Effects of Polynucleotides and Hyaluronic Acid Based Subgingival Periodontal Pockets Re-instrumentation
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.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2019
CompletedFirst Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedMay 17, 2022
May 1, 2022
1.6 years
January 14, 2022
May 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 months
Study Arms (2)
subgingival re-instrumentation + gel containing PDRN and HA
EXPERIMENTALsubgingival re-instrumentation + gel containing PDRN and HA
subgingival re-instrumentation
ACTIVE COMPARATORsubgingival re-instrumentation
Interventions
subgingival re-instrumentation (control)
Eligibility Criteria
You may qualify if:
- males and females with ≥ 18 years
- stage 3 generalized periodontitis
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome
Rome, 00161, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Pilloni
University of Roma La Sapienza
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman Section of Periodontics Director of Master Program in Periodontics
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 27, 2022
Study Start
February 19, 2018
Primary Completion
September 9, 2019
Study Completion
December 13, 2019
Last Updated
May 17, 2022
Record last verified: 2022-05