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

NCT05548361 | Completed

• 1 other identifier: CukurovaU-PerII
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Chlorhexidine; Probiotic

Outcome Measures

Primary Outcomes (1)

• probing pocket depth

  the distance between gingival margin and pocket base in millimeters

  6 months

Secondary Outcomes (5)

• percentage of patients in low risk for disease progression

  6 months

• gingival recession

  6 months

• clinical attachment level

  6 months

• full mouth bleeding and plaque score

  6 months

• microbial outcomes

  6 months

Study Arms (3)

Active Chx

EXPERIMENTAL

This group will receive active chlorhexidine and placebo probiotics

Combination Product: active chlorhexidine and placebo probiotic

Active probiotics

EXPERIMENTAL

This group will receive placeo chlorhexidine and active probiotics

Combination Product: placebo chlorhexidine and active probiotic

Active Chx & probiotics

EXPERIMENTAL

This group will receive active chlorhexidine and active probiotics

Combination Product: active chlorhexidine and active probiotic

Interventions

active chlorhexidine and placebo probiotic COMBINATION_PRODUCT

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

Active Chx

placebo chlorhexidine and active probiotic COMBINATION_PRODUCT

the randomized patients will receive placebo chlorhexidine rinse and active probiotic

Active probiotics

active chlorhexidine and active probiotic COMBINATION_PRODUCT

the randomized patients will receive active chlorhexidine rinse and active probiotic

Active Chx & probiotics

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead
• BioGaia AB: collaborator
• Sunstar: collaborator

Study Sites (1)

Cukurova university Faculty of Dentistry

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 21, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

TU (1)