Clinical trial
The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis
Name
CukurovaU-PerII
Description
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.
Trial arms
Trial start
2022-04-01
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Recruiting
Treatment
active chlorhexidine and placebo probiotic
the randomized patients will be receive active chlorhexidine rinse and placebo probiotic
Arms:
Active Chx
placebo chlorhexidine and active probiotic
the randomized patients will receive placebo chlorhexidine rinse and active probiotic
Arms:
Active probiotics
active chlorhexidine and active probiotic
the randomized patients will receive active chlorhexidine rinse and active probiotic
Arms:
Active Chx & probiotics
Size
90
Primary endpoint
percentage of patients in low risk for disease progression
6 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-09-01
1 organization
3 products
3 indications
Organization
Cukurova UniversityProduct
Active chlorhexidineIndication
periodontitisIndication
chlorhexidineIndication
Probiotic