Evaluation of Osseointegration Process of Dental Implants

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06099834
• Other study ID #: 256
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dental Implant Failed
• Osseointegration Failure of Dental Implant

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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