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

Not Applicable

Completed

• Conditions: Periodontal Pocket
• Interventions: Other: subgingival re-instrumentation

• Registration Number: NCT05210686
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2018-02-19
• Primary Completion: 2019-09-09
• Study Completion: 2019-12-13
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subgingival re-instrumentation + gel containing PDRN and HA	subgingival re-instrumentation	subgingival re-instrumentation + gel containing PDRN and HA
subgingival re-instrumentation	subgingival re-instrumentation	subgingival re-instrumentation

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome; 🇮🇹 Rome, Italy