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Completed

NCT Number: NCT04657757

Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials

Investigation of bacterial adhesion and bactericide effect ex vivo on different implant restoration materials

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Key information

Conditions

Dental Diseases Dry Socket Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Center for Dentistry Basel UZB

Basel, 4031, Switzerland

About this study

The aim of this study is to investigate bacterial attachment and bactericidal effects of different materials used for the transmucosal part of implants. Using a brace, the intraoral biofilm formation in healthy subjects will be measured after 28 hours (24 hours intraorally, 4 hours rest). For this purpose 2 sterile platelets of each of the 8 differently processed materials (16 platelets in total) are inserted into the braces.

The main target parameter is the quantification of the biofilm by crystal violet staining. For this purpose the samples are analyzed by spectrophotometry at a wavelength of 595 nm (OD595).

As secondary target parameter possible bactericidal effects of the materials, which are analyzed by Colony forming units (CFU) determination, are used.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No systemic antibiotic therapy during the last 3 months
  • Good oral hygiene and compliance (plaque index (PI) <20%, bleeding index (BI) <20%)
  • No signs of periodontitis or other inflammatory changes in surrounding tissues
  • Non-smokers

Exclusion criteria

  • Disease that requires antibiotics
  • Pressure points caused by the braces, which cannot be eliminated by adjusting
  • Other unforeseen complications that can be associated with braces

Treatment and study plan

Intraoral apparatus

Other

Eight platelets with different material composition and surface properties are fastened in a holder (carrier rondell) with 15 mm diameter and inserted into the braces. Braces are to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures. Platelets then are removed and analyzed. After a first course the braces are to be cleaned in chlorhexidine solution in an ultrasonic bath; followed by a second identical course (Braces to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures).

Primary outcomes

  1. quantification of biofilm

    Time frame: 2x 24hours in a period of about 10 days

    quantification of the biofilm by crystal violet staining. For this purpose the samples are analyzed by spectrophotometry at a wavelength of 595 nm (OD595).

Secondary outcomes

  1. number of CFU

    Time frame: 2x 24hours in a period of about 10 days

    Possible bactericidal effects of the materials, which are analyzed by CFU determination, serve as secondary target parameter.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 8, 2020
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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