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Efficacy of Proanthocyanidins in Non-Surgical Periodontal Therapy

NCT05015387 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-06-30

No results posted yet for this study

Summary

The aim of the study is to evaluate the efficacy of proanthocyanidins as an adjunctive periodontal therapy in patients with periodontitis. Recently proanthocyanidins were proposed as a viable adjunct to periodontal treatment. Preclinical studies have shown high antibacterial and anti-inflammatory capacities of proanthocyanidins, that could reduce periodontal inflammation and promote periodontal tissues regeneration. In addition, proanthocyanidins demonstrate a specific antibacterial characteristic to attack periodonto-pathogenic bacteria (Porphyromonas gingivalis) but save the oral commensal bacteria (Streptococcus salivarius). Patients with periodontitis (stage III-IV) were included in this study. Patients with periodontitis received two different treatment modalities: minimally invasive non-surgical therapy only (MINST group) or minimally invasive non-surgical therapy and subgingival application of collagen hydrogels with proanthocyanidins (MINST+PACNs group). Clinical periodontal parameters (PPD, CAL, BOP, PI) were evaluated before treatment and after 8 weeks. Concentrations of immunological markers MMP-3 and TIMP-1 in saliva were investigated.

Conditions

  • Periodontitis, Adult

Interventions

PROCEDURE

Minimally invasive non-surgical therapy

Under local anesthesia subgingival instrumentation with ultrasonic and hand instruments and magnification (4.5x) was performed.

COMBINATION_PRODUCT

Subgingival application of collagen hydrogels with proanthocyanidins

Patients received collagen hydrogel chips with proanthocyanidins from Pelargonium sidoides root extract, placed subgingivally in periodontal pockets with PPD≥4mm after minimally invasive non-surgical therapy.

DIAGNOSTIC_TEST

Collection of saliva samples

For MMP-3/TIMP-1 detection, the collection of saliva samples was performed using Salivette (SARSTEDT AG and Co, Germany) saliva sample collection kit. Saliva samples were collected at the baseline for all patients and 8 weeks after treatment. Samples were centrifuged at 3500 rpm (2 min), aliquoted and protease inhibitors cocktail (1 mg/ml) was added to each sample. All samples were stored at -80oC. MMP-3, TIMP-1 concentration in saliva samples was examined using commercial ELISA kits (Elabscience, USA) and Multiskan Microplate Photometer (Thermo Fisher Scientific) at 450 nm wavelength. Saliva MMP-3/TIMP-1 samples were collected before treatment and 8 weeks after treatment.

Sponsors & Collaborators

  • Lithuanian University of Health Sciences

    lead OTHER

Principal Investigators

  • Nijolė Savickienė, PhD · Lithuanian University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2019-04-09
Completion
2019-05-09

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05015387 on ClinicalTrials.gov