Stability of the Marginal Bone Around Subcrestal Implants

August 8, 2022 updated by: International Piezosurgery Academy

Stability of the Marginal Bone Around Subcrestal Implants Inserted at Different Depths. A Multicenter Clinical Study

The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining their long-term success. Apico-coronal position represents a crucial factor in this field. This study aims to establish the optimal insertion depth of a subcrestal implant, with the aim of minimizing the bone resorption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining their long-term success.

In reality, the etiology of this bone remodeling (Marginal Bone Loss-MBL) has not yet been well understood, although many theories have been proposed to explain it.

The influence of mucosal thickness on marginal bone loss has been discussed by Cochran et al., which suggest a protective action for the underlying soft tissue bone that recreates a sort of "biological width" around the implant. In fact, some studies have hypothesized that a marginal bone loss> 2.0 mm provides the vertical space for the correct restoration of biological width. Linkevicius et al. have published various studies that have shown that, in crestally placed implants with switching platform, a vertical thickness of the soft tissues greater than 2 mm is effective in preventing the loss of peri-implant marginal bone. However, other authors have demonstrated significant marginal bone loss around implants with low prosthetic abutments compared to those with higher prosthetic abutments. In particular, the extent of bone loss was more reduced when the height of the abutment was> 2 mm. From a theoretical point of view, a 3 mm high prosthetic abutment, calculated from the apical edge of the crown to the implant platform, should provide adequate space for restoring biological width.

Furthermore, a recent study conducted on subcrestal implants has shown that early marginal bone resorption, in addition to being linked to the thickness of the soft tissues and the height of the abutment, is negatively influenced by the depth of implant insertion. However, the same study underlines that implants inserted more deeply, while losing more marginal bone than more superficial implants, are covered by a greater bone thickness at the end of the remodeling process.

This study aims to establish the optimal insertion depth of a subcrestal implant, with the aim of minimizing the resorption of the marginal bone and keeping the implant platform below the bone level after 12 months of prosthetic loading.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • 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

  • Italy
    • Friuli Venezia Giulia
      • Gorizia, Friuli Venezia Giulia, Italy, 34170
        • Dr. Claudio Stacchi Office

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indications for the insertion of two implants in a free edentulous ridge in the posterior area of both arches (premolar / molar area), based on a careful diagnosis and treatment plan;
  • presence of a residual bone crest with a minimum surgical height of 9 mm, and a thickness of at least 6 mm at the level of the planned implant sites;
  • the bone crest must be healed (at least 6 months after tooth loss / extraction of the corresponding dental element);
  • native bone;
  • plaque index below 25% and bleeding index below 20%;
  • facial-lingual width of the adherent gingiva ≥ 4 mm;
  • age of the patient> 18 years;
  • patients must be able to review and understand the study protocol;
  • informed consent.

Exclusion Criteria:

  • acute myocardial infarction within the last 6 months;
  • uncompensated coagulation disorders;
  • uncontrolled diabetes (HbA1c> 7.5%);
  • head / neck radiotherapy in the last 24 months;
  • immunocompromised patients (HIV infection or chemotherapy within the last 5 years);
  • present or past treatment with antiresorptive drugs;
  • psychological or psychiatric problems;
  • alcohol or drug abuse;
  • presence of uncontrolled periodontal disease
  • acute and chronic endodontic infections next to implant site.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2mm under bone level
implant platform will be submerged 2mm under bone level
Procedure: implant insertion
after flap detachment, implant bed will be prepared with twist-drill, implant will be inserted according to randomization (1 or 2 mm under bone)
Active Comparator: 1mm under bone level
implant platform will be submerged 1mm under bone level
Procedure: implant insertion
after flap detachment, implant bed will be prepared with twist-drill, implant will be inserted according to randomization (1 or 2 mm under bone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
marginal bone loss
Time Frame: at implant insertion
radiographic assessment
at implant insertion
marginal bone loss
Time Frame: 5 month after implant insertion
radiographic assessment
5 month after implant insertion
marginal bone loss
Time Frame: 6 months after prosthetic loading
radiographic assessment
6 months after prosthetic loading
marginal bone loss
Time Frame: 12 months after prosthetic loading
radiographic assessment
12 months after prosthetic loading
marginal bone loss
Time Frame: 3 years after prosthetic loading
radiographic assessment
3 years after prosthetic loading
marginal bone loss
Time Frame: 5 years after prosthetic loading
radiographic assessment
5 years after prosthetic loading

Collaborators and Investigators

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

Sponsor

International Piezosurgery Academy

Collaborators

University of Trieste

Investigators

  • Study Director: Claudio Stacchi, Dr, Piezoelectric Surgery Academy

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)

October 23, 2020

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEGADEPTH

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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