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

NCT06694844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-11-19

No results posted yet for this study

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

Interventions

PROCEDURE

Socket preservation with M1

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

PROCEDURE

Socket preservation with M2

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

Sponsors & Collaborators

  • University of Rijeka, Medical Faculty

    collaborator UNKNOWN

  • Clinical Hospital Center Rijeka

    collaborator OTHER

  • Marija Čandrlić

    lead OTHER

Principal Investigators

  • Olga Cvijanovic Peloza, Full Professor, PhD · University of Rijeka, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-10-31
Completion
2024-11-01

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06694844 on ClinicalTrials.gov