A Phase 2 interventional study of Minimally invasive non-surgical therapy and Subgingival application of collagen hydrogels with proanthocyanidins in Periodontitis, Adult, sponsored by Lithuanian University of Health Sciences. Completed at 1 site in Lithuania. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Lithuanian University of Health Sciences · Phase 2, Interventional, and Treatment
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.
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.
386 studies on the registry are indexed under Chronic Periodontitis; 23 are open to participants now.
This study's enrollment of 46 is close to the median of 46 across 314 interventional studies indexed under Chronic Periodontitis.
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Exclusion criteria:
Patients with periodontitis received minimally invasive non-surgical therapy .
Procedure: Minimally invasive non-surgical therapy · Diagnostic Test: Collection of saliva samples
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
Under local anesthesia subgingival instrumentation with ultrasonic and hand instruments and magnification (4.5x) was performed.
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.
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.
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.
Time frame: Before treatment and 8 weeks after baseline
Mean PPD change from baseline in deep sites at 8 week
Pocket probing depth is measured with periodontal probe. Pocket probing depth from gingival margin to the bottom of periodontal pocket.
Time frame: Before treatment and 8 weeks after baseline
Mean CAL changes from baseline at 8 week
Clinical attachment level is measured with periodontal probe.
Time frame: Before treatment and 8 weeks after baseline
Mean PI changes from baseline at 8 week
Presence or absence of plaque is measured.
Time frame: Before treatment and 8 weeks after baseline
Mean BOP change from baseline in deep sites at 8 week
Presence or absence of bleeding during periodontal probing.
Time frame: Before treatment and 8 weeks after baseline
Mean MMP-3, TIMP-1 changes from baseline at 8 week
Biomarkers MMP-3 (matrix metalloproteinase-3) and TIMP-1 (endogenous tissue inhibitors of metalloproteinases-1) concentration in salivary samples.
Time frame: Before treatment and 8 weeks after baseline
Plan to share: No
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