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OpenTrials
Completed

NCT Number: NCT03357406

Conventional and Ultrasonic Implant Site Preparation

multi center study with randomized controlled trial design, split mouth

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piezosurgery Academy

Parma, 43100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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;
  • 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%)

Treatment and study plan

ultrasound implant site preparation

Procedure

piezoelectric bone surgery will be used to create implant bone ostectomy

conventional implant site preparation

Procedure

twist drills will be used to create implant bone ostectomy

Primary outcomes

  1. implant survival rate

    Time frame: two years after surgery

    how many implant are present in mouth

Secondary outcomes

  1. implant success rate

    Time frame: two years after surgery

    implant stable and fulfilling success criteria

  2. biomechanical complications

    Time frame: two years after surgery

    every complication linked to the crown, implant abutment structure

  3. marginal bone loss

    Time frame: two years after surgery

    radiographically assessed bone level

Sponsors and collaborators

Lead sponsor

International Piezosurgery Academy

Other

Registry information

Official study title

Immediate Loading After Conventional and Ultrasonic Implant Site Preparation: a Multicenter Randomized Controlled Clinical Trial

Acronym: PI-DRI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2017
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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