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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03524885 |
Recruitment Status : Unknown
Verified November 2018 by David Peñarrocha Oltra, University of Valencia.
Recruitment status was: Recruiting
First Posted : May 15, 2018
Last Update Posted : November 14, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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). |
- 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
- Patient satisfaction [ Time Frame: 12 months after implant loading ]by means a Visual Analogue Scale ranging between 0 (lowest) and 10 (highest)
- Implant survival rate [ Time Frame: 12 months after implant loading ]% of implants in function

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: David Peñarrocha Oltra | 649952560 | david.penarrocha@uv.es |
Spain | |
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis | Recruiting |
Valencia, Spain, 46010 | |
Contact: David Peñarrocha Oltra 649952560 david.penarrocha@uv.es |
Responsible Party: | David Peñarrocha Oltra, Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor), University of Valencia |
ClinicalTrials.gov Identifier: | NCT03524885 |
Other Study ID Numbers: |
H1506438508468 |
First Posted: | May 15, 2018 Key Record Dates |
Last Update Posted: | November 14, 2018 |
Last Verified: | November 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bone Resorption Bone Diseases Musculoskeletal Diseases |