Genotoxicity Assessment of Dental Implants in Gingival Epithelial Cells

NCT04540991 | Unknown Phase 3

• 1 other identifier: 003-08/20-03/0005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the strong correlation between genotoxicity and carcinogenesis, it is necessary to clarify the potential genotoxic effects of titanium dental implant systems. As most dental materials release small amounts of several elements into the oral cavity, proper regulations have to guarantee that the concern from genotoxicity/mutagenicity of dental materials is annulated or at the lowest possible level. Thus, further biocompatibility records are needed in order to evaluate the comprehensive risks of these compounds. In a view of the above-mentioned data, the aim of this in vivo study is to evaluate genotoxic and cytotoxic potential of implants and gingiva formers from two different implant systems in gingival epithelial cells. Exfoliated gingival cells will be taken from 80 participants before and after 90 days of dental implant insertion, and 21 days following gingiva former placement. DNA damage will be analyzed using the micronucleus test. Tested dental implants will be Ankylos and Dentium, with corresponding gingival former.

Conditions

Genotoxicity

Keywords

implantology; genotoxicity

Outcome Measures

Primary Outcomes (1)

• Cytotoxic and/or genotoxic

  Evaluation of the cytotoxic and genotoxic alterations in gingival epithelial cells after application of titanium-based dental implant system

  1 year

Study Arms (2)

Ankylos dental implant group

ACTIVE COMPARATOR

Patients are divided into two groups depending on the dental implant system used in the therapy. Ankylos dental implants (Dentsplay Sirona, Charlotte, USA) areused in the first group of patients.

Procedure: implant placement; Procedure: gingiva former placement; Diagnostic Test: Collecting gingival epithelial cellsusing the swab technique

Dentium SuperLine implant group

ACTIVE COMPARATOR

Patients are divided into two groups depending on the dental implant system used in the therapy. Dentium SuperLine implants (Dentium Co., Seoul, Korea) is used in the second group of patients-.

Procedure: implant placement; Procedure: gingiva former placement; Diagnostic Test: Collecting gingival epithelial cellsusing the swab technique

Interventions

implant placement PROCEDURE

The implants are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.

Ankylos dental implant group; Dentium SuperLine implant group

gingiva former placement PROCEDURE

Gingiva former are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures of oppeninf implant cower and gingiva former placement on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.

Ankylos dental implant group; Dentium SuperLine implant group

Collecting gingival epithelial cellsusing the swab technique DIAGNOSTIC_TEST

Samples of gingival epithelial cells are collected from each participant's implementation site using the swab technique at three different time points: a control swab is taken just before the placement of the dental implant (T0); the second swab is taken 90 days after implantation meaning immediately before placement of the gingiva former (T1); and the third swab is taken 21 days after placement of the gingiva former (T2).

Ankylos dental implant group; Dentium SuperLine implant group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• absence of a single tooth in the mandibular molar or premolar region
• belonging to ASA I or ASA II group
• absence of titanium hypersensitivity
• absence of prosthetic restoration/replacement or orthodontic appliances in the oral cavity, -absence of oral precancerous lesions
• no history of radiation in the head and neck area
• absence of bisphosphonates and corticosteroids used in therapy.

You may not qualify if:

• presence of systemic disease (e.g. uncontrolled diabetes, oral mucosal diseases, untreated gingivitis and periodontitis, endodontic lesions)
• pocket depths ≥ 4 mm on adjacent teeth
• bruxism
• poor oral hygiene
• pregnant and lactating women
• taking of antibiotics in the last three months
• taking any other pharmaceutics that have been proved to elevate DNA damage,
• underwent medical radiation diagnostics
• using mouthwash that contain alcohol
• history of radiation in the head and neck area.

Sponsors & Collaborators

• Daniel Jerković: lead

Study Sites (1)

School of Medicine, University of Split

Split, 21000, Croatia

Location

Related Publications (22)

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Study Officials

• Daniel Jerkovic, DMD

  University of Split, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DMD

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 7, 2020
• Study Start: March 10, 2020
• Primary Completion: March 20, 2021
• Study Completion: April 25, 2022
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

CR (1)