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

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Completed
CT.gov ID
NCT05210686
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
21.7
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: subgingival re-instrumentation
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Feb 19, 2018
Actual Primary Completion Date :
Sep 9, 2019
Actual Study Completion Date :
Dec 13, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: subgingival re-instrumentation + gel containing PDRN and HA

subgingival re-instrumentation + gel containing PDRN and HA

Other: subgingival re-instrumentation
subgingival re-instrumentation (control)
Active Comparator: subgingival re-instrumentation

subgingival re-instrumentation

Other: subgingival re-instrumentation
subgingival re-instrumentation (control)

Outcome Measures

Primary Outcome Measures

  1. Pocket depth [12 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome Rome Italy 00161

Sponsors and Collaborators

  • University of Roma La Sapienza

Investigators

  • Principal Investigator: Andrea Pilloni, Sapienza University of Rome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Pilloni MD DDS MS, Chairman Section of Periodontics Director of Master Program in Periodontics, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT05210686
Other Study ID Numbers:
  • 4766 Prot n 947/17
First Posted:
Jan 27, 2022
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Periodontal Pocket

Study Results

No Results Posted as of May 17, 2022