SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

Sponsor

TC Erciyes University (Other)

Overall Status

Completed

CT.gov ID

NCT04749654

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Appliance Complication Lactobacillus Infection Dental Caries in Children Streptococcus, Other Specified Group	Other: The Salivary pH measured Other: The saliva flow rate was measured Other: Streptococcus mutans and Lactobacillus counts in saliva were measured	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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.

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

Other: The saliva flow rate was measured

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.

Outcome Measures

Primary Outcome Measures

FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED [baseline-1st month measure assessing change]
Salivary pH was measured by pH meter (pH= -log hydrogen ion)
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-1st month measure assessing change]
Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED [baseline-1st month measure assessing change]
Saliva flow rate was computed in ml/ min
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 FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED [baseline-3rd 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 STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-3rd month measure assessing change]
Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED [baseline-3rd 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 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)
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 pH WERE MEASURED [baseline-1st month measure assessing change]
Salivary pH was measured by pH meter (pH= -log hydrogen ion)
FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED [baseline-1st month measure assessing change]
Saliva flow rate was computed in ml/ min
FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-1st 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-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 pH WERE MEASURED [baseline-3rd month measure assessing change]
Salivary pH was measured by pH meter (pH= -log hydrogen ion)
FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED [baseline-3rd month measure assessing change]
Saliva flow rate was computed in ml/ min
FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED [baseline-3rd 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-3rd 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 pH WERE MEASURED [baseline-6 th month measure assessing change]
Salivary pH was measured by pH meter (pH= -log hydrogen ion)
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 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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