Clinical trial NCT03357406: Conventional and Ultrasonic Implant Site Preparation
Official title: Immediate Loading After Conventional and Ultrasonic Implant Site Preparation: a Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Atrophy, Alveolar
Keywords: implant
piezoelectric
drills
immediate loading
Lead sponsor: International Piezosurgery Academy
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split mouth design
Primary purpose: TREATMENT

Brief summary: multi center study with randomized controlled trial design, split mouth

Detailed 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.

Eligibility criteria: 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%)

Primary outcomes:
measure: implant survival rate
timeFrame: two years after surgery
Secondary outcomes:
measure: implant success rate
timeFrame: two years after surgery
measure: biomechanical complications
timeFrame: two years after surgery
measure: marginal bone loss
timeFrame: two years after surgery
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Piezosurgery Academy
Study officials:
affiliation: Piezosurgery Academy
name: Claudio Stacchi, Dr
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.