NCT05975138

Brief Summary

two groups of inserted implants: trans-gingival and under-bone level; difference in the marginal bone loss at six months from placement between the two groups of implant positioned in the posterior atrophic maxilla

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 all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

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

June 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

July 26, 2023

Last Update Submit

July 26, 2023

Conditions

Alveolar Bone Resorption

Keywords

bone atrophydental implantbone remodeling

Outcome Measures

Primary Outcomes (1)

  • marginal bone loss

    millimeter of peri-implant bone resorption

    six months

Secondary Outcomes (1)

  • marginal bone loss

    one year

Study Arms (2)

trans-gingival short implants

trans-gingival implant insertion in the posterior atrophic maxilla

Procedure: implant insertion

subcrestal short implants

subcrestal implant insertion in the posterior atrophic maxilla

Procedure: implant insertion

Interventions

implant insertionPROCEDURE

a minimally invasive full-thickness flap will be raised in order to visualize the anatomy of the ridge. The vertical thickness of the supracrestal soft tissue will be measured and recorded. The preparation of the implant site will be performed with rotary burs and the bone quality will be recorded. An implant will be placed according to the manufacturer's recommendations. The length of the implant will be chosen in order to obtain a bicortical anchorage on the floor of the maxillary sinus

Also known as: dental implant positioning
subcrestal short implantstrans-gingival short implants

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people with an edentulous site in the posterior maxilla

You may qualify if:

  • \) indications for an implant-prosthetic rehabilitation of a single edentulism in the upper posterior arch, on the basis of an accurate diagnosis and treatment planning;
  • \) the bone crest must be healed (at least six months after tooth loss);
  • \) residual bone crest width ≥6 mm;
  • \) presence of an available bone height between 4.5 and 8.5 mm on the floor of the maxillary sinus in the area of the planned implant insertion;
  • \) patient age \>18 years;
  • \) the patient must not wear any type of removable prosthesis on the treated area;
  • \) the patient must be able to follow the study protocol;
  • \) written informed consent

You may not qualify if:

  • \) acute myocardial infarction in the last 2 months;
  • \) uncontrolled bleeding disorders;
  • \) uncontrolled diabetes (HBA1c \> 7.5);
  • \) head/neck radiotherapy in the last 24 months;
  • \) immunocompromised patients, HIV positive or undergoing chemotherapy in the last 5 years;
  • \) current or past treatment with intravenous bisphosphonates;
  • \) psychological or psychiatric problems;
  • \) alcohol or drug abuse;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (3)

  • Fan T, Li Y, Deng WW, Wu T, Zhang W. Short Implants (5 to 8 mm) Versus Longer Implants (>8 mm) with Sinus Lifting in Atrophic Posterior Maxilla: A Meta-Analysis of RCTs. Clin Implant Dent Relat Res. 2017 Feb;19(1):207-215. doi: 10.1111/cid.12432. Epub 2016 Jun 13.

    PMID: 27295262BACKGROUND

  • Han HC, Lim HC, Hong JY, Ahn SJ, Han JY, Shin SI, Chung JH, Herr Y, Shin SY. Primary implant stability in a bone model simulating clinical situations for the posterior maxilla: an in vitro study. J Periodontal Implant Sci. 2016 Aug;46(4):254-65. doi: 10.5051/jpis.2016.46.4.254. Epub 2016 Aug 30.

    PMID: 27588215BACKGROUND

  • Mezzomo LA, Miller R, Triches D, Alonso F, Shinkai RS. Meta-analysis of single crowns supported by short (<10 mm) implants in the posterior region. J Clin Periodontol. 2014 Feb;41(2):191-213. doi: 10.1111/jcpe.12180. Epub 2013 Nov 25.

    PMID: 24266703BACKGROUND

Study Officials

  • claudio stacchi, dr

    International Piezoelectric surgery Academy

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 3, 2023

Study Start

June 15, 2021

Primary Completion

June 15, 2023

Study Completion

July 15, 2023

Last Updated

August 3, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

only after data elaboration

Locations

IT(1)