Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment: a Randomized Controlled Clinical Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Periodontitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + "Perisolv" +"Hyadent BG" gels.Masking: Triple (Care Provider, Investigator, Outcomes Assessor)Masking Description: Periodontal examination, microbiologic sampling and professional oral cleaning will be performed by the investigator, unaware of periodontal treatment. Periodontal treatment will be performed by the investigator, unaware of clinical examination. Microbiological analysis will be performed by a third investigator, masked from clinical measurements and periodontal treatment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 125 years
- Gender
- Both males and females
Description
Objectives: To evaluate if additional subgingival delivery of chloramine and hyaluronic acid gels would enhance clinical outcomes of scaling and root planing in periodontitis patients. To assess if additional subgingival delivery of chloramine and hyaluronic acid gels would reduce total counts of pe...
Objectives: To evaluate if additional subgingival delivery of chloramine and hyaluronic acid gels would enhance clinical outcomes of scaling and root planing in periodontitis patients. To assess if additional subgingival delivery of chloramine and hyaluronic acid gels would reduce total counts of periodontopathogenic bacteria compared to scaling and root planing alone. The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + "Perisolv"+ Hyadent BG gels. The periodontal treatment will be performed in one session without time restrictions. Under local anesthesia, an experienced operator, will perform a full mouth subgingival scaling and root planing with an ultrasonic device and Gracey curettes. Afterwards, all teeth will be polished using a low-abrasive paste. Teeth in the test group (all teeth with PD ? 5 mm) will adjunctively be treated with chloramine gel (Perisolv), which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Teeth will be polished and all treated pockets will be filled with hyaluronic acid gel. Teeth in control group will receive SRP + polishing
Tracking Information
- NCT #
- NCT04662216
- Collaborators
- Not Provided
- Investigators
- Study Chair: Vita Machiulskiene, Prof LUHS
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