Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.

December 1, 2022 updated by: Dentsply International

Evaluation of Changes of Hard and Soft Tissues After Epi-crestal and Sub-crestal Placement of Ankylos Dental Implants.

The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.

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 purpose of this study is to test epicrestal and subcrestal placement of dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.

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.
48

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010-4086
        • Bluestone Center for Clinical Research

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects must have read, understood and signed an informed consent form;
  2. Subjects must be 18 to 70 years of age;
  3. Subjects must be able and willing to follow study procedures and instructions;
  4. Subjects must have indication to receive two implants in a bilateral maxillary or mandibular edentulous areas (for at least 4 months post extraction) in areas of pre-molars (first or second) and molars (first or second);
  5. Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant;
  6. Sufficient vertical clearance to place a single tooth crown replacement;
  7. No apical disorder/inflammation at the area of the implant site.

Exclusion Criteria:

  1. Subjects participating in other clinical studies within 1 month prior to screening and/or involving therapeutic intervention (either medical or dental) that could affect bone or soft tissue healing;
  2. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study;
  3. Subjects with parafunctional habits;
  4. Subjects who have failed to maintain good plaque control;
  5. Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery;
  6. Absence of occlusal stability in centric occlusion;
  7. Subjects with the presence of acute infectious lesions in the areas intended for surgery;
  8. History within the last 3 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day)
  9. Present alcohol or drug abuse;
  10. Angulation requirements of the restoration exceeding approximately 15 degrees;
  11. Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration (e.g. calcium channel blocker, dilantin).

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 Assignment
  • 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.
Active Comparator: Epi-crestal implants.
Ankylos dental endosseous implants-Epi-crestal
Device: Ankylos dental endosseous implants-Epi-crestal
Implants placed Epi-crestally
Experimental: Implants placed at sub-crestal position.
Ankylos dental endosseous implants-Sub-crestal
Device: Ankylos dental endosseous implants-Sub-crestal
Implants placed subcrestally

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
Change in Marginal Bone Level (MBL)
Time Frame: Implant placement, and 18 months and 30 months after implant placement

Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations.

Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30.
Implant placement, and 18 months and 30 months after implant placement

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
Change in Mid-Buccal Soft Tissue Height
Time Frame: From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Soft tissue levels were measured clinically from a fixed reference point to the mid buccal soft tissue margin using a stent. Measurements were made from fixed reference points, by using a stent to perform clinical measurements in a reproducible position.
From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Change of Interproximal Levels After Final Restoration
Time Frame: From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement

Analysis of interproximal bone height change measured by periapical radiographs. The height of the papilla will be assessed at the mesial and distal sites of the implants, by means of the published "papilla Jemt index". Measurements will be assessed by reviewing the clinical photographs.

Reference: Jemt, T. (1997) "Regeneration of gingival papillae after single-implant treatment". International Journal of Periodontics and Restorative Dentistry 17: 326-333.
From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Change in Marginal Bone Level (MBL)
Time Frame: Implant placement, and 66 months after implant placement

Changes in MBLs at 66 months after implant placement were chosen as a secondary outcome parameter. Results are described as mean values and standard deviations.

Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18, T30 and T66.
Implant placement, and 66 months after implant placement

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.
Dentsply International

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: Stuart J Froum, DDS, Bluestone Center for Clinical Research

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.

Helpful Links

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.
April 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.
April 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.
April 1, 2019

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).
December 31, 2012

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.
January 2, 2013

First Posted (Estimate)

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.
January 3, 2013

Study Record Updates

Last Update Posted (Estimate)

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.
December 29, 2022

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.
December 1, 2022

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.
December 1, 2022

More Information

Terms related to this study

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.
  • Ankylos-Bluestone

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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