Conventional and Ultrasonic Implant Site Preparation

Bone Atrophy, Alveolar Clinical Trial

— PI-DRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357406
• Other study ID #: piezo-drills
• Status: Completed
• Phase: N/A
• First received: November 23, 2017
• Last updated: November 28, 2017
• Start date: February 15, 2016
• Est. completion date: November 15, 2017

Study information

• Verified date: November 2017
• Source: International Piezosurgery Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

multi center study with randomized controlled trial design, split mouth

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 15, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Atrophy
• Bone Atrophy, Alveolar

Intervention

Procedure:
• ultrasound implant site preparation
piezoelectric bone surgery will be used to create implant bone ostectomy
• conventional implant site preparation
twist drills will be used to create implant bone ostectomy

Locations

Country	Name	City	State
Italy	Piezosurgery Academy	Parma

Sponsors (1)

Lead Sponsor	Collaborator
International Piezosurgery Academy

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Review. Update in: Cochrane Database Syst Rev. 2013;3:CD003878. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implant survival rate	how many implant are present in mouth	two years after surgery
Secondary	implant success rate	implant stable and fulfilling success criteria	two years after surgery
Secondary	biomechanical complications	every complication linked to the crown, implant abutment structure	two years after surgery
Secondary	marginal bone loss	radiographically assessed bone level	two years after surgery