NCT03290729

Brief Summary

This study was designed as a multicentric prospective clinical trial to assess the clinical, biological and patient's perceived success of new wedge-shaped dental implants inserted in narrow ridges.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

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

May 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

2.5 years

First QC Date

July 21, 2017

Last Update Submit

August 25, 2020

Conditions

Alveolar Bone Loss

Keywords

wedge implants; atrophic bone

Outcome Measures

Primary Outcomes (1)

  • implant survival rate

    health of the inserted implants

    1 year after surgery

Secondary Outcomes (12)

  • surgical procedure evaluation

    during surgery

  • surgical procedure evaluation

    1 hour after surgery

  • implant stability 14

    14 days after surgery

  • implant stability 1 month

    1 month after surgery

  • implant stability 2 months

    2 months after surgery

  • +7 more secondary outcomes

Study Arms (1)

narrow ridge

EXPERIMENTAL

edentulous site with crestal bone width comprised between 3,5 and 5 millimeters wedge shape implants insertion

Procedure: wedge shape implants insertion

Interventions

wedge shape implants insertionPROCEDURE

Narrow dental implants inserted in narrow ridges

narrow ridge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indications for prosthetic rehabilitation supported by implants in the upper or lower arch, based on accurate diagnosis and treatment planning;
  • the bone crest must be completely healed (at least six months after the tooth loss);
  • residual bone ridge width between 3.5 and 5 mm, at least 3 mm in apical direction;
  • presence of at least 10 mm bone height available for implant placement;
  • age of the patient\> 18 years;
  • The patient must not carry any removable prosthesis on the treated area;
  • the patient must be able to follow the protocol of study;
  • informed written consent

You may not qualify if:

  • acute myocardial infarction over the last 2 months;
  • uncontrolled coagulation disorders;
  • unmanaged diabetes (HBA1c\> 7.5);
  • radiotherapy to the head area in the last 24 months;
  • immunocompromised, HIV positive or chemotherapy patients over the past 5 years;
  • present or past treatment with intravenous bisphosphonates;
  • psychological or psychiatric problems;
  • abuse of alcohol or drugs;
  • uncontrolled periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piezosurgery Academy

Parma, PR, 43100, Italy

Location

Related Publications (3)

  • Chiapasco M, Zaniboni M. Clinical outcomes of GBR procedures to correct peri-implant dehiscences and fenestrations: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:113-23. doi: 10.1111/j.1600-0501.2009.01781.x.

    PMID: 19663958BACKGROUND

  • Danza M, Guidi R, Carinci F. Comparison between implants inserted into piezo split and unsplit alveolar crests. J Oral Maxillofac Surg. 2009 Nov;67(11):2460-5. doi: 10.1016/j.joms.2009.04.041.

    PMID: 19837318BACKGROUND

  • Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

    PMID: 12956475BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • claudio stacchi, Dr.

    Piezosurgery Academy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: multicenter single cohort prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of the Academy

Study Record Dates

First Submitted

July 21, 2017

First Posted

September 25, 2017

Study Start

May 15, 2017

Primary Completion

November 15, 2019

Study Completion

May 15, 2020

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)