Evaluation of the Effects of Probiotic Toothpastes on Periodontal Health

NCT06514664 | Enrolling By Invitation

• 1 other identifier: 2023-03/08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Diseases; Periodontitis; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Periodontal pocket depth changes

  Periodontal pocket depth changes will be measured with periodontal probe at baseline and third month postoperatively

  3 month follow up

Study Arms (4)

Group 1

EXPERIMENTAL

Use of probiotic toothpaste + smoking patient

Other: Using Probiotic Toothpaste

Group 2

NO INTERVENTION

Use of regular toothpaste + smoking patient

Group 3

EXPERIMENTAL

Use of probiotic toothpaste + non-smoking patient

Other: Using Probiotic Toothpaste

Group 4

NO INTERVENTION

Use of regular toothpaste + non-smoking patient

Interventions

Using Probiotic Toothpaste OTHER

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

Group 1; Group 3

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years old
• 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.
• Absence of any systemic disease
• Having at least 14 natural teeth
• Diagnosing periodontitis as a result of clinical and radiological examinations
• Volunteering to participate in the research and signing the consent form prepared in accordance with the Declaration of Helsinki.

You may not qualify if:

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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Berceste Guler Ayyildiz

  Kutahya Health Science University

  PRINCIPAL INVESTIGATOR

• Ahu Uraz Corekci

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Dr.

Model Details: Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 23, 2024
• Study Start: April 10, 2023
• Primary Completion: September 10, 2025
• Study Completion: December 10, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Six months after the study is completed and published
• Access Criteria: If contacted, the principal researcher's evaluation will be shared.

Locations

TU (1)