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

NCT04662216 | Completed DMC

• 1 other identifier: Protocol1, Version2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

periodontitis; scaling and root planing; sodium hypochlorite

Outcome Measures

Primary Outcomes (1)

• Probing depth (PD) reduction

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

  6 months

Secondary Outcomes (4)

• Clinical attachment level (CAL)

  6 months

• Bleeding on probing (BOP)

  6 months

• Plaque Index (PI)

  6 months

• Reduction of total counts of periodontopathogenic bacteria

  6 months

Study Arms (2)

control group

ACTIVE COMPARATOR

Scaling and root planing

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

test group

EXPERIMENTAL

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

Procedure: Scaling and root planing

Interventions

Scaling and root planing PROCEDURE

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

test group

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).

control group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Kauno, 44307, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 37740107 DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Vita Machiulskiene, Prof

  LUHS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Periodontal examination, microbiologic sampling and professional oral cleaning will be performed by the investigator, unaware of periodontal treatment. Periodontal treatment will be performed by the investigator, unaware of clinical examination. Microbiological analysis will be performed by a third investigator, masked from clinical measurements and periodontal treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pHd student

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: October 4, 2019
• Primary Completion: October 1, 2021
• Study Completion: May 1, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)