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Conventional and Ultrasonic Implant Site Preparation

NCT ID: NCT03357406

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-15

Study Completion Date

2017-11-15

Brief Summary

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multi center study with randomized controlled trial design, split mouth

Detailed Description

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The present study has been designed as a multicenter prospective randomized controlled trial design. Fifteen clinical centers will treat patients by inserting and immediately loading implants with two different surgical protocols. Each patient will receive two identical implants: after randomization, the test site will be prepared by ultrasonic microvibrations and the control site using twist drills. Both implants will be loaded with a provisional crown within 48 hours after surgery. For each inserted implant, collection of experimental parameters will be required up to 2 years after surgery.

Conditions

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Bone Atrophy, Alveolar

Keywords

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implant piezoelectric drills immediate loading

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Split mouth design
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
treatment method is masked till the surgical procedure, during which, both surgeon and patient are informed

Study Groups

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edentulism side 1

ultrasound implant site preparation

Group Type EXPERIMENTAL

ultrasound implant site preparation

Intervention Type PROCEDURE

piezoelectric bone surgery will be used to create implant bone ostectomy

edentulism side 2

conventional implant site preparation

Group Type ACTIVE_COMPARATOR

conventional implant site preparation

Intervention Type PROCEDURE

twist drills will be used to create implant bone ostectomy

Interventions

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ultrasound implant site preparation

piezoelectric bone surgery will be used to create implant bone ostectomy

Intervention Type PROCEDURE

conventional implant site preparation

twist drills will be used to create implant bone ostectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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;

Exclusion Criteria

1. acute myocardial infarction within the past 2 months;
2. uncontrolled coagulation disorders;
3. uncontrolled diabetes (HBA1c \> 7.5%);
4. radiotherapy to the head/neck district within the past 24 months;
5. immunocompromised patient (HIV infection or chemotherapy within the past 5 years);
6. present or past treatment with intravenous bisphosphonates;
7. psychological or psychiatric problems;
8. alcohol or drugs abuse Local exclusion criterion is the presence of uncontrolled or untreated periodontal disease (full mouth plaque score and full mouth bleeding score \> 25%)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Piezosurgery Academy

OTHER

Sponsor Role lead

Responsible Party

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Mr. Claudio Stacchi, DDS, MSc

President of International Piezosurgery Academy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio Stacchi, Dr

Role: STUDY_DIRECTOR

Piezosurgery Academy

Locations

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Piezosurgery Academy

Parma, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 24396835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19160225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21599832 (View on PubMed)

Other Identifiers

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piezo-drills

Identifier Type: -

Identifier Source: org_study_id