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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662216
• Other study ID #: Protocol1, Version2
• Status: Completed
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2022
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas	Kauno

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth (PD) reduction	PD (probing depth): the distance (mm) between the gingival margin and the bottom of the sulcus/pocket	6 months
Secondary	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
Secondary	Bleeding on probing (BOP)	BOP (bleeding on probing): presence (+) or absence (-) of bleeding within 15s after probing the pocket (%).	6 months
Secondary	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
Secondary	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