NCT05125718

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

Completed EARLY_PHASE1 Last updated 18 November 2021

What this trial tests

EARLY_PHASE1 trial testing 0.85% synthetic antimicrobial peptide TAPS-18 in Periodontitis in 4 participants. Completed in 30 April 2021.

Timeline

1 January 2021

Primary endpoint
30 April 2021

30 April 2021

Quick facts

Lead sponsor	University of Malaya
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	4
Start date	1 January 2021
Primary completion	30 April 2021
Estimated completion	30 April 2021
Sites	1 location across Malaysia

Drugs / interventions tested

• 0.85% synthetic antimicrobial peptide TAPS-18 — full drug profile →
• 0.9% normal saline

Conditions studied

• Periodontitis — all drugs for Periodontitis →

Sponsor

University of Malaya

Who can join

21 and older, any sex, with Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Applications and Anticancer Effects of Antimicrobial Peptides: From Bench to Bedside.
   Jafari A, Babajani A, Sarrami Forooshani R, Yazdani M, et al · · 2022 · cited 55× · PMID 35280755 · DOI 10.3389/fonc.2022.819563
2. Advanced delivery systems for peptide antibiotics.
   Cesaro A, Lin S, Pardi N, de la Fuente-Nunez C. · · 2023 · cited 35× · PMID 36804008 · DOI 10.1016/j.addr.2023.114733