Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment

Lithuanian University of Health Sciences

Status: Completed

Conditions: Periodontitis

Treatments: Procedure: Scaling and root planing + "Perisolv" +"Hyadent BG" gels; Procedure: Scaling and root planing

Study type: Interventional

Funder types: Other

Identifiers

NCT04662216

Protocol1, Version2

Details and patient eligibility

About

The aim of the study is to investigate clinical and microbiological effects of subgingival application of chloramine (Perisolv) and hyaluronic acid (Hyadent BG) gels as adjuncts to scaling and root planing in non-surgical periodontitis treatment.

Full description

Objectives:

1. To evaluate if additional subgingival delivery of chloramine and hyaluronic acid gels would enhance clinical outcomes of scaling and root planing in periodontitis patients.
2. 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

Enrollment: 50 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• > 30 years old;
• Good general health according to medical history and clinical judgment;
• Exhibiting at least one pocket in each quadrant with pocket depth (PD) ≥ 5 mm;
• Radiographic evidence of bone loss ( > 2 mm from cemento-enamel junction (CEJ) );
• Untreated periodontal disease;
• Minimum 20 teeth (wisdom teeth excluded);
• No removable prosthesis.

Exclusion criteria

• Patients already included in other clinical trials;
• Periodontal treatment during the last 12 months;
• Antibiotic treatment 6 months prior to the start of the trial;
• Antibiotic prophylaxis required for dental treatment;
• Ongoing medication that may affect the clinical features of periodontitis;
• Pregnant/lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

control group

Active Comparator group

Description:

Scaling and root planing

Treatment:

Procedure: Scaling and root planing + "Perisolv" +"Hyadent BG" gels

test group

Experimental group

Description:

scaling and root planing + "Perisolv" +"Hyadent BG" gels.

Treatment:

Procedure: Scaling and root planing