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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2019-12-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Periodontal Pocket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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subgingival re-instrumentation + gel containing PDRN and HA

Group Type EXPERIMENTAL

subgingival re-instrumentation

Intervention Type OTHER

subgingival re-instrumentation (control)

subgingival re-instrumentation

Group Type ACTIVE_COMPARATOR

subgingival re-instrumentation

Intervention Type OTHER

subgingival re-instrumentation (control)

Interventions

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subgingival re-instrumentation

subgingival re-instrumentation (control)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes