Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment: a Randomized Controlled Clinical Trial

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    56
  • sponsor
    Lithuanian University of Health Sciences
Updated on 27 January 2021

Summary

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.

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

Details
Condition Periodontitis, Periodontitis
Treatment Scaling and root planing, Scaling and root planing + "Perisolv" +"Hyadent BG" gels
Clinical Study IdentifierNCT04662216
SponsorLithuanian University of Health Sciences
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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