Clinical and Metagenomic Investigation of Antimicrobial Peptide Gel in Periodontal Treatment.
NCT ID: NCT05125718
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
4 participants
INTERVENTIONAL
2021-01-01
2021-04-30
Brief Summary
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Hypothesis
• There are changes in clinical periodontal parameters and subgingival microbial profile following treatment with locally delivered synthetic AMP.
Detailed Description
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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 group: Subgingival instrumentation followed by Antimcrobial peptide gel (AMP) application in all target sites.
* Control group: Subgingival instrumentation and normal saline irrigation in all target sites.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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test group (antimicrobial peptide)
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.
0.85% synthetic antimicrobial peptide TAPS-18
commercially available synthetic antimicrobial peptide gel for periodontal disease treatment
control group (normal saline)
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.
0.9% normal saline
commercially available normal saline Sodium Chloride irrigation solution
Interventions
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0.85% synthetic antimicrobial peptide TAPS-18
commercially available synthetic antimicrobial peptide gel for periodontal disease treatment
0.9% normal saline
commercially available normal saline Sodium Chloride irrigation solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥21 years old.
* Subject is in good general health without any remarkable past history of disease except for well controlled diabetes (HbA1c ≤6.5%) (Clinical practice guidelines on management of type 2 diabetes mellitus., 2020).
* Presence of at least 20 teeth.
* Presence of at least 2 non-adjacent sites located in contralateral quadrant with interproximal probing pocket depth (PPD) ≥6mm.
Exclusion Criteria
* Use of antibiotic in the past 6 months.
* Taking steroidal and non-steroidal anti-inflammatory agents on a daily basis.
* Medical condition requiring antibiotic prophylaxis.
* Pregnancy or lactating.
* Smoking ≥10 cigarettes per day.
21 Years
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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Dr. Tan Hooi Shan
Principal Investigator
Principal Investigators
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Hooi Shan
Role: PRINCIPAL_INVESTIGATOR
faculty of dentistry, University of Malaya
Locations
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faculty of dentistry, University of Malaya
Kuala Lumpur, , Malaysia
Countries
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Other Identifiers
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AMP-01
Identifier Type: -
Identifier Source: org_study_id