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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Scaling and root planing + "Perisolv" +"Hyadent BG" gels; Procedure: Scaling and root planing

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kauno
    • Kaunas, Kauno, Lithuania, 44307
      • Lithuanian University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; Scaling and root planing	Procedure: Scaling and root planing + "Perisolv" +"Hyadent BG" gels; 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).
Experimental: test group; scaling and root planing + "Perisolv" +"Hyadent BG" gels.	Procedure: Scaling and root planing; Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth (PD) reduction	PD (probing depth): the distance (mm) between the gingival margin and the bottom of the sulcus/pocket	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level (CAL)	CAL (clinical attachment level): will be calculated for each site as the sum of PD and the gingival recession/overgrowth.	6 months
Bleeding on probing (BOP)	BOP (bleeding on probing): presence (+) or absence (-) of bleeding within 15s after probing the pocket (%).	6 months
Plaque Index (PI)	PI (Plaque index): presence of dental plaque along the mucosal margin at 6 sites of the implant presence (+) or absence (-).	6 months
Reduction of total counts of periodontopathogenic bacteria	Subgingival plaque samples will be analyzed for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia Treponema denticola and Prevotella intermedia	6 months

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Study Chair: Vita Machiulskiene, Prof, LUHS

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: periodontitis; sodium hypochlorite; scaling and root planing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: Protocol1, Version2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No