Microbiome Analysis of Dental Biofilm on High-Density Polytetrafluoroethylene Membranes Used in Socket Preservation

NCT06694844 | Completed

• 1 other identifier: 2170/29-02/1-20-2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate how different types of high-density polytetrafluoroethylene (d-PTFE) membranes impact dental biofilm accumulation and composition in patients undergoing socket preservation following tooth extraction. The main question it aims to answer are: Does the type of d-PTFE membrane influence the diversity and composition of the dental biofilm in vivo? Therefore, the investigators will compare two types of d-PTFE membranes (Permamem® and Cytoplast™) to examine their respective effects on microbial colonization. Participants will:

• Undergo tooth extraction followed by socket preservation with either the Permamem® or Cytoplast™ membrane, randomly assigned.
• Have biofilm samples collected from the membranes after 4 weeks for analysis through SEM, RT-PCR, and NGS methods.
• Return for follow-up visits, including a six-month check to evaluate healing progress and to continue with implant-prosthetics rehabilitation.

Conditions

Microbiology; Alveolar Ridge Preservation; Infections, Bacterial

Keywords

alveolar ridge preservation; non-resorbable membrane; guided bone regeneration; microbiology; dental biofilm; SEM; Next Generation Sequencing; RT-PCR

Outcome Measures

Primary Outcomes (3)

• Scanning electron microscopy analaysis (SEM)

  Description: High-resolution imaging to visualize biofilm morphology and bacterial distribution on the membrane surfaces. Unit of Measure: Qualitative (e.g., bacterial morphology, density). Time Frame: Up to 6 months. This provides an observational outcome focused on the visual and qualitative analysis of biofilm structure.

  Up to 6 months

• RT-PCR

  Description: Quantitative analysis of specific bacterial species' presence and relative abundance associated with dental biofilm on d-PTFE membranes. Unit of Measure: Relative abundance (%) of targeted bacterial species. Time Frame: Up to 8 months. This measure captures the presence and amount of particular bacteria in biofilm samples.

  Up to 8 months

• Next Generation Sequencing (NGS)

  Description: Assessment of microbial diversity, richness, and specific bacterial composition on two types of d-PTFE membranes after a four-week healing period. Unit of Measure: Diversity indices (e.g., Shannon Index, species richness). Time Frame: Up to 10 months. This measure assesses the overall microbial community composition and diversity on each type of membrane.

  Up to 10 months

Study Arms (2)

M1 - permamem + bone grafting

EXPERIMENTAL

M1: In the group M1, the grafted site was covered with a d-PTFE membrane (Permamem®, botiss biomaterials GmbH, Zossen, Germany)

Procedure: Socket preservation with M1

M2 - Cytoplast + bonegrafting

ACTIVE COMPARATOR

• M2: In the group M2 the site was covered with an alternative d-PTFE membrane (Cytoplast™, Osteogenics Biomedical, Texas, USA)

Procedure: Socket preservation with M2

Interventions

Socket preservation with M1 PROCEDURE

Following extraction, socket will be filled with the combination of bovine xenograft and autograft and then covered with d-PTFE M1 membrane (peramem membrane).

M1 - permamem + bone grafting

Socket preservation with M2 PROCEDURE

Following extraction, socket will be filled with the combination of bovine xenograft and autograft and then covered with d-PTFE M2 membrane (Cytoplast membrane).

M2 - Cytoplast + bonegrafting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients indicated for tooth extraction due to:
• Deep caries lesions with chronic periapical periodontitis
• Fractures of the tooth crown and/or root
• Other conditions preventing conventional therapy
• Age between 18 and 60 years
• Physically and mentally healthy
• Patients who understand the study protocol and provide informed consent

You may not qualify if:

• Patients with any absolute contraindications for implant-prosthetic therapy (e.g., uncontrolled systemic diseases)
• Systemic conditions including:
• Uncontrolled diabetes
• Osteoporosis or osteopenia
• Vitamin D deficiency
• Patients on bisphosphonate or long-term glucocorticoid therapy
• Hypothyroidism
• Uncontrolled cardiovascular diseases (e.g., hypertension, coronary artery disease, congestive heart failure)
• Pregnant and lactating women
• Local factors:
• Tobacco users (more than 10 cigarettes per day)
• Poor oral hygiene
• Patients with untreated periodontal disease
• History of radiation in the head and neck area

Sponsors & Collaborators

• Marija Čandrlić: lead
• University of Rijeka, Medical Faculty: collaborator
• Clinical Hospital Center Rijeka: collaborator

Study Sites (1)

University of Rijeka, Faculty of Medicine Rijeka

Rijeka, Croatia

Location

Related Publications (1)

• Begic G, Badovinac IJ, Karleusa L, Kralik K, Cvijanovic Peloza O, Kuis D, Gobin I. Streptococcus salivarius as an Important Factor in Dental Biofilm Homeostasis: Influence on Streptococcus mutans and Aggregatibacter actinomycetemcomitans in Mixed Biofilm. Int J Mol Sci. 2023 Apr 14;24(8):7249. doi: 10.3390/ijms24087249.

  PMID: 37108414 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Olga Cvijanovic Peloza, Full Professor, PhD

  University of Rijeka, Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty of Dental Medicine and Health

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 19, 2024
• Study Start: November 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 1, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Around first quartal od 2025 to the end of 2028.
• Access Criteria: Only academic stuff

Locations

CR (1)