Standard Implants With Bone Regeneration vs Short Implants

• ClinicalTrials.gov Identifier: NCT03524885
• Recruitment Status: Recruiting
• First Posted: May 15, 2018
• Last Update Posted: November 14, 2018
• Sponsor: University of Valencia
• Information provided by (Responsible Party): David Peñarrocha Oltra, University of Valencia

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.

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

Study Design

• 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

Arms and Interventions

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).

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: David Peñarrocha Oltra; 649952560; david.penarrocha@uv.es

Locations

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

More 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
• 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

Additional relevant MeSH terms:

Bone Resorption; Bone Diseases; Musculoskeletal Diseases