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

Sponsor

Lithuanian University of Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04662216

Collaborator

(none)

Enrollment

Location

Arms

32.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Procedure: Scaling and root planing Procedure: Scaling and root planing + "Perisolv" +"Hyadent BG" gels	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 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.

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 4, 2019

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Probing depth (PD) reduction [6 months]
PD (probing depth): the distance (mm) between the gingival margin and the bottom of the sulcus/pocket

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lithuanian University of Health Sciences	Kaunas	Kauno	Lithuania	44307

Sponsors and Collaborators

Lithuanian University of Health Sciences

Investigators

Study Chair: Vita Machiulskiene, Prof, LUHS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Egle Ramanauskaite, pHd student, Lithuanian University of Health Sciences

ClinicalTrials.gov Identifier:

NCT04662216

Other Study ID Numbers:

Protocol1, Version2

First Posted:

Dec 10, 2020

Last Update Posted:

Dec 10, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Egle Ramanauskaite, pHd student, Lithuanian University of Health Sciences

periodontitis

scaling and root planing

sodium hypochlorite

Additional relevant MeSH terms:

Periodontitis

Study Results

No Results Posted as of Dec 10, 2020