Clinical trial NCT04662216: Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment
Official title: Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: periodontitis
scaling and root planing
sodium hypochlorite
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Probing depth (PD) reduction
timeFrame: 6 months
Secondary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: 6 months
measure: Bleeding on probing (BOP)
timeFrame: 6 months
measure: Plaque Index (PI)
timeFrame: 6 months
measure: Reduction of total counts of periodontopathogenic bacteria
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
state: Kauno
Study officials:
affiliation: LUHS
name: Vita Machiulskiene, Prof
role: STUDY_CHAIR
References: