SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: February 7, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Lactobacillus; Streptococcus mutans; Space maintainers; Salivary flow; Salivary pH
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 149-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No