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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04749654
Enrollment
38
Registered
2021-02-11
Start date
2013-01-31
Completion date
2013-12-31
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Space maintainers, Streptococcus mutans, Lactobacillus, Salivary flow, Salivary pH

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.

Interventions

OTHERThe 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).

OTHERThe 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.

OTHERStreptococcus 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.

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
4 Years to 10 Years
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

Design outcomes

Primary

MeasureTime frameDescription
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASUREDbaseline-1st month measure assessing changeSalivary pH was measured by pH meter (pH= -log hydrogen ion)
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASUREDbaseline-1st month measure assessing changeStrep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASUREDbaseline-1st month measure assessing changeSaliva flow rate was computed in ml/ min
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE LACTOBACILLUS COUNTS WERE MEASUREDbaseline-1st month measure assessing changeLactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVA FLOW RATE, WERE MEASUREDbaseline-3rd month measure assessing changeSaliva flow rate was computed in ml/ min
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASUREDbaseline-3rd month measure assessing changeLactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASUREDbaseline-1st month measure assessing changeSalivary pH was measured by pH meter (pH= -log hydrogen ion)
FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASUREDbaseline-1st month measure assessing changeSaliva flow rate was computed in ml/ min
FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASUREDbaseline-1st month measure assessing changeStrep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)
FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASUREDbaseline-1st month measure assessing changeLactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026