# Geno-toxic risk assessment of locally produced bovine pericardium (LYOLEMB) for guided tissue regeneration

## TL;DR

This study shows that a locally produced bovine pericardium material is safe and non-mutagenic for use in periodontal tissue regeneration.

## Contribution

The study provides new evidence on the genotoxic safety of LYOLEMB for guided tissue regeneration in periodontal therapy.

## Key findings

- LYOLEMB showed no significant genotoxicity in the Ames test across tested concentrations.
- Revertant counts remained below twice the control, indicating non-mutagenic properties.
- Results confirm LYOLEMB is biocompatible and safe for periodontal use.

## Abstract

This study evaluated the genotoxic risk of locally produced bovine pericardium (LYOLEMB) as a guided tissue regeneration (GTR)
material for advanced periodontal disease using the Ames test with metabolic activation (a sodium phosphate buffer). Mutagenic effects
on Salmonella typhimurium strains TA 98, TA 1537, TA 100 and TA 1535 at concentrations ranging from 0.3125 mg/plate to 5 mg/plate
showed no significant genotoxicity, with revertant counts remaining below twice that of the control. Statistical significance was
observed near p ≤ 0.05 at certain concentrations, confirming LYOLEMB's non-mutagenic, biocompatible and safe use in periodontal
therapy.