- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05015387
Efficacy of Proanthocyanidins in Non-Surgical Periodontal Therapy
Efficacy of Proanthocyanidins in Non-Surgical Periodontal Therapy: a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Ethical permission was issued by the Regional Biomedical Research Ethics Committee (No. BE-2-38). All included patients must have signed an informed consent form, were willing and able to show up for follow-up appointments and agreed to coded data collection. Patients were given enough time to analyze protocol of the study and were free to exit the study at any time without a specific reason. The study was performed according to CONSORT guidelines for randomized controlled clinical trials.
Patients with periodontitis (stage III-IV) were included in the study. The inclusion criteria in treatment groups were systemically healthy 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).
All patients were allocated by the Examiner 1 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 1 performed the coding and randomization of the participants in the treatment groups with a computer-generated randomization table.
Clinical trial protocol included several appointments. At the baseline all patients received periodontal examination by periodontist (Examiner 2), the collection of saliva samples was performed. Both groups received full-mouth minimally invasive non-surgical therapy procedure by single periodontist (Examiner 2). During the MINST procedure the periodontist (Examiner 2) was not informed about the patient 's assignment to the group (MINST or MINST+PACNs). After the procedure patient 's allocation to the group was revealed to periodontist by Examiner 1 and accordingly the patient received adjunctive treatment (in MINST+PACNs group received collagen hydrogel chips with proanthocyanidins) or ended the procedure without adjunctive therapy (MINST group). Postoperative care instructions were given (no flossing or use of chemical control materials).
After the procedure patients returned for the next appointment (8 weeks after baseline). Periodontal reevaluation of encoded patients was performed by a single periodontist (Examiner 2). Saliva sample were collected in the same manner as mentioned before.
The relationship of clinical periodontal parameters and MMP-3 and TIMP-1 levels were analyzed to assess the efficacy of proanthocyanidins in periodontal therapy.
The statistical analysis was performed with IBM SPSS 28 (Armonk, NY: IBM Corp.) statistic software package. Shapiro-Wilk test was performed to assess if clinical periodontal measures (per-patient PPD, CAL, BOP and PI) and biochemical measures (MMP-3 and TIMP-1 concentrations in saliva) followed a normal distribution. Accordingly, if the data followed a normal distribution, paired-samples t-test was done to obtain before and after treatment comparisons within the groups. If the assumption of normality was violated, related samples Wilcoxon signed ranks test was done to obtain before and after treatment comparisons within the groups. The between group comparisons of measures were determined by either independent samples t-test in case the specific measure followed a normal distribution or Mann-Whitney test in case the specific measure followed a non-normal distribution. The statistical significance level was considered at the 0.05 level.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Kaunas, Lithuania, LT-50161
- Lithuanian University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: MINST group
Patients with periodontitis received minimally invasive non-surgical therapy .
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Under local anesthesia subgingival instrumentation with ultrasonic and hand instruments and magnification (4.5x) was performed.
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.
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EXPERIMENTAL: MINST+PACNs group
Patients with periodontitis received minimally invasive non-surgical therapy and subgingival application of collagen hydrogels with proanthocyanidins.
|
Under local anesthesia subgingival instrumentation with ultrasonic and hand instruments and magnification (4.5x) was performed.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean PPD change from baseline in moderate sites at 8 weeks
Time Frame: Before treatment and 8 weeks after baseline
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Pocket probing depth is measured with periodontal probe.
Pocket probing depth from gingival margin to the bottom of periodontal pocket.
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Before treatment and 8 weeks after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean PPD change from baseline in deep sites at 8 week
Time Frame: Before treatment and 8 weeks after baseline
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Pocket probing depth is measured with periodontal probe.
Pocket probing depth from gingival margin to the bottom of periodontal pocket.
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Before treatment and 8 weeks after baseline
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Mean CAL changes from baseline at 8 week
Time Frame: Before treatment and 8 weeks after baseline
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Clinical attachment level is measured with periodontal probe.
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Before treatment and 8 weeks after baseline
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Mean PI changes from baseline at 8 week
Time Frame: Before treatment and 8 weeks after baseline
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Presence or absence of plaque is measured.
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Before treatment and 8 weeks after baseline
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Mean BOP change from baseline in deep sites at 8 week
Time Frame: Before treatment and 8 weeks after baseline
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Presence or absence of bleeding during periodontal probing.
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Before treatment and 8 weeks after baseline
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Mean MMP-3, TIMP-1 changes from baseline at 8 week
Time Frame: Before treatment and 8 weeks after baseline
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Biomarkers MMP-3 (matrix metalloproteinase-3) and TIMP-1 (endogenous tissue inhibitors of metalloproteinases-1) concentration in salivary samples.
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Before treatment and 8 weeks after baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Nijolė Savickienė, PhD, Lithuanian University of Health Sciences
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: J Periodontol. 2018 Dec;89(12):1475.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Proanthocyanidins
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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