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Effects of Polynucleotides and Hyaluronic Acid Based Subgingival Periodontal Pockets Re-instrumentation

U

University of Roma La Sapienza

Status

Completed

Conditions

Periodontal Pocket

Treatments

Other: subgingival re-instrumentation

Study type

Interventional

Funder types

Other

Identifiers

NCT05210686
4766 Prot n 947/17

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • males and females with ≥ 18 years
  • stage 3 generalized periodontitis
  • 3-6 months after step 1 and 2 of periodontal treatment, at least two non-adjacent teeth showing one residual pocket with probing depth (PD) ≥5, without mobility and without furcation involvement.

Exclusion criteria

  • full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) >20%
  • inadequate restorative therapy or malocclusion
  • uncontrolled systemic disease
  • immunosuppressive therapy or therapy with corticosteroid or with bisphosphonates
  • inflammatory and autoimmune diseases of the oral cavity
  • history of malignancy, radiation therapy or chemotherapy for malignancy in the last 5 years
  • insulin-dependent diabetes;
  • smoking (> 10 cigarettes per day)
  • drug and alcohol abuse
  • pregnant or lactating.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

subgingival re-instrumentation + gel containing PDRN and HA
Experimental group
Description:
subgingival re-instrumentation + gel containing PDRN and HA
Treatment:
Other: subgingival re-instrumentation
subgingival re-instrumentation
Active Comparator group
Description:
subgingival re-instrumentation
Treatment:
Other: subgingival re-instrumentation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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