Orthodontic Appliance ComplicationNCT04749654
SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA
A study testing The Salivary pH measured, The saliva flow rate was measured and Streptococcus mutans and Lactobacillus counts in saliva were measured in people with Orthodontic Appliance Complication and Lactobacillus Infection, run by TC Erciyes University.
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. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication, Lactobacillus Infection, Dental Caries in Children
- What is being tested?
- The Salivary pH measured, The saliva flow rate was measured and Streptococcus mutans and Lactobacillus counts in saliva were measured
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Appliance Complication, Lactobacillus Infection, Dental Caries in Children, Streptococcus, Other Specified Group
- Being tested
- The Salivary pH measured, The saliva flow rate was measured, Streptococcus mutans and Lactobacillus counts in saliva were measured
- Keywords
- Space maintainers, Streptococcus mutans, Lactobacillus, Salivary flow, Salivary pH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Salivary pH measuredOther
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 measuredOther
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 measuredOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed space maintainers | Experimental | band-and-loop type fixed space maintainers were applied Receives: Other: The Salivary pH measured; Other: The saliva flow rate was measured; Other: Streptococcus mutans and Lactobacillus counts in saliva were measured |
| Removable space maintainers | Experimental | All removable space maintainers were produced of an acrylic base and retention elements that were a vestibule arch, (Adam's and C clasps). Receives: Other: The Salivary pH measured; Other: The saliva flow rate was measured; Other: Streptococcus mutans and Lactobacillus counts in saliva were measured |
What is being measured
The primary outcome is the main question the study is designed to answer.
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
Salivary pH was measured by pH meter (pH= -log hydrogen ion)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: baseline-6 th month measure assessing change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study startJan 2013
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra kizilci, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749654
- Sponsor's protocol ID
- 149-3
- Status last verified
- Jan 2021
- First submitted
- 16 Nov 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF SPACE MAINTAINERS ON THE SALIVARY pH, FLOW RATE, STREPTOCOCCUS MUTANS AND LACTOBACILLUS CARRIAGE: AN IN VİVO STUDY
- ClinicalTrials.gov ID
- NCT04749654
- Acronym / sponsor ID
- 149-3
- Conditions
- Orthodontic Appliance Complication, Lactobacillus Infection, Dental Caries in Children, Streptococcus, Other Specified Group
- Keywords
- Space maintainers, Streptococcus mutans, Lactobacillus, Salivary flow, Salivary pH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed space maintainers | Experimental | Other: The Salivary pH measured, Other: The saliva flow rate was measured, Other: Streptococcus mutans and Lactobacillus counts in saliva were measuredband-and-loop type fixed space maintainers were applied |
| Removable space maintainers | Experimental | Other: The Salivary pH measured, Other: The saliva flow rate was measured, Other: Streptococcus mutans and Lactobacillus counts in saliva were measuredAll removable space maintainers were produced of an acrylic base and retention elements that were a vestibule arch, (Adam's and C clasps). |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Salivary pH measuredThe 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 | Fixed space maintainers, Removable space maintainers |
| The saliva flow rate was measuredThe 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 | Fixed space maintainers, Removable space maintainers |
| Streptococcus mutans and Lactobacillus counts in saliva were measuredThe 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. | Other | Fixed space maintainers, Removable space maintainers |
Primary outcome
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline-6 th month measure assessing change
Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The Salivary pH measured, The saliva flow rate was measured and Streptococcus mutans and Lactobacillus counts in saliva were measured in people with Orthodontic Appliance Complication and Lactobacillus Infection, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED (time frame: baseline-1st month measure assessing change). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021; AzTrials last refreshed its copy on 27 Oct 2026.