SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

Not Applicable

Completed

• Conditions: Lactobacillus Infection; Orthodontic Appliance Complication; Streptococcus, Other Specified Group; Dental Caries in Children
• Interventions: Other: The Salivary pH measured; Other: The saliva flow rate was measured; Other: Streptococcus mutans and Lactobacillus counts in saliva were measured

• Registration Number: NCT04749654
• Lead Sponsor: TC Erciyes University

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.

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 Timeline

• Study Start: 2013-01
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Study First Submitted: 2020-11-16
• Status Verified: 2021-01
• Study First Submitted QC: 2021-02-07
• Last Update Submitted: 2021-02-07
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed space maintainers	Streptococcus mutans and Lactobacillus counts in saliva were measured	band-and-loop type fixed space maintainers were applied
Fixed space maintainers	The saliva flow rate was measured	band-and-loop type fixed space maintainers were applied
Removable space maintainers	Streptococcus mutans and Lactobacillus counts in saliva were measured	All removable space maintainers were produced of an acrylic base and retention elements that were a vestibule arch, (Adam's and C clasps).
Removable space maintainers	The Salivary pH measured	All removable space maintainers were produced of an acrylic base and retention elements that were a vestibule arch, (Adam's and C clasps).
Removable space maintainers	The saliva flow rate was measured	All removable space maintainers were produced of an acrylic base and retention elements that were a vestibule arch, (Adam's and C clasps).
Fixed space maintainers	The Salivary pH measured	band-and-loop type fixed space maintainers were applied

Primary Outcome Measures

Name	Time	Method
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)
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)
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)
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)
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
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
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)
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)
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
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)