The Effect of Platform-Matching Versus Platform-Switching Dental Implants on Peri-implant Hard and Soft Tissue Healing

September 8, 2020 updated by: Henry Greenwell, University of Louisville

The Effect of Platform-Matching Versus Platform-Switching Using Standard Internal Versus Tapered Internal Plus Dental Implants on Peri-implant Hard and Soft Tissue Healing

To compare platform-switched implants to platform-matched implants for replacement of a single missing tooth and their effect on: 1) Interproximal alveolar crest level in relation to implant platform. 2) Buccal implant recession. 3) Presence or absence of black triangle apical to the contact point. 4) Implant Success. 5) Adequate buccal tissue thickness.

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

Thirty patients will have a dental implant placed. Fifteen patients will be randomly selected by a coin toss to receive a platform-switched implant while the other fifteen will receive platform-matched implant. Each patient will receive a diagnostic work-up including standardized radiographs (periapicals), study casts, clinical photographs, and a clinical examination of teeth adjacent to the edentulous sites. Pre-surgical preparation will include detailed oral hygiene instructions. Baseline data will be collected at initial exam, and at 2, 4, 6, and 12 months. Parameters measured will include: plaque index, gingival index, probing depth, keratinized tissue, bleeding on probing, and digital radiographic examination. Pre-surgical measurements will include: cemento-enamel junction to osseous crest on adjacent teeth by direct measurement at surgery, and by radiograph at baseline, 2, 4, 6, and 12 months, periodontal form, periodontal biotype, tooth shape, and papilla harmony. Patients will be randomly selected for treatment group assignment using a coin toss before surgery by the mentor. One investigator who is unaware of group assignment will perform all baseline examinations and all follow-up examinations. Means and standard deviations will be calculated for all parameters. A paired t-test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups. A sample size of 15 gives 80% statistical power to detect a difference of 0.5 mm of implant bone loss between groups. All surgical procedures will be completed by one operator under the direction of one mentor. Pre-surgical measurements will be taken first. Local anesthesia will be administered. The surgical procedure will consist of the reflection of full thickness flaps to expose the alveolar crest. The implant platform will be placed 3 to 4 mm apical to the mid-facial gingival margin using dental implant osteotomy drills for preparation of the site. The surgical procedures will be documented with clinical photographs. Sutures will be used to close the flap and bury the implant under the tissue. Records will be kept of healing periodically for the first 8 weeks, then at 4, 6 and 12 months. The test group will use a BioHorizons Tapered Internal Plus "platform-switched" implant. The control group will be BioHorizons standard Internal "platform-matched" implant. All patients will be seen at 1-2, 4, 6 and 8 weeks to monitor healing. At week 8 the implant will be uncovered surgically and provisionalized, and at the 4 month visit the final crown will be placed. Subsequent examinations will take place at 6 and 12 months. Post-surgically, patients will take an antibiotic (doxycycline hyclate 100 mg once a day for two weeks), an analgesic (Vicodin ES every 4-6 hours as needed for pain), and an anti-inflammatory agent (Naproxen 375mg every 12 hours for one week). At post-operative visits plaque removal, and oral hygiene instruction, as needed, will be performed along with clinical photographs and standardized radiographs as scheduled. The results of this study will allow comparison of peri-implant soft and hard tissue healing following placement of a BioHorizons "platform-switched" Tapered Internal Plus implant versus a standard Internal "platform-matched" implant in terms of the effect on marginal bone loss, buccal recession, and papilla fill.

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.
24

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
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

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 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Have one edentulous site bordered by 2 teeth.
  • 2. Healthy persons at least 18 years old.
  • 3. Understands and has signed the informed consent.

Exclusion Criteria:

  • 1. Patients with uncontrolled diabetes, immune disease, or systemic disease that significantly affects the periodontium.
  • 2. Previous head and neck radiation.
  • 3. Patients who have been on IV bisphosphonates or oral bisphosphonates for > 3 years.
  • 4. Smokers.
  • 5. Patients who need prophylactic antibiotics prior to dental procedures.
  • 6. Patients with allergy to any medication or material used in the study.
  • 7. Chemotherapy in the previous 12 months.
  • 8. Severe psychological problems.
  • 9. Patients unable to sign the informed consent.
  • 10. Pregnant patients.
  • 11. History of allergy to common dentifrice ingredients.

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.
ACTIVE_COMPARATOR: Platform-matched dental implant
Platform-matched dental implant placement to measure marginal bone loss, gingival margin position, and papilla fill.
Procedure: Platform-matched dental implant
A platform-matched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.
EXPERIMENTAL: Platform-switched dental implant
Platform-switched dental implant placement to measure marginal bone loss, gingival margin position, and papilla fill.
Procedure: Platform-switched dental implant
A platform-switched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.

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
Marginal alveolar bone loss
Time Frame: 12-months post dental implant placement
Bone loss will be measured radiographically using a stent
12-months post dental 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
Buccal implant recession
Time Frame: 12-months post dental implant placement
Buccal implant recession will be measured using a North Carolina probe using the adjacent teeth and incisal edge of the crown
12-months post dental implant placement
Papilla fill
Time Frame: 12-months post dental implant placement
Presence or absence of black triangle apical to the contact point
12-months post dental implant placement
Buccal soft tissue thickness around implant
Time Frame: 12-months post dental implant placement
Thickness will be measured with an endodontic file using a rubber stopper (objective measure of tissue thickness by penetrating tissue and measuring the thickness in mm).
12-months post dental 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.
University of Louisville

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 12, 2016

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.
July 21, 2017

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.
July 21, 2017

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).
August 28, 2015

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.
August 28, 2015

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.
September 1, 2015

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.
September 10, 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.
September 8, 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.
September 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.
  • 15.0448

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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