Stability of the Marginal Bone Around Subcrestal Implants
Primary Purpose
Alveolar Bone Loss, Dental Implant Failure Nos
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
implant insertion
Sponsored by
About this trial
This is an interventional prevention trial for Alveolar Bone Loss focused on measuring marginal bone loss, peri-implant bone remodeling, submerged dental implant
Eligibility Criteria
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.
Sites / Locations
- Dr. Claudio Stacchi Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2mm under bone level
1mm under bone level
Arm Description
implant platform will be submerged 2mm under bone level
implant platform will be submerged 1mm under bone level
Outcomes
Primary Outcome Measures
marginal bone loss
radiographic assessment
marginal bone loss
radiographic assessment
marginal bone loss
radiographic assessment
marginal bone loss
radiographic assessment
marginal bone loss
radiographic assessment
marginal bone loss
radiographic assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT05494476
First Posted
August 8, 2022
Last Updated
August 8, 2022
Sponsor
International Piezosurgery Academy
Collaborators
University of Trieste
1. Study Identification
Unique Protocol Identification Number
NCT05494476
Brief Title
Stability of the Marginal Bone Around Subcrestal Implants
Official Title
Stability of the Marginal Bone Around Subcrestal Implants Inserted at Different Depths. A Multicenter Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Piezosurgery Academy
Collaborators
University of Trieste
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Dental Implant Failure Nos
Keywords
marginal bone loss, peri-implant bone remodeling, submerged dental implant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split mouth protocol
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2mm under bone level
Arm Type
Active Comparator
Arm Description
implant platform will be submerged 2mm under bone level
Arm Title
1mm under bone level
Arm Type
Active Comparator
Arm Description
implant platform will be submerged 1mm under bone level
Intervention Type
Procedure
Intervention Name(s)
implant insertion
Intervention Description
after flap detachment, implant bed will be prepared with twist-drill, implant will be inserted according to randomization (1 or 2 mm under bone)
Primary Outcome Measure Information:
Title
marginal bone loss
Description
radiographic assessment
Time Frame
at implant insertion
Title
marginal bone loss
Description
radiographic assessment
Time Frame
5 month after implant insertion
Title
marginal bone loss
Description
radiographic assessment
Time Frame
6 months after prosthetic loading
Title
marginal bone loss
Description
radiographic assessment
Time Frame
12 months after prosthetic loading
Title
marginal bone loss
Description
radiographic assessment
Time Frame
3 years after prosthetic loading
Title
marginal bone loss
Description
radiographic assessment
Time Frame
5 years after prosthetic loading
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Stacchi, Dr
Organizational Affiliation
Piezoelectric Surgery Academy
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Claudio Stacchi Office
City
Gorizia
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
34170
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31033035
Citation
Spinato S, Stacchi C, Lombardi T, Bernardello F, Messina M, Zaffe D. Biological width establishment around dental implants is influenced by abutment height irrespective of vertical mucosal thickness: A cluster randomized controlled trial. Clin Oral Implants Res. 2019 Jul;30(7):649-659. doi: 10.1111/clr.13450. Epub 2019 May 12.
Results Reference
background
PubMed Identifier
25678247
Citation
Galindo-Moreno P, Leon-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11.
Results Reference
background
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Stability of the Marginal Bone Around Subcrestal Implants
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