The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability

January 11, 2020 updated by: Jakub Hadzik

The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability - 36 Months Clinical Study

The aim of the study was to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and the loss of the surrounding marginal bone, and whether short implants can be used instead of sinus augmentation procedures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The patients participating in the study (n=30) had one single tooth implant - a short (OsseoSpeed™ L6Ø4 mm, Implants) or a regular implant (OsseoSpeed™ L11 and L13Ø4 mm, DENTSPLY Implants) - placed in the maxilla. The evaluation was based on clinical and radiological examination.

The crown-to-implant ratio was determined by dividing the length of the crown together with the abutment by the length of the implant placed crestally. Mean crown-to-implant ratios were calculated separately for each group and its correlation with the MBL (marginal bone loss) and stability was assessed. The authors compared the correlation between the C/I ratio values, MBL and secondary implant stability.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-smoking patients with no systemic or local diseases were qualified.

Additional inclusion criteria were as follows:

  • minimal apicocoronal height of the alveolar ridge of 6 mm in the region of the implant insertion in the pre-surgical qualification
  • minimal width of the alveolar ridge of 6-7 mm in the region of interest
  • HKT (height of the keratinized tissue) higher than 2 mm
  • API ≤ 35 (Approximal Plaque Index)
  • PI ≤ 25. (Plaque Index)
  • Bone Type III or D2 were included in the study
  • No graft procedures in the area of interest,

Exclusion Criteria:

-

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Short implants Treatment
Group 2 (G2; n=15 patients) had short implants (OsseoSpeed ™ L6mm Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed without sinus lift and augmentation procedure.
Other: Short implants Treatment
Short implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.
ACTIVE_COMPARATOR: Regular Implants Treatment
Group 1 (G1; n=15 patients) had conventional dental implants (OsseoSpeed ™ L11 Ø4 mm and L13 Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed, preceded by the sinus lift procedure from a lateral window approach with the application of the xenogeneic bone graft Geistlich Bio-Oss® [Geistlich AG, Wolhusen, Switzerland]. The lateral window approach sinus lift surgery was performed 6 weeks prior to the implant placement by the same surgeon.
Other: Regular implants Treatment
Sinus lift procedure is done and regular implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical measurement of implant stability
Time Frame: 36 months
Evaluation of implant secondary stability in both groups. Stability measured and evaluated with Periotest(R) device - after 36 months.
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiological measurement of marginal bone loss around implant
Time Frame: 36 months
Evalation if there is difference in marginal bone level around the implants in both groups. Periapical radiographs and CBCT images taken and the begining and at the end of the observation period will be compared and bone level will be measured. Loss of marginal bone will be calculated.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jakub Hadzik

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wrocław Medical University
Dentsply Sirona Implants and Consumables

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marzena Dominiak, Prof, Medical University Wrocław

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • crown-implant ratio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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