Efficacy of Proanthocyanidins in Non-Surgical Periodontal Therapy

NCT05015387 | Completed Phase 2

• 1 other identifier: Proanthocyanidins
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean PPD change from baseline in moderate sites at 8 weeks

  Pocket probing depth is measured with periodontal probe. Pocket probing depth from gingival margin to the bottom of periodontal pocket.

  Before treatment and 8 weeks after baseline

Secondary Outcomes (5)

• Mean PPD change from baseline in deep sites at 8 week

  Before treatment and 8 weeks after baseline

• Mean CAL changes from baseline at 8 week

  Before treatment and 8 weeks after baseline

• Mean PI changes from baseline at 8 week

  Before treatment and 8 weeks after baseline

• Mean BOP change from baseline in deep sites at 8 week

  Before treatment and 8 weeks after baseline

• Mean MMP-3, TIMP-1 changes from baseline at 8 week

  Before treatment and 8 weeks after baseline

Study Arms (2)

MINST group

ACTIVE COMPARATOR

Patients with periodontitis received minimally invasive non-surgical therapy .

Procedure: Minimally invasive non-surgical therapy; Diagnostic Test: Collection of saliva samples

MINST+PACNs group

EXPERIMENTAL

Patients with periodontitis received minimally invasive non-surgical therapy and subgingival application of collagen hydrogels with proanthocyanidins.

Procedure: Minimally invasive non-surgical therapy; Combination Product: Subgingival application of collagen hydrogels with proanthocyanidins; Diagnostic Test: Collection of saliva samples

Interventions

Minimally invasive non-surgical therapy PROCEDURE

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

MINST group; MINST+PACNs group

Subgingival application of collagen hydrogels with proanthocyanidins COMBINATION_PRODUCT

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.

MINST+PACNs group

Collection of saliva samples DIAGNOSTIC_TEST

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.

MINST group; MINST+PACNs group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with stage III and IV periodontitis with slow or moderate rate of progression (A/B) (radiographic bone loss extending to middle or apical third of the root, tooth loss due to periodontitis, maximum probing depth≥6mm, horizontal and vertical (≥3mm) bone loss);
• systemically healthy individuals;
• have≥ 20 remaining teeth;
• ≥30 years patients.

You may not qualify if:

• patients with stage I and II periodontitis (radiographic bone loss in coronal third, no tooth loss due to periodontitis, maximum probing depth ≤5mm, mostly horizontal bone loss);
• patients with systemic diseases;
• had antibiotic therapy during the last 3 months;
• had periodontal treatment during last 6 months;
• were pregnant or lactating women;
• claimed to be allergic to the adjunct (proanthocyanidins).

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT-50161, Lithuania

Location

Related Publications (4)

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  PMID: 29926952 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.

  PMID: 20335313 BACKGROUND

• Jekabsone A, Sile I, Cochis A, Makrecka-Kuka M, Laucaityte G, Makarova E, Rimondini L, Bernotiene R, Raudone L, Vedlugaite E, Baniene R, Smalinskiene A, Savickiene N, Dambrova M. Investigation of Antibacterial and Antiinflammatory Activities of Proanthocyanidins from Pelargonium sidoides DC Root Extract. Nutrients. 2019 Nov 19;11(11):2829. doi: 10.3390/nu11112829.

  PMID: 31752295 BACKGROUND

• Savickiene N, Jekabsone A, Raudone L, Abdelgeliel AS, Cochis A, Rimondini L, Makarova E, Grinberga S, Pugovics O, Dambrova M, Pacauskiene IM, Baseviciene N, Viskelis P. Efficacy of Proanthocyanidins from Pelargonium sidoides Root Extract in Reducing P. gingivalis Viability While Preserving Oral Commensal S. salivarius. Materials (Basel). 2018 Aug 22;11(9):1499. doi: 10.3390/ma11091499.

  PMID: 30135370 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Proanthocyanidins

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tannins; Biopolymers; Polymers; Macromolecular Substances

Study Officials

• Nijolė Savickienė, PhD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients were allocated by the Examiner 1. The same examiner performed the coding and randomization of the participants in the treatment groups with a computer-generated randomization table. Both groups received full-mouth minimally invasive non-surgical therapy procedure by single periodontist (Examiner 2), and patients in MINST+PACNs group received collagen hydrogel chips with proanthocyanidins, placed subgingivally in periodontal pockets with PPD≥4mm. After minimally invasive non-surgical therapy patients returned for the next appointment (8 weeks after baseline). Periodontal reevaluation of encoded patients was performed by a single periodontist (Examiner 2).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant

Model Details: All patients were allocated by the same examiner to two groups: the first group received minimally invasive non-surgical therapy only (MINST group), the second group- minimally invasive non-surgical therapy and subgingival application of collagen hydrogels with PACNs (MINST+PACNs group). The same examiner performed the coding and randomization of the participants in the treatment groups with a computer-generated randomization table.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 20, 2021
• Study Start: January 9, 2019
• Primary Completion: April 9, 2019
• Study Completion: May 9, 2019
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)