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

NCT05125718 | Completed Early Phase 1

• 1 other identifier: AMP-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  6 weeks and 12 weeks

Study Arms (2)

test group (antimicrobial peptide)

EXPERIMENTAL

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

control group (normal saline)

SHAM COMPARATOR

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

Interventions

0.85% synthetic antimicrobial peptide TAPS-18 DRUG

commercially available synthetic antimicrobial peptide gel for periodontal disease treatment

Also known as: antimicrobial peptide gel Ace Helper™

test group (antimicrobial peptide)

0.9% normal saline DRUG

commercially available normal saline Sodium Chloride irrigation solution

Also known as: RinsCap Normal Saline Sodium Chloride Irrigation Solution

control group (normal saline)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject diagnosed with generalised periodontitis Stage III of any grade (Caton et al., 2018).
• 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.

You may not qualify if:

• Received subgingival scaling in the previous 6 months.
• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

faculty of dentistry, University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hooi Shan

  faculty of dentistry, University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: blinding of subject and clinician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: split-mouth study

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 18, 2021
• Study Start: January 1, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)