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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06099834
Other study ID # 256
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2018
Est. completion date February 11, 2021

Study information

Verified date November 2023
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date February 11, 2021
Est. primary completion date November 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Patients selection
Patient selection were selected according to selected criteria.
Implnat placement
dental implants were applied as recommended by the manufacturer.
Recall visits
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.

Locations

Country Name City State
Turkey Istanbul Medipol University, School of Dentistry Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary RFA measurement 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 the 1st (T1), 4th (T4), and 12th (T12) weeks
Primary Periotest measurement 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. the 1st (T1), 4th (T4), and 12th (T12) weeks
Secondary Pocket probing depth 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. he 1st (T1), 4th (T4), and 12th (T12) weeks
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