NCT06099834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

October 20, 2023

Last Update Submit

November 2, 2023

Conditions

Dental Implant FailedOsseointegration Failure of Dental Implant

Keywords

osseointegrationdental implantmobility

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Pocket probing depth

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

Study Arms (3)

Patient selection

OTHER

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.

Other: Patients selection

Dental Implant Application

OTHER

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.

Other: Implnat placement

Osseointegration and periodontal measurements

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. 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.

Other: Recall visits

Interventions

Patients selectionOTHER

Patient selection were selected according to selected criteria.

Patient selection
Implnat placementOTHER

dental implants were applied as recommended by the manufacturer.

Dental Implant Application
Recall visitsOTHER

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.

Osseointegration and periodontal measurements

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

Related 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.

    PMID: 19405177BACKGROUND

  • 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.

    PMID: 356184BACKGROUND

  • 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.

    PMID: 18379449BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof Dr

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 25, 2023

Study Start

September 14, 2018

Primary Completion

November 7, 2020

Study Completion

February 11, 2021

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations

TU(1)