SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749654
• Other study ID #: 149-3
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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