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NCT Number: NCT04662216

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian University of Health Sciences

Kaunas, Kauno, 44307, Lithuania

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scaling and Root Planing

Procedure

Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes).

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

Procedure

Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes), "Perisolv" gel will adjectively be applied to all pockets with probing depth(PD) ≥ 5 mm, 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. Afterwards, all teeth will be polished and all treated pockets will be filled with hyaluronic acid gel (Hyadent BG).

Primary outcomes

  1. Probing depth (PD) reduction

    Time frame: 6 months

    PD (probing depth): the distance (mm) between the gingival margin and the bottom of the sulcus/pocket

Secondary outcomes

  1. Clinical attachment level (CAL)

    Time frame: 6 months

    CAL (clinical attachment level): will be calculated for each site as the sum of PD and the gingival recession/overgrowth.

  2. Bleeding on probing (BOP)

    Time frame: 6 months

    BOP (bleeding on probing): presence (+) or absence (-) of bleeding within 15s after probing the pocket (%).

  3. Plaque Index (PI)

    Time frame: 6 months

    PI (Plaque index): presence of dental plaque along the mucosal margin at 6 sites of the implant presence (+) or absence (-).

  4. Reduction of total counts of periodontopathogenic bacteria

    Time frame: 6 months

    Subgingival plaque samples will be analyzed for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia Treponema denticola and Prevotella intermedia

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 10, 2020
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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