOR REMOVABLE SPACE MAiNTAiNERS: 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
Primary FOR REMOVABLE SPACE MAiNTAiNERS: 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
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