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Completed

NCT Number: NCT03524885

Standard Implants With Bone Regeneration vs Short Implants

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.

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Key information

Conditions

Implant Complication Bone Diseases Bone Resorption Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 15, 2018
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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