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

Primary Purpose

Periodontal Pocket

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
subgingival re-instrumentation
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

subgingival re-instrumentation + gel containing PDRN and HA

subgingival re-instrumentation

Arm Description

subgingival re-instrumentation + gel containing PDRN and HA

subgingival re-instrumentation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 14, 2022
Last Updated
May 16, 2022
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT05210686
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
December 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
subgingival re-instrumentation + gel containing PDRN and HA
Arm Type
Experimental
Arm Description
subgingival re-instrumentation + gel containing PDRN and HA
Arm Title
subgingival re-instrumentation
Arm Type
Active Comparator
Arm Description
subgingival re-instrumentation
Intervention Type
Other
Intervention Name(s)
subgingival re-instrumentation
Intervention Description
subgingival re-instrumentation (control)
Primary Outcome Measure Information:
Title
Pocket depth
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Pilloni
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome
City
Rome
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

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

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