NCT05494476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

August 8, 2022

Last Update Submit

August 8, 2022

Conditions

Alveolar Bone LossDental Implant Failure Nos

Keywords

marginal bone lossperi-implant bone remodelingsubmerged dental implant

Outcome Measures

Primary Outcomes (6)

  • marginal bone loss

    radiographic assessment

    at implant insertion

  • marginal bone loss

    radiographic assessment

    5 month after implant insertion

  • marginal bone loss

    radiographic assessment

    6 months after prosthetic loading

  • marginal bone loss

    radiographic assessment

    12 months after prosthetic loading

  • marginal bone loss

    radiographic assessment

    3 years after prosthetic loading

  • marginal bone loss

    radiographic assessment

    5 years after prosthetic loading

Study Arms (2)

2mm under bone level

ACTIVE COMPARATOR

implant platform will be submerged 2mm under bone level

Procedure: implant insertion

1mm under bone level

ACTIVE COMPARATOR

implant platform will be submerged 1mm under bone level

Procedure: implant insertion

Interventions

implant insertionPROCEDURE

after flap detachment, implant bed will be prepared with twist-drill, implant will be inserted according to randomization (1 or 2 mm under bone)

1mm under bone level2mm under bone level

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Claudio Stacchi Office

Gorizia, Friuli Venezia Giulia, 34170, Italy

Location

Related Publications (2)

  • 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.

    PMID: 31033035BACKGROUND

  • 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.

    PMID: 25678247BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Claudio Stacchi, Dr

    Piezoelectric Surgery Academy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: split mouth protocol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 10, 2022

Study Start

October 23, 2020

Primary Completion

December 15, 2021

Study Completion

July 15, 2022

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)