Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Standard Implants With Bone Regeneration vs Short Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03524885
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
David Peñarrocha Oltra, University of Valencia

Brief Summary:

A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to compare, considering different parameters, the rehabilitation with dental implants of atrophic posterior mandibles or maxillae using short implants or longer implants with vertical bone regeneration with GBR.

The hypothesis of the study is that both treatment options will be successful to rehabilitate atrophic posterior mandibles or maxillae. Moreover, more surgical complications will be encountered in the bone regeneration group.


Condition or disease Intervention/treatment Phase
Implant Complication Bone Resorption Procedure: Short implant placement Procedure: Bone regeneration with longer implants Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standard Implants With Bone Regeneration vs Short Implants (Implantes Convencionales Con regeneración ósea vs. Implantes Cortos)
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: Short implants
2 or 3 implant 4-5 mm length and 4 mm diameter (Syra Short, Sweden & Martina, Padua, Italy) will be positioned. The healing cap will be immediately connected and a vycril suture will be done after soft tissue reflection.
Procedure: Short implant placement

Ten patients will be randomly selected for the short implants option, 2 or 3 implant 4-5 mm length and 4 mm diameter (Syra Short, Sweden & Martina, Padua, Italy) will be positioned. The healing cap will be immediately connected and a vycril suture will be done after soft tissue reflection.

After three months an acrylic screw-retained bridge will be delivered. After further three months, a definitive restauration with a metal ceramic bridge will be seated.


Experimental: Bone regeneration with longer implants

A horizontal and vertical regeneration following GBR technique will be performed using not-resorbable PTFE titanium reinforced membrane (Cytoplast Osteogenics, US) fixed by titanium pins or miniscrews to ensure the perfect stability (Pro-fix, Cytoplast Osteogenics, US).

The graft will be composed half autogenous bone harvested with a scraper (Meta, Firenze, Italy) by the same surgical site or by a second tunnel site in the mandibular ramus and half deproteinized bovine bone (Bio Oss Geislicht Pharma, Switzerland). The mucosal flaps will be sutured in a double layer with horizontal mattress and single gore-tex sutures (Cytoplast PTFE sutures 3.0, Cytoplast Osteogenics, US).

2 or 3 implant from 10 to 13 mm length putting the implant platform 2 or 3 mm apical to CEJ of the adjacent tooth will be inserted.

Procedure: Bone regeneration with longer implants

Ten patients will be randomly assigned to the regenerative group, 2 or 3 implant from 10 to 13 mm length intentionally exposed putting the implant platform 2 or 3 mm apical to CEJ of the adjacent tooth will be inserted.

A horizontal and vertical regeneration following GBR technique will be performed using not-resorbable PTFE titanium reinforced membrane (Cytoplast Osteogenics, US) fixed by titanium pins or miniscrews to ensure the perfect stability (Pro-fix, Cytoplast Osteogenics, US).





Primary Outcome Measures :
  1. Peri-implant bone level changes [ Time Frame: 12 months after implant loading ]
    Interproximal bone level measured on a periapical film taken with a Rinn Holder


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 12 months after implant loading ]
    by means a Visual Analogue Scale ranging between 0 (lowest) and 10 (highest)

  2. Implant survival rate [ Time Frame: 12 months after implant loading ]
    % of implants in function



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All the patients with a distal edentulism Kennedy -Applegate Class II in the posterior mandible or maxilla, with residual bone height from the top of the crest to the opposite landmark (the alveolar nerve for the lower and the sinus cavity for the upper) between 5 and 7 millimeters. The bone peak on the last tooth before the edentulous space must be positioned from 2 to 4 mm from the CEJ. (X-ray evaluation by periapical film on a Rinn Holder).
  • All patients with at least 3 mm of keratinized tissue on the edentulous crest. In case of absence of this prerequisite, three months before the keratinized tissue is augmented by a ephytelium-connective tissue graft harvested from the palate.
  • Patients with edentulous distal sites

Exclusion Criteria:

  • Heavy smokers (more than 10 cigarettes /day)
  • Patients with active periodontal disease: full mouth plaque index (FMPI > 20%) and Full mouth bleeding index (FMBI > 20%).
  • Patients with less of 5 mm of bone width.
  • Patients with systemic conditions or under prescription of medications that contraindicate oral surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524885


Contacts
Layout table for location contacts
Contact: David Peñarrocha Oltra 649952560 david.penarrocha@uv.es

Locations
Layout table for location information
Spain
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis Recruiting
Valencia, Spain, 46010
Contact: David Peñarrocha Oltra    649952560    david.penarrocha@uv.es   
Sponsors and Collaborators
University of Valencia

Layout table for additonal information
Responsible Party: David Peñarrocha Oltra, Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor), University of Valencia
ClinicalTrials.gov Identifier: NCT03524885     History of Changes
Other Study ID Numbers: H1506438508468
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bone Resorption
Bone Diseases
Musculoskeletal Diseases