Back to resultsStandard Implants With Bone Regeneration vs Short Implants
Primary Purpose
Implant Complication, Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Short implant placement
Bone regeneration with longer implants
Sponsored by
About this trial
This is an interventional treatment trial for Implant Complication
Eligibility 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
Sites / Locations
- Clínica Odontológica de la Universitat de Valencia, Fundación Lluis AlcanyisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Short implants
Bone regeneration with longer implants
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Peri-implant bone level changes
Interproximal bone level measured on a periapical film taken with a Rinn Holder
Secondary Outcome Measures
Patient satisfaction
by means a Visual Analogue Scale ranging between 0 (lowest) and 10 (highest)
Implant survival rate
% of implants in function
Full Information
NCT ID
NCT03524885
First Posted
March 3, 2018
Last Updated
November 11, 2018
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT03524885
Brief Title
Standard Implants With Bone Regeneration vs Short Implants
Official Title
Standard Implants With Bone Regeneration vs Short Implants (Implantes Convencionales Con regeneración ósea vs. Implantes Cortos)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implant Complication, Bone Resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short implants
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bone regeneration with longer implants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Short implant placement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bone regeneration with longer implants
Intervention Description
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 Measure Information:
Title
Peri-implant bone level changes
Description
Interproximal bone level measured on a periapical film taken with a Rinn Holder
Time Frame
12 months after implant loading
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
by means a Visual Analogue Scale ranging between 0 (lowest) and 10 (highest)
Time Frame
12 months after implant loading
Title
Implant survival rate
Description
% of implants in function
Time Frame
12 months after implant loading
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Peñarrocha Oltra
Phone
649952560
Email
david.penarrocha@uv.es
Facility Information:
Facility Name
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Peñarrocha Oltra
Phone
649952560
Email
david.penarrocha@uv.es
12. IPD Sharing Statement
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Standard Implants With Bone Regeneration vs Short Implants
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