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

• Status: Completed
• Trial end date: 2021-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Malaya
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents

Criteria

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.