Chronic PeriodontitisNCT05408364
Probiotics Effects to Initial Periodontal Treatment
A study testing probiotic or natural yoghurt and SRP in people with Chronic Periodontitis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- probiotic or natural yoghurt and SRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2011to Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- chronic periodontitis patients with radiographically detected horizontal bone loss
- the presence of at least 2 teeth with one approximal site with a probing pocket depth (PPD) of 4≤SD<7 mm (5-7 mm) and a GI of ≥2 mm in each quadrant,
- previously untreated periodontitis, systemically healthy
Who cannot join
- Systemic diseases
- Antibiotics and anti-inflammatory drugs within 3 months before the study
- Untreated caries lesions or local retention factors
- Allergic reactions to lactose or fermented milk products
- Previous probiotic supplements in diet
- Smoking
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Microbiological Evaluation of Probiotics as an Adjunct to Initial Periodontal Treatment in Chronic Periodontitis
The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.
Read the detailed description
The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.
Thirty chronic periodontitis patients were randomized into 2 groups. As adjunctive to MPT, Group 1 consumed 2×108 CFU/day of Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt while Group 2 natural yoghurt once daily for 28 days. Subgingival plaque samples were obtained from 2 periodontal sites with probing pocket depth (PPD) of 4≤PPD<7 mm via paper-points at baseline, 28th day, 3rd month. Samples were cultured to evaluate total viable count (TVC), the proportions of obligate anaerobes (OA) and Bifidobacterium species (B) (TVC%). The full-mouth recorded clinical parameters were plaque index, gingival index, PPD, bleeding on probing, and clinical attachment level.
- Conditions
- Chronic Periodontitis
- Being tested
- probiotic or natural yoghurt, SRP
- Keywords
- bifidobacterium, chronic periodontitis, dental scaling, probiotic, root planing
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic or natural yoghurtDietary supplement
Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt
SRPProcedure or surgery
Scalling and root planing
| Study group | Role | What they receive |
|---|---|---|
| Natural yoghurt | Placebo comparator | SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye) Receives: Dietary Supplement: probiotic or natural yoghurt; Procedure: SRP |
| Probiotic yoghurt | Experimental | SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye) Receives: Dietary Supplement: probiotic or natural yoghurt; Procedure: SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
Measured: 28 days
Secondary outcomes (5)
Gingival Index
Each of the buccal, mesial, lingual and distal surfaces of the gingival tissues is given a score of 0-3. (0 = Normal gingiva. 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation -marked redness and edema.)
Measured: 28 days
Plaque Index
Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. (0 = No plaque in the gingival area. 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. 2 = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. 3 = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. Tendency to spontaneous bleeding.)
Measured: 28 days
Bleeding on probing
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
Measured: 28 days
Clinical attachment level
The distance from the cementoenamel junction to the bottom of the periodontal pocket.
Measured: 28 days
microbiological parameters
The number of obligate anaerobic bacteria and Bifidobacterium anaerobes
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study startApr 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bahar Kuru, Prof. Dr., Study director, Marmara University, Faculty of Dentistry, Department of PeriodontologyHafize Öztürk Özener, Dr., Principal investigator, Marmara University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408364
- Sponsor's protocol ID
- MAR-2011-03-30-24
- Status last verified
- Mar 2011
- First submitted
- 16 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Evaluation of Probiotics as an Adjunct to Initial Periodontal Treatment in Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT05408364
- Acronym / sponsor ID
- MAR-2011-03-30-24
- Conditions
- Chronic Periodontitis
- Keywords
- bifidobacterium, chronic periodontitis, dental scaling, probiotic, root planing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Jun 2022 (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 clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.
Detailed description
The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.
Thirty chronic periodontitis patients were randomized into 2 groups. As adjunctive to MPT, Group 1 consumed 2×108 CFU/day of Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt while Group 2 natural yoghurt once daily for 28 days. Subgingival plaque samples were obtained from 2 periodontal sites with probing pocket depth (PPD) of 4≤PPD<7 mm via paper-points at baseline, 28th day, 3rd month. Samples were cultured to evaluate total viable count (TVC), the proportions of obligate anaerobes (OA) and Bifidobacterium species (B) (TVC%). The full-mouth recorded clinical parameters were plaque index, gingival index, PPD, bleeding on probing, and clinical attachment level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural yoghurt | Placebo comparator | Dietary Supplement: probiotic or natural yoghurt, Procedure: SRPSRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye) |
| Probiotic yoghurt | Experimental | Dietary Supplement: probiotic or natural yoghurt, Procedure: SRPSRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic periodontitis patients with radiographically detected horizontal bone loss
- the presence of at least 2 teeth with one approximal site with a probing pocket depth (PPD) of 4≤SD<7 mm (5-7 mm) and a GI of ≥2 mm in each quadrant,
- previously untreated periodontitis, systemically healthy
Key exclusion criteria (7 listed)
- Systemic diseases
- Antibiotics and anti-inflammatory drugs within 3 months before the study
- Untreated caries lesions or local retention factors
- Allergic reactions to lactose or fermented milk products
- Previous probiotic supplements in diet
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 |
|---|---|---|
| probiotic or natural yoghurtBifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt | Dietary supplement | Natural yoghurt, Probiotic yoghurt |
| SRPScalling and root planing | Procedure or surgery | Natural yoghurt, Probiotic yoghurt |
Primary outcome
Probing Depth
Time frame: 28 days
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
5 secondary outcomes
Gingival Index
Time frame: 28 days
Plaque Index
Time frame: 28 days
Bleeding on probing
Time frame: 28 days
Clinical attachment level
Time frame: 28 days
microbiological parameters
Time frame: 28 days
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 7 Jun 2022.
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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.
Bahar Kuru, Prof. Dr. study director
Marmara University, Faculty of Dentistry, Department of Periodontology
Hafize Öztürk Özener, Dr. principal investigator
Marmara University, Faculty of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic or natural yoghurt and SRP in people with Chronic Periodontitis, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Probing Depth (time frame: 28 days). 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 7 Jun 2022.