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Completed

NCT Number: NCT06099834

Evaluation of Osseointegration Process of Dental Implants

Implant stability is critical to successful osseointegration, the direct structural connection between the dental implant surface and bone. Implant stability must therefore be measured to evaluate implant success. The study evaluated the osseointegration of different sizes with two devices measuring stability with different methods.

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Key information

Conditions

Dental Implant Failed Osseointegration Failure of Dental Implant

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University, School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

About this study

The 39 implants, 4.0 and 4.5 mm in diameter and 10 and 12 mm in length, in 19 patients were included. Hounsfield unit (HU) values obtained on cone beam computed tomography (CBCT) were recorded. Stabilities were measured with Periotest and resonance frequency analysis (RFA) at day 0 (intra-operative) and the 1st (T1), 4th (T4), and 12th (T12) weeks. Probing depth (PD) and bleeding on probing (BOP) scores were compared between T1 and T4.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Absence of any systemic disease
  • being older than 20 years of age
  • having partial tooth deficiency in the posterior region of the lower jaw (molar tooth deficiency)
  • having an indication for dental implant-supported fixed prosthesis
  • at least 6 months had elapsed since the last tooth extraction in the area to be implanted
  • having a soft tissue thickness of at least 1.5 mm and adherent gingival width of at least 2 mm
  • the existence of panoramic and dental volumetric tomography images of the area to be implanted
  • the presence of a suitable recipient bone for implantation with dental implants of the desired length and diameter
  • completion of periodontal treatment and provision of oral hygiene training; and acceptable existing gingival health and oral hygiene for implant application (periodontally healthy) in the oral examinations performed following periodontal treatment.

Exclusion criteria

  • being in American Society of Anesthesiologists (ASA) Class 3 or 4 according to the ASA Physical Status Classification System

Treatment and study plan

Patients selection

Other

Patient selection were selected according to selected criteria.

Implnat placement

Other

dental implants were applied as recommended by the manufacturer.

Recall visits

Other

Following the operations, the stability of the dental implants was measured at the 1st (T1), 4th (T4), and 12th (T12) weeks using Periotest (Periotest M, Modautal/Germany) and Osstell (Osstell AB-W&H, Sweden) devices.

Primary outcomes

  1. RFA measurement

    Time frame: the 1st (T1), 4th (T4), and 12th (T12) weeks

    two SmartPeg transducers were used on each implant, and three measurements were completed: therefore, total number of registers was six for each implant. All assessment was carried out consecutively regardless register time or location. Measurements were completed by one only experienced dentist with knowl- edge of the Osstell ISQ system for RFA assessment

  2. Periotest measurement

    Time frame: the 1st (T1), 4th (T4), and 12th (T12) weeks

    The periotest device is placed in a horizontal position 0.6-2 mm away from the tooth surface and two PTVs (PTV1 and PTV2) were calculated with a time difference of 20 min. During each measurement, the device delivers 16 impacts in 4 s to the object.

Secondary outcomes

  1. Pocket probing depth

    Time frame: he 1st (T1), 4th (T4), and 12th (T12) weeks

    Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Evaluation of Osseointegration Process of Implants With Different Length And Diameter By Different Methods

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 25, 2023
Registry last updated
Nov 7, 2023

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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