Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial

Abstract

Background: Nowadays, short dental implants are being increasingly applied in extremely resorbed posterior regions. The recent studies have indicated that short implants present a similar success rate to conventional implants. It is assumed that short implants can avoid additional surgical morbidity and are less technically demanding. However, high-quality evidence (≥ Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of short implants and longer implants combined with osteotome sinus floor elevation (OSFE) technique is limited.

Methods/design: The proposed study is designed as a prospective single-center, three-arm parallel group, randomized controlled trial. We plan to enroll 150 patients in need of dental implant treatment in the posterior maxilla. The inclusion criteria include: age ≧ 18 years, partial edentulism in the posterior maxilla for at least 3 months from tooth loss, residual bone height ranging from 6 to 8 mm, sufficient bone width (≥ 6 mm) in the edentulous region. The patients will be divided into three groups according to a table of random numbers: group 1: short implants (6 mm) alone; group 2: short implants (8 mm) combined with osteotome sinus floor elevation (OSFE); group 3: standard implants (10 mm) combined with OSFE. The assignment will be concealed from the clinical operators until the beginning of implant surgery. The outcome examiners and patients will be kept blinded to the assignment. Implant survival rates, implant success rates, complications, resonance frequency analysis (RFA) measurements, marginal bone level, treatment time and patient-reported outcome (visual analogue scale for intraoperative discomfort and postoperative pain) will be recorded. Clinical re-evaluations will be performed at 12, 24, 36 and 60 months after crown placement.

Discussion: The results of the trial will support better decision-making for dental implant treatment in atrophic maxillary ridges. If favorable, the use of short implants may avoid adjunct procedures used for implant insertion, thus reducing operative time, complexity and postoperative discomfort.

Trial registration: Clinicaltrials.gov identifier: NCT02350075 (registered on 17 February 2015).