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Evaluation of Osseointegration Process of Dental Implants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06099834
Enrollment
19
Registered
2023-10-25
Start date
2018-09-14
Completion date
2021-02-11
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant Failed, Osseointegration Failure of Dental Implant

Keywords

osseointegration, dental implant, mobility

Brief summary

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.

Detailed description

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.

Interventions

Patient selection were selected according to selected criteria.

OTHERImplnat placement

dental implants were applied as recommended by the manufacturer.

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.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
RFA measurementthe 1st (T1), 4th (T4), and 12th (T12) weekstwo 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
Periotest measurementthe 1st (T1), 4th (T4), and 12th (T12) weeksThe 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

MeasureTime frameDescription
Pocket probing depthhe 1st (T1), 4th (T4), and 12th (T12) weeksMeasurement 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026