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Study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. Residual pockets ≥4mm with positive bleeding or such >5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. Re-evaluations at 3 and 9 months controlled for clinical parameters such as Periodontal Probing Depth (PPD) (CAL), Clinical Attachment Level, Gingival Recession (GR), Bleeding on Probing (BOP). The hypothesis is, sites treated with adjunctive protocol show greater PPD reduction and greater CAL gain at 9-month evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Test arm, patients undergo subgingival instrumentation of residual active site together with an adjunctive treatment protocol. |
|
| Group B | Placebo Comparator | Control arm, patients undergo subgingival instrumentation of residual active site only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subgingival instrumentation plus Perisolv / hyaDent BG | Biological | Group A: Perisolv is applied prior to subgingival instrumentation for disinfecting purpose, hyaDent BG seals the site for accelerated blood clot stabilisation and support of cell proliferation. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Attachment Level | Greater amount of CAL gain in the test group A vs. control group B anticipated | 9 month post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Periodontal Probing Depth | Greater reduction in PPD for group A vs. Group B anticipated | 9 months post-op |
| Gingival Recession | Similar change in the GR depth anticipated for both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Implantat Competence Centrum München | Munich | 80333 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37740107 | Result | 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. | |
| 38676852 |
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| ID | Term |
|---|---|
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| subgingival instrumentation | Procedure | Group B: sites requiring re-treatment are subjected to subgingival scaling |
|
| 9 months post-op |
| Bleeding on Probing | greater reduction in BOP anticipated for group A vs. group B patients. | 9 months post-op |
| Shirakata Y, Nakamura T, Setoguchi F, Imafuji T, Shinohara Y, Matsumura S, Iwata M, Noguchi K, Ramanauskaite E, Sculean A. Histological evaluation of nonsurgical periodontal treatment with and without the use of sodium hypochlorite / amino acids and cross-linked hyaluronic acid gels in dogs. Clin Oral Investig. 2024 Apr 27;28(5):281. doi: 10.1007/s00784-024-05674-7. |
| 39235513 | Derived | Benyei L, Friedmann A, Ostermann T, Diehl D. Non-surgical treatment of residual periodontal pockets using sodium hypochlorite/amino acid gel and cross-linked hyaluronic acid-a 9-month pilot randomized controlled clinical trial. Clin Oral Investig. 2024 Sep 5;28(9):513. doi: 10.1007/s00784-024-05906-w. |