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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: Scaling and root planing
* Procedure: Scaling and root planing + Perisolv +Hyadent BG gels


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>Scaling and root planing | Procedure: Scaling and root planing + Perisolv +Hyadent BG gels<br>* 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).<br>|
| Experimental: test group<br>scaling and root planing + Perisolv +Hyadent BG gels. | Procedure: Scaling and root planing<br>* Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth (PD) reduction | PD (probing depth): the distance (mm) between the gingival margin and the bottom of the sulcus/pocket | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Bleeding on probing (BOP) | BOP (bleeding on probing): presence (+) or absence (-) of bleeding within 15s after probing the pocket (%). | 6 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, scaling and root planing, sodium hypochlorite