Gingivitis; ChronicNCT03455192
Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis
A study testing Synbiotic Supplement in people with Gingivitis; Chronic and Smoking, run by Kırıkkale University.
Trial summary
The aim of this study is to evaluate the efficacy of oral administration of synbiotic tablets on the clinical parameters and the levels of selected inflammatory mediators in gingival crevicular fluid (GCF) in smokers and non-smokers with gingivitis. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis; Chronic, Smoking
- What is being tested?
- Synbiotic Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2014to 29 Jun 2015
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy subjects
- Clinical diagnosis of gingivitis
Who cannot join
- Subjects who had used any systemic antibiotics in the previous 3 months,
- Subjects who had used a product containing probiotics in the previous month
- Systemic disease or condition that could interfere with the study results
- Ongoing drug therapy that could affect the signs of gingivitis
- Subjects who were received periodontal treatment in the last 6 months and
- Allergic to milk and milk products
About this study
Official title: The Effect of Synbiotic Tablet Usage on the Clinical and Biochemical Parameters in Smokers and Nonsmokers With Gingivitis: A Randomized Placebo-Controlled Clinical Trial
The aim of this study is to evaluate the efficacy of oral administration of synbiotic tablets on the clinical parameters and the levels of selected inflammatory mediators in gingival crevicular fluid (GCF) in smokers and non-smokers with gingivitis.
This study designed as a double-blind randomized placebo-controlled clinical trial.
Read the detailed description
Some patients like smokers have ongoing host response even after bacterial plaque removal achieved. Therefore efforts to develop effective treatment approaches remain an important objective in the treatment of gingivitis to prevent periodontitis especially in patients at high risk for developing periodontitis as smokers.
Smoking is a major risk factor for the incidence and the progression of periodontal diseases. The increased periodontal disease susceptibility in smokers is predominantly caused by changes in inflammatory and immune responses. Cigarette smoking also influences the amount and the composition of subgingival plaque. Smokers have higher numbers of pathogens in their resident biofilm and display an ongoing host response even after biofilm removal. Different approaches were explored to reduce the negative effects of smoking on the outcomes of periodontal therapy Synbiotic were defined as a mixture of probiotics and prebiotics that beneficially affects the host by improving the survival and implantation of live microbial dietary supplements in the gastrointestinal tract, by selectively stimulating the growth and/or by activating the metabolism of one or a limited number of health-promoting bacteria, and thus improving host welfare. Also in some cases, this may lead to a competitive advantage for the probiotics among with other bacteria.
- Conditions
- Gingivitis; Chronic, Smoking
- Being tested
- Synbiotic Supplement, Placebo Oral Tablet
- Keywords
- gingivitis, gingival crevicular fluid, probiotics, smoking, periodontal medicine
- Medical subject headings
- Gingivitis, Bronchiolitis Obliterans Syndrome, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic SupplementDrug
Also called NOBEL (NBL) Probiotic Optima
Placebo Oral TabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic supplements | Experimental | One synbiotic tablet, per day, during 30 days Receives: Drug: Synbiotic Supplement |
| Placebo Oral Tablet | Placebo comparator | One placebo tablet , per day, during 30 days Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Interleukin (IL)-6 level of GCF at 2 months
GCF samples were collected with paper strips and IL-6 levels of GCF were measured using commercial kits by using ELISA method
Measured: baseline, 1st and 2nd months
Change from Baseline IL-8 level of GCF at 2 months
GCF samples were collected with paper strips and IL-8 levels of GCF were measured using commercial kits by using ELISA method
Measured: baseline, 1st and 2nd months
Change from Baseline IL-10 level of GCF at 2 months
GCF samples were collected with paper strips and IL-10 levels of GCF were measured using commercial kits by using ELISA method
Measured: baseline, 1st and 2nd months
Secondary outcomes (3)
Change from Baseline GCF volume at 2 months
Clinical parameter
Measured: baseline, 1st and 2nd months
Change from Baseline Gingival Index at 2 months
Clinical parameter
Measured: baseline, 1st and 2nd months
Change from Baseline Plaque Index at 2 months
Clinical parameter
Measured: baseline, 1st and 2nd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start22 Jul 2014
- Primary completion29 Jun 2015
- Study completion29 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingivitis; ChronicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- double-blind randomized placebo-controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Ercan, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455192
- Sponsor's protocol ID
- 2014/01
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 6 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Randomization was performed by one researcher that had never any role in participant's treatment and clinical measurement processes (E.O.E). Patients' all measurements and treatments were made by a single researcher who doesn't know in which group participants were included (N.E.).
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Synbiotic Tablet Usage on the Clinical and Biochemical Parameters in Smokers and Nonsmokers With Gingivitis: A Randomized Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03455192
- Acronym / sponsor ID
- 2014/01
- Conditions
- Gingivitis; Chronic, Smoking
- Keywords
- gingivitis, gingival crevicular fluid, probiotics, smoking, periodontal medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 22 Jul 2014 (actual)
- Primary completion
- 29 Jun 2015 (actual)
- Study completion
- 29 Jun 2015 (actual)
- First posted
- 6 Mar 2018 (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.
The aim of this study is to evaluate the efficacy of oral administration of synbiotic tablets on the clinical parameters and the levels of selected inflammatory mediators in gingival crevicular fluid (GCF) in smokers and non-smokers with gingivitis.
This study designed as a double-blind randomized placebo-controlled clinical trial.
Detailed description
Some patients like smokers have ongoing host response even after bacterial plaque removal achieved. Therefore efforts to develop effective treatment approaches remain an important objective in the treatment of gingivitis to prevent periodontitis especially in patients at high risk for developing periodontitis as smokers.
Smoking is a major risk factor for the incidence and the progression of periodontal diseases. The increased periodontal disease susceptibility in smokers is predominantly caused by changes in inflammatory and immune responses. Cigarette smoking also influences the amount and the composition of subgingival plaque. Smokers have higher numbers of pathogens in their resident biofilm and display an ongoing host response even after biofilm removal. Different approaches were explored to reduce the negative effects of smoking on the outcomes of periodontal therapy Synbiotic were defined as a mixture of probiotics and prebiotics that beneficially affects the host by improving the survival and implantation of live microbial dietary supplements in the gastrointestinal tract, by selectively stimulating the growth and/or by activating the metabolism of one or a limited number of health-promoting bacteria, and thus improving host welfare. Also in some cases, this may lead to a competitive advantage for the probiotics among with other bacteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blind randomized placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Synbiotic supplements | Experimental | Drug: Synbiotic SupplementOne synbiotic tablet, per day, during 30 days |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletOne placebo tablet , per day, during 30 days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Systemically healthy subjects
- Clinical diagnosis of gingivitis
Key exclusion criteria (6 listed)
- Subjects who had used any systemic antibiotics in the previous 3 months,
- Subjects who had used a product containing probiotics in the previous month
- Systemic disease or condition that could interfere with the study results
- Ongoing drug therapy that could affect the signs of gingivitis
- Subjects who were received periodontal treatment in the last 6 months and
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 |
|---|---|---|
| Synbiotic SupplementAlso: NOBEL (NBL) Probiotic Optima | Drug | Synbiotic supplements |
| Placebo Oral Tablet | Drug | Placebo Oral Tablet |
Primary outcome
Change from Baseline Interleukin (IL)-6 level of GCF at 2 months
Time frame: baseline, 1st and 2nd months
GCF samples were collected with paper strips and IL-6 levels of GCF were measured using commercial kits by using ELISA method
Change from Baseline IL-8 level of GCF at 2 months
Time frame: baseline, 1st and 2nd months
GCF samples were collected with paper strips and IL-8 levels of GCF were measured using commercial kits by using ELISA method
Change from Baseline IL-10 level of GCF at 2 months
Time frame: baseline, 1st and 2nd months
GCF samples were collected with paper strips and IL-10 levels of GCF were measured using commercial kits by using ELISA method
3 secondary outcomes
Change from Baseline GCF volume at 2 months
Time frame: baseline, 1st and 2nd months
Change from Baseline Gingival Index at 2 months
Time frame: baseline, 1st and 2nd months
Change from Baseline Plaque Index at 2 months
Time frame: baseline, 1st and 2nd months
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 6 Mar 2018.
- Individual participant dataSharing planned: Yes. Randomization was performed by one researcher that had never any role in participant's treatment and clinical measurement processes (E.O.E). Patients' all measurements and treatments were made by a single researcher who doesn't know in which group participants were included (N.E.).
Related trials for Gingivitis; Chronic
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Association Between Periodontal Disease and Chronic Neck Pain
Periodontal Disease, Chronic Neck Pain
Not yet recruiting
A Multicentre Randomised Controlled Trial Evaluating the Efficacy of the SMILE™ Module for Improving Short-term Periodontal Outcomes, Compliance, and Acceptability Among Clinical Dental Students
Gingivitis, Gingivitis; Chronic
Not yet recruitingObservational study
Effects of Using Miswak in Addition to Oral Hygiene Products in Patients With Gingivitis
Gingivitis; Chronic
RecruitingObservational study
HALP Score, Blood-Based Inflammatory Indices, and Salivary MMP-8 in Periodontal Disease and Healing After Non-Surgical Therapy
Periodontal Diseases, Periodontitis
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 Synbiotic Supplement in people with Gingivitis; Chronic and Smoking, run by Kırıkkale 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 2 inclusion and 6 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 6 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline Interleukin (IL)-6 level of GCF at 2 months (time frame: baseline, 1st and 2nd months). The study lists 3 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 6 Mar 2018.