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The purpose of this randomized controlled clinical trial (RCT) was to investigate the clinical and biochemical efficacy of a gel containing PDRN and HA used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.
The aim of the present study was to investigate the clinical and biochemical efficacy of a gel containing polynucleotides (PDRN) and hyaluronic acid (HA) used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.
50 patients were enrolled in a randomized, split-mouth clinical trial. For each patient, two teeth with similar residual pockets with probing depth (PD) ≥ 5 mm were selected to receive re-instrumentation with (test) or without (control) the adjunctive use of a PDRN and HA based gel. Differences in changes of PD, gingival recession (REC), clinical attachment level (CAL), modified sulcular bleeding index (mSBI), plaque index (PLI) from baseline to 6, 8, 24, 36 and 48 weeks were analyzed and the frequencies of sites with PD <4 mm at 48 weeks were compared. Furthermore, changes in the dosage of alpha-2-macroglobulin (α2M) and of matrix metalloproteinase-9 (MMP-9) from baseline to 6 weeks were evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subgingival re-instrumentation + gel containing PDRN and HA | Experimental | subgingival re-instrumentation + gel containing PDRN and HA |
|
| subgingival re-instrumentation | Active Comparator | subgingival re-instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subgingival re-instrumentation | Other | subgingival re-instrumentation (control) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pocket depth | Clinical evaluations were performed by a blind calibrated examiner, different from the investigator who performed the treatment. At baseline (visit 1) and at 6 (visit 2), 8(visit 3), 24 (visit 4), 36 (visit 5) and 48 (visit 6) weeks using a periodontal probe | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Pilloni | University of Roma La Sapienza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome | Rome | 00161 | Italy |
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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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