Evaluation of Osseointegration Process of Dental Implants

NCT ID: NCT06099834

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-14

Study Completion Date

2021-02-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Implant Failed Osseointegration Failure of Dental Implant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Patients selection

Intervention Type OTHER

Patient selection were selected according to selected criteria.

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.

Group Type OTHER

Implnat placement

Intervention Type OTHER

dental implants were applied as recommended by the manufacturer.

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.

Group Type OTHER

Recall visits

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patients selection

Patient selection were selected according to selected criteria.

Intervention Type OTHER

Implnat placement

dental implants were applied as recommended by the manufacturer.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nur Balci, DDs, PhD

Associate Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Medipol University, School of Dentistry

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19405177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 356184 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18379449 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

256

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Osteoimplant and Dental Implants Stability
NCT06657521 NOT_YET_RECRUITING EARLY_PHASE1