The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis

NCT ID: NCT05548361

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-12-01

Brief Summary

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The aim of this study is determining the additional effect of a 2-week home usage of chlorhexidine in periodontitis patients undergoing scaling and root planing supplemented with a dual-strain probiotic lozenge.

Detailed Description

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Conditions

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Periodontitis Chlorhexidine Probiotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Chx

This group will receive active chlorhexidine and placebo probiotics

Group Type EXPERIMENTAL

active chlorhexidine and placebo probiotic

Intervention Type COMBINATION_PRODUCT

the randomized patients will be receive active chlorhexidine rinse and placebo probiotic

Active probiotics

This group will receive placeo chlorhexidine and active probiotics

Group Type EXPERIMENTAL

placebo chlorhexidine and active probiotic

Intervention Type COMBINATION_PRODUCT

the randomized patients will receive placebo chlorhexidine rinse and active probiotic

Active Chx & probiotics

This group will receive active chlorhexidine and active probiotics

Group Type EXPERIMENTAL

active chlorhexidine and active probiotic

Intervention Type COMBINATION_PRODUCT

the randomized patients will receive active chlorhexidine rinse and active probiotic

Interventions

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active chlorhexidine and placebo probiotic

the randomized patients will be receive active chlorhexidine rinse and placebo probiotic

Intervention Type COMBINATION_PRODUCT

placebo chlorhexidine and active probiotic

the randomized patients will receive placebo chlorhexidine rinse and active probiotic

Intervention Type COMBINATION_PRODUCT

active chlorhexidine and active probiotic

the randomized patients will receive active chlorhexidine rinse and active probiotic

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with generalized (\>30% of teeth affected) periodontitisstage III and IV periodontitis, grade B or C (C only with smoker modifier) = generalized chronic periodontitis including smokers
* A minimum of three natural teeth in each quadrant, excluding third molars
* Willing and able to give informed consent
* Not more than 50% of the patients in each group will be smokers.
* Smokers should smoke between 10 to 40 cigarettes a day

Exclusion Criteria

* Patients with localized periodontitis or periodontitis stage I or II or grade A or grade C or grade C with diabetes modifier
* Patients with orthodontic appliances (removable or fixed)
* Pregnant or lactating woman
* Patients with a history of systemic diseases that may correlate with periodontal health, such as diabetesrheumatic fever, liver or kidney disease, and neurological deficiencies
* Patients taking medication which may affect the periodontium (bisphosphonates, phenytoin, cyclosporin, nifidepine, chronic use of non-steroidal anti-inflammatory drugs)
* Patient who had taken systemic antibiotics up to 3 months prior to treatment or medical conditions requiring prophylactic antibiotic coverage
* Participation in any other clinical study
* Tobacco chewing or sniffing
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioGaia AB

INDUSTRY

Sponsor Role collaborator

Sunstar

UNKNOWN

Sponsor Role collaborator

Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Ozcan

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cukurova university Faculty of Dentistry

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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CukurovaU-PerII

Identifier Type: -

Identifier Source: org_study_id

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