Standard Implants With Bone Regeneration vs Short Implants

Not Applicable

• Conditions: Bone Resorption; Implant Complication

• Registration Number: NCT03524885
• Lead Sponsor: University of Valencia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-03-03
• Study First Submitted QC: 2018-05-13
• Study First Posted: 2018-05-15
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-11
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peri-implant bone level changes	12 months after implant loading	Interproximal bone level measured on a periapical film taken with a Rinn Holder

Secondary Outcome Measures

Name	Time	Method
Implant survival rate	12 months after implant loading	% of implants in function
Patient satisfaction	12 months after implant loading	by means a Visual Analogue Scale ranging between 0 (lowest) and 10 (highest)

Trial Locations

Locations (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis; 🇪🇸 Valencia, Spain