Evaluation of the Effects of Probiotic Toothpastes on Periodontal Health

March 6, 2025 updated by: Berceste Guler, Kutahya Health Sciences University

This controlled, randomized clinical study aims to evaluate the possible effects of probiotic toothpaste on the success of periodontal treatment in smokers and non-smokers with clinical data.

The main question(s) it aims to answer are:

Does applying probiotic toothpaste in addition to periodontal treatment have a positive effect on the gingival of periodontitis patients who are smokers and non-smokers?

The study includes four groups; Group 1: Use of probiotic toothpaste + smoking patient Group 2: Use of regular toothpaste + smoking patient Group 3: Use of probiotic toothpaste + non-smoking patient Group 4: Use of regular toothpaste + non-smoking patient

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Periodontitis is characterized by the progressive destruction of all periodontium structures that support the teeth, including periodontal connective tissue and alveolar bone, caused by dental biofilm, resulting in irreversible damage. Severe periodontitis has become a public health problem that affects approximately 11% of the world's population, that is, 743 million people. When left untreated, it reduces the quality of life and leads to tooth loss. In addition to being a common cause of tooth loss, severe periodontitis has been reported to be a predisposing factor in the development of major systemic diseases such as atherosclerosis, cerebrovascular disease, diabetes, rheumatoid arthritis, Alzheimer's disease and some cancers, and increases the risk of adverse pregnancies (low birth weight, preterm birth). Periodontal inflammation is caused by the presence of gram-negative anaerobic bacteria called "red complex" in the subgingival plaque. Red complex bacteria include Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola, which are responsible for the onset and development of periodontal disease and are found predominantly in the deep periodontal pockets of patients with periodontitis.

In addition, genetic and environmental factors may increase an individual's susceptibility to periodontal disease. The patient's smoking and diabetes mellitus are risk factors for periodontitis. Smoking is the most important environmental risk factor for periodontitis. When subgingival biofilms of nonsmokers/former smokers were compared with smokers, smokers exhibited a higher prevalence of red complex bacteria. Additionally, it has been reported that the potential negative effect of smoking on immune cells, especially neutrophils, makes the individual more susceptible to periodontitis. It has been observed that periodontitis patients who smoke have more alveolar bone and attachment loss than non-smokers. The main goal of periodontal treatment in patients diagnosed with periodontitis is based on removing subgingival biofilm and dental calculus. Before applying surgical periodontal treatment, which is the second step, the first step is non-surgical periodontal treatment and is a prerequisite for deciding to proceed to the surgical stage. In addition to non-surgical periodontal treatment, Local and/or systemic antibiotics, anti-inflammatory drugs, photodynamic therapy, laser, probiotics, prebiotics and synbiotics, statins, ozone therapy, epigenetic therapy, and omega 3-6 can be used. Probiotics modulate the oral microbiota by integrating beneficial bacteria into oral biofilms and preventing the treatment of oral microbial diseases. Probiotics are defined as live microorganisms that provide health benefits when administered in sufficient amounts. The most common probiotic bacteria are Lactobacillus and Bifidobacterium species. Probiotic bifidobacteria have antimicrobial activity against periodontal pathogenic bacteria P. gingivalis and Fusobacterium nucleatum. In an in vitro study by Jasberg et al., it was shown that species belonging to the genus Bifidobacterium could strongly adhere to the subgingival biofilm and significantly reduce the number of Porphyromonas gingivalis. All bifidobacteria integrated well into subgingival biofilms consisting of Porphyromonas gingivalis, Actinomyces naeslundii, and Fusobacterium nucleatum, but only significantly reduced the number of P.gingivalis in biofilms. In the systematic review and meta-analysis evaluating the additional use of probiotics in patients with chronic periodontitis, seven clinical studies evaluating the effectiveness of probiotics as an aid in scaling and root planing were included. While four studies showed additional benefits of probiotics in reducing pocket depth and providing clinical attachment gain, Three studies showed no significant differences. In addition, the difference between the average clinical attachment gain of the patients during the long-term follow-up phases was found to be significant. Today, studies show that probiotic toothpaste effectively prevents infectious diseases such as caries or periodontal disease. However, there are no studies on the effect of smoking on the effectiveness of toothpaste.

Probiotic Toothpaste Content: Glycerin, Hydrated Silica, Aqua, Aloe Barbedensiz, Leaf Juice, Citric Acid, Potassium Sorbate, Sodium Benzoate, Xanthan Gum, B.Coagulans BC4, Xylitol, Sodium Coco-Sulfate, Sodium Hydroxide, Lavandula AngusTifolia (Lavender) Contains Oil (Linalool).

OHIP-14 survey: The effect of the treatment on the patient's quality of life is evaluated with a 14-question survey asked before and one month after non-surgical periodontal treatment.

Periodontal indexes will be taken from all patients in the study group after taking systemic and dental anamnesis. At the first examination session, study samples will be taken, clinical periodontal measurements (plaque index, gingival index, bleeding index, pocket depth, attachment loss, were used to evaluate the periodontal status in 6 regions of each tooth (mesio-buccal, buccal, disto-buccal, disto-palatal, palatal, mesio-palatal) with the Williams periodontal probe (Hu-Friedy, USA) will be measured and recorded) and the oral health effective profile-14 (OHIP-14) questionnaire will be recorded. Afterward, all teeth will be cleaned with an ultrasonic device, and oral hygiene training will be given to the patients. Patients will be taught how to brush their teeth using the modified Bass technique and how to use an interdental brush. In the second session, tooth brushing and interdental brush usage will be checked, and if sufficient, dental floss training will be given; if inadequate, brush usage will be explained again.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kütahya, Turkey, 43100
        • Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Being over 18 years old
  2. Pocket depth ≥ 4 mm and clinical attachment loss ≥ 1 mm in at least 5 teeth, bleeding score on probing 20%, and widespread bone loss that can be diagnosed radiographically.
  3. Absence of any systemic disease
  4. Having at least 14 natural teeth
  5. Diagnosing periodontitis as a result of clinical and radiological examinations
  6. Volunteering to participate in the research and signing the consent form prepared in accordance with the Declaration of Helsinki.

Exclusion Criteria:

  1. Being outside the specified age range
  2. Being pregnant or lactating
  3. Having used antibiotics for any reason in the last 3 months
  4. Having had periodontal treatment in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Use of probiotic toothpaste + smoking patient
Other: Using Probiotic Toothpaste

Scaling and root planing (Phase 1 = non-surgical periodontal treatment) are performed in all patient groups.

Depending on the study groups, regular or probiotic toothpaste will be used. Toothpaste is instructed to be used twice a day
No Intervention: Group 2
Use of regular toothpaste + smoking patient
Experimental: Group 3
Use of probiotic toothpaste + non-smoking patient
Other: Using Probiotic Toothpaste

Scaling and root planing (Phase 1 = non-surgical periodontal treatment) are performed in all patient groups.

Depending on the study groups, regular or probiotic toothpaste will be used. Toothpaste is instructed to be used twice a day
No Intervention: Group 4
Use of regular toothpaste + non-smoking patient

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Periodontal pocket depth changes
Time Frame: 3 month follow up
Periodontal pocket depth changes will be measured with periodontal probe at baseline and third month postoperatively
3 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Berceste Guler Ayyildiz, Kutahya Health Science University
  • Principal Investigator: Ahu Uraz Corekci, Izmir Democracy University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-03/08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If contacted, the principal researcher's evaluation will be shared.

IPD Sharing Time Frame

Six months after the study is completed and published

IPD Sharing Access Criteria

If contacted, the principal researcher's evaluation will be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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