- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06099834
Evaluation of Osseointegration Process of Dental Implants
November 2, 2023 updated by: Nur Balci, DDs, PhD, Istanbul Medipol University Hospital
Evaluation of Osseointegration Process of Implants With Different Length And Diameter By Different Methods
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34083
- Istanbul Medipol University, School of Dentistry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patient selection
Patient selection criteria were as follows: absence of any systemic disease; not being in American Society of Anesthesiologists (ASA) Class 3 or 4 according to the ASA Physical Status Classification System (Doyle, 2017); being older than 20 years of age; 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.
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Patient selection were selected according to selected criteria.
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Other: Dental Implant Application
Bredent SKY® dental implants were applied at a torque level of 30 N.cm as recommended by the manufacturer.
The surgery and all measurements were performed by the same surgeon.
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dental implants were applied as recommended by the manufacturer.
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Other: Osseointegration and periodontal measurements
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.
In accordance with the manufacturers' recommendations, the final implant stability quotient (ISQ) and Periotest values were determined by calculating the average of three measurements per implant.
At the same time, periodontal index values of probing depth (PD-mm) and bleeding on probing (BOP-%) were recorded at the site of the dental implant at T4 and T12.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RFA measurement
Time Frame: the 1st (T1), 4th (T4), and 12th (T12) weeks
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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
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the 1st (T1), 4th (T4), and 12th (T12) weeks
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Periotest measurement
Time Frame: the 1st (T1), 4th (T4), and 12th (T12) weeks
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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.
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the 1st (T1), 4th (T4), and 12th (T12) weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pocket probing depth
Time Frame: he 1st (T1), 4th (T4), and 12th (T12) weeks
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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.
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he 1st (T1), 4th (T4), and 12th (T12) weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available.
- Abrahamsson I, Linder E, Lang NP. Implant stability in relation to osseointegration: an experimental study in the Labrador dog. Clin Oral Implants Res. 2009 Mar;20(3):313-8. doi: 10.1111/j.1600-0501.2008.01646.x.
- Boronat Lopez A, Balaguer Martinez J, Lamas Pelayo J, Carrillo Garcia C, Penarrocha Diago M. Resonance frequency analysis of dental implant stability during the healing period. Med Oral Patol Oral Cir Bucal. 2008 Apr 1;13(4):E244-7.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2018
Primary Completion (Actual)
November 7, 2020
Study Completion (Actual)
February 11, 2021
Study Registration Dates
First Submitted
October 20, 2023
First Submitted That Met QC Criteria
October 20, 2023
First Posted (Actual)
October 25, 2023
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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