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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.
Objectives:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | Scaling and root planing |
|
| test group | Experimental | scaling and root planing + "Perisolv" +"Hyadent BG" gels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and root planing | Procedure | Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes). |
|
| 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 |
| 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 (%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vita Machiulskiene, Prof | LUHS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Kaunas | Kauno | 44307 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37740107 | Derived | 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. |
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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.
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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.
| 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). |
|
| 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 |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
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