Standard Implants With Bone Regeneration vs Short Implants

Bone Resorption Clinical Trial

Official title:

Standard Implants With Bone Regeneration vs Short Implants (Implantes Convencionales Con regeneración ósea vs. Implantes Cortos)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03524885
• Other study ID #: H1506438508468
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: University of Valencia
• Contact: David Peñarrocha Oltra
• Phone: 649952560
• Email: david.penarrocha[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Resorption
• Implant Complication

Intervention

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.
• 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).

Locations

Country	Name	City	State
Spain	Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-implant bone level changes	Interproximal bone level measured on a periapical film taken with a Rinn Holder	12 months after implant loading
Secondary	Patient satisfaction	by means a Visual Analogue Scale ranging between 0 (lowest) and 10 (highest)	12 months after implant loading
Secondary	Implant survival rate	% of implants in function	12 months after implant loading