Standard Implants With Bone Regeneration vs Short Implants

NCT03524885 | Unknown

• 1 other identifier: H1506438508468
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant Complication; Bone Resorption

Outcome Measures

Primary Outcomes (1)

• Peri-implant bone level changes

  Interproximal bone level measured on a periapical film taken with a Rinn Holder

  12 months after implant loading

Secondary Outcomes (2)

• Patient satisfaction

  12 months after implant loading

• Implant survival rate

  12 months after implant loading

Study Arms (2)

Short implants

ACTIVE COMPARATOR

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

Bone regeneration with longer implants

EXPERIMENTAL

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

Interventions

Short implant placement PROCEDURE

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.

Short implants

Bone regeneration with longer implants PROCEDURE

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).

Bone regeneration with longer implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Bone Resorption

Interventions

Bone Regeneration

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Bone Remodeling; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Regeneration; Biological Phenomena

Central Study Contacts

David Peñarrocha Oltra

CONTACT

649952560; david.penarrocha@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: May 15, 2018
• Study Start: January 8, 2018
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

ES (1)