Clinical trial NCT05210686: Effects of Polynucleotides and Hyaluronic Acid Based Subgingival Periodontal Pockets Re-instrumentation
Official title: Clinical and Biochemical Effects of the Adjunctive Use of a Polynucleotides and Hyaluronic Acid Based Gel in the Subgingival Re-instrumentation of Residual Periodontal Pockets: a Randomized, Split-mouth Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Pocket
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pocket depth
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea Pilloni
role: PRINCIPAL_INVESTIGATOR
References: