NCT03357406

Brief Summary

multi center study with randomized controlled trial design, split mouth

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

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

February 15, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.4 years

First QC Date

November 23, 2017

Last Update Submit

November 28, 2017

Conditions

Bone Atrophy, Alveolar

Keywords

implantpiezoelectricdrillsimmediate loading

Outcome Measures

Primary Outcomes (1)

  • implant survival rate

    how many implant are present in mouth

    two years after surgery

Secondary Outcomes (3)

  • implant success rate

    two years after surgery

  • biomechanical complications

    two years after surgery

  • marginal bone loss

    two years after surgery

Study Arms (2)

edentulism side 1

EXPERIMENTAL

ultrasound implant site preparation

Procedure: ultrasound implant site preparation

edentulism side 2

ACTIVE COMPARATOR

conventional implant site preparation

Procedure: conventional implant site preparation

Interventions

ultrasound implant site preparationPROCEDURE

piezoelectric bone surgery will be used to create implant bone ostectomy

edentulism side 1
conventional implant site preparationPROCEDURE

twist drills will be used to create implant bone ostectomy

edentulism side 2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indications for two implant-supported single crowns with immediate loading in the upper or lower arch (in the incisor, canine or premolar area), based on accurate diagnosis and treatment planning; 2) implants can be in the same or in different quadrants; 3) implant sites must be performed in similar bone quality (i.e. both maxillary or mandibular); 4) the bone crest must be healed (at least three months elapsed after tooth loss); 5) presence of a residual bone crest with an adequate volume to allow the insertion of a 3.8x11.5 mm implant without any kind of regenerative procedure; 6) age of the patient \>18 years; 7) patient willing and fully capable to comply with the study protocol; 8) written informed consent given;

You may not qualify if:

  • acute myocardial infarction within the past 2 months;
  • uncontrolled coagulation disorders;
  • uncontrolled diabetes (HBA1c \> 7.5%);
  • radiotherapy to the head/neck district within the past 24 months;
  • immunocompromised patient (HIV infection or chemotherapy within the past 5 years);
  • present or past treatment with intravenous bisphosphonates;
  • psychological or psychiatric problems;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (3)

  • Vercellotti T, Stacchi C, Russo C, Rebaudi A, Vincenzi G, Pratella U, Baldi D, Mozzati M, Monagheddu C, Sentineri R, Cuneo T, Di Alberti L, Carossa S, Schierano G. Ultrasonic implant site preparation using piezosurgery: a multicenter case series study analyzing 3,579 implants with a 1- to 3-year follow-up. Int J Periodontics Restorative Dent. 2014 Jan-Feb;34(1):11-8. doi: 10.11607/prd.1860.

    PMID: 24396835BACKGROUND

  • Esposito M, Grusovin MG, Achille H, Coulthard P, Worthington HV. Interventions for replacing missing teeth: different times for loading dental implants. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD003878. doi: 10.1002/14651858.CD003878.pub4.

    PMID: 19160225BACKGROUND

  • Khayat PG, Arnal HM, Tourbah BI, Sennerby L. Clinical outcome of dental implants placed with high insertion torques (up to 176 Ncm). Clin Implant Dent Relat Res. 2013 Apr;15(2):227-33. doi: 10.1111/j.1708-8208.2011.00351.x. Epub 2011 May 20.

    PMID: 21599832BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Claudio Stacchi, Dr

    Piezosurgery Academy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
treatment method is masked till the surgical procedure, during which, both surgeon and patient are informed
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Split mouth design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of International Piezosurgery Academy

Study Record Dates

First Submitted

November 23, 2017

First Posted

November 29, 2017

Study Start

February 15, 2016

Primary Completion

July 15, 2017

Study Completion

November 15, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)