An Early Phase 1 interventional study of 0.85% synthetic antimicrobial peptide TAPS-18 and 0.9% normal saline in Periodontitis, sponsored by University of Malaya. Completed at 1 site in Malaysia. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by University of Malaya · Early Phase 1, Interventional, and Treatment
Background and objective(s): Periodontitis is initiated by a dysbiotic host-microbe relationship. Standard periodontal treatment involves oral hygiene education, mechanical debridement and periodic follow-ups with the aims of pocket closure and maintaining a symbiotic microbial community. Nonetheless, this therapy alone may fail due to the limitations of mechanical instrumentation. The use of antimicrobial in combination to subgingival debridement has been proposed for initial and recurrent periodontitis to enhance the effectiveness of mechanical instrumentation. Antimicrobial peptide (AMP) comprised of a wide range of peptide, was found naturally in various life forms or manufactured as a synthetic compound. This study was conducted to evaluate the use of AMP as an adjunct to non-surgical periodontal treatment in terms of clinical and microbiological outcomes.
Hypothesis
study design: This was a split-mouth randomised pilot study of a 3-months follow-up.
Sample size calculation: The sample size was calculated using G*Power software version 3.1.9.4 (Franz Faul, Universitat Kiel, Germany). Estimation of sample size was based on the mean and standard deviation of CAL between the test and control group of previous publication (Singh et al., 2018). Four samples in each group (test and control) were required to achieve 80% power at a significant level of 5%.
Randomisation: The random allocation sequence was generated by another person who was not directly involved in the study using a Research Randomizer tools (https://www.randomizer.org/). Periodontal sites of each patient were randomised at a split mouth level (left or right halves of the dentition) to one of the two treatment groups. Allocated treatments were inserted into an opaque envelop. Treatment allocation was concealed from the clinician and only revealed once subgingival debridement was completed.
intervention: At baseline, clinical measurement was recorded and target sites (sites with PPD ≥6mm) were identified. subgingival plaque were collected at target sites. The same clinician performed full mouth scaling and subgingival debridement, coupled with standardised oral hygiene instruction for all subjects. Upon the completion of treatment, second clinician applied the treatments according to the randomisation.
Test and control intervention will be repeated for another 2 applications at an interval of 3 days. Subjects were re-examined and plaque sampling will be repeated at 6 weeks and 12 weeks.
statistical analysis: Clinical parameters were reported as mean and standard deviation. P-value \<0.05 was considered statistically significant. intergroup and intragroup comparison of mean bleeding score, pocket depth, clinical attachment level will be conducted using SPSS software. For the metagenomic data, alpha and beta diversity were computed using QIIME 2. The difference in the relative abundance of individual genus over time will be analysed.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 4 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.
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Subject diagnosed with generalised periodontitis Stage III of any grade (Caton et al., 2018).
Exclusion Criteria:
Received subgingival scaling in the previous 6 months.
Half of the dentition will receive scaling and root surface debridement within a week followed by the application of antimicrobial peptide gel Ace Helper™ into the site with pocket depth \>5mm until overflow noticed. Antimicrobial peptide (AMP) will be reapplied for 2 more times at an interval of 3 days. Antimicrobial peptide gel Ace Helper™ contained 0.85% synthetic AMP (TAPS-18) designed based on the basic structure of cathelicidin, hydroxyethyl cellulose, and purified water.
Drug: 0.85% synthetic antimicrobial peptide TAPS-18
Half of the dentition will receive scaling and root surface debridement within a week followed by the irrigation of 0.9% normal saline into the site with pocket depth \>5mm. Normal saline irrigation will be repeated for 2 more times at an interval of 3 days.
Drug: 0.9% normal saline
commercially available synthetic antimicrobial peptide gel for periodontal disease treatment
Also known as: antimicrobial peptide gel Ace Helper™
commercially available normal saline Sodium Chloride irrigation solution
Also known as: RinsCap Normal Saline Sodium Chloride Irrigation Solution
clinical measurement of pocket depth (mm)
changes in pocket depth after the test and control intervention. pocket depth is measured from the gingival margin to base of pocket using UNC-15 probe
Time frame: 6 weeks and 12 weeks
clinical measurement of clinical attachment level (mm)
changes in clinical attachment level after the test and control intervention. clinical attachment level is measured from cemento-enamel junction to base of pocket using UNC-15 probe.
Time frame: 6 weeks and 12 weeks
metagenomic analysis of the relative abundance (%) of bacterial from subgingival plaque
changes in relative abundance of bacterial after the test and control intervention is measured by the metagenomic analysis using subgingival plaque
Time frame: 6 weeks and 12 weeks
Plan to share: No
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University of Malaya