Standard Implants With Bone Regeneration vs Short Implants

NCT ID: NCT03524885

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Implant Complication Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Short implant placement

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Bone regeneration with longer implants

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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David Peñarrocha Oltra

Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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David Peñarrocha Oltra

Role: CONTACT

649952560

Facility Contacts

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David Peñarrocha Oltra

Role: primary

649952560

Other Identifiers

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H1506438508468

Identifier Type: -

Identifier Source: org_study_id

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