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

NCT ID: NCT04662216

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2022-05-01

Brief 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.

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

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

Scaling and root planing

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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).

test group

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

Group Type: EXPERIMENTAL

Scaling and root planing

Intervention Type: PROCEDURE

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

Interventions

Scaling and root planing

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

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Egle Ramanauskaite

pHd student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vita Machiulskiene, Prof

Role: STUDY_CHAIR

LUHS

Locations

Lithuanian University of Health Sciences

Kaunas, Kauno, Lithuania

Countries

Lithuania

References

Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23.

Reference Type: DERIVED

PMID: 37740107 (View on PubMed)

Other Identifiers

Protocol1, Version2

Identifier Type: -

Identifier Source: org_study_id