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Clinical and Metagenomic Investigation of Antimicrobial Peptide Gel in Periodontal Treatment.

NCT05125718 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-11-18

No results posted yet for this study

Summary

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

• There are changes in clinical periodontal parameters and subgingival microbial profile following treatment with locally delivered synthetic AMP.

Conditions

  • Periodontitis

Interventions

DRUG

0.85% synthetic antimicrobial peptide TAPS-18

commercially available synthetic antimicrobial peptide gel for periodontal disease treatment

DRUG

0.9% normal saline

commercially available normal saline Sodium Chloride irrigation solution

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Hooi Shan · faculty of dentistry, University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125718 on ClinicalTrials.gov