Implant-supported Rehabilitation With SPAL Technique or Soft Tissue Augmentation

Summary

The primary aim of the present study is to compare the Sub-periosteal Peri-implant Augmented Layer (SPAL) technique and soft tissue augmentation (STA), performed simultaneously to implant placement, in terms of (i) implant survival rate and (ii) health/disease condition of the peri-implant tissues at 6 and 12 months following implant loading. The secondary aim of the project will be to compare the SPAL technique and STA in terms of intra- and post-operative morbidity.

The study is designed as a single-blind, parallel-arm, randomized clinical trial. Patients will be recruited and treated at the Operative Unit of Dentistry, Azienda Unità Sanitaria Locale (A.U.S.L.) of Ferrara, Italy, and one University center (Research Centre for the Study of Periodontal and Peri-implant Diseases, University of Ferrara, Italy). Each patient will contribute the study with one sextant ("experimental sextant"). Each eligible patient will be randomly assigned to receive SPAL technique or STA according to a computer-generated randomization list. Surgical procedures will be performed by experienced periodontal and implant surgeons. Two calibrated, blinded examiners will take care of the assessment of clinical and radiographic parameters, Case Report Form (CRF) filling, as well as data extraction from CRFs for the preparation of the study database.

The proportion of patients free from peri-implantitis at 12 months following loading will be the primary outcome variable of the study. The proportion of patients with complete resolution of the bone dehiscence (BD), dimensional variations and 12-months characteristics of BD, and patient-reported outcome measures will be the secondary outcomes. The design will test two hypotheses, with a non-inferiority trial in terms of primary outcome and a superiority trial in terms of secondary outcomes.

Conditions

• Dehiscence
• Alveolar Ridge Enlargement
• Bone Loss, Alveolar

Interventions

PROCEDURE

Sub-Periosteal Peri-implant Augmented Layer technique

In patients assigned to the SPAL group, the management of the soft tissues will be performed according to the SPAL technique as originally described by Trombelli et al. (2018). Implant site preparation will be performed using a set of calibrated guided surgery steel burs under copious sterile saline irrigation. Implants will be placed, and a healing abutment will be positioned and screwed. The space underneath the periosteal layer will be then filled with a deproteinized bovine bone mineral (DBBM) graft. A sterile viscoelastic gel (SVG) based on polynucleotides and hyaluronic acid (REGENFAST®, Mastelli Srl, Sanremo, Italia) will be combined with the bone graft. The periosteal layer will be then secured to the oral flap by mean of 6/0 resorbable internal mattress sutures. SVG wil be placed underneath the mucosal layer and the latter will be coronally advanced and stabilized a using 6/0 resorbable internal mattress and sling sutures.

PROCEDURE

Soft tissue augmentation

In patients assigned to the STA group, flap management will be performed as described by Stefanini et al. (2016). Implant site preparation will be performed according to the same procedures described for the SPAL group. SVG will be placed underneath the buccal flap and the latter will be then released from tension by means of periosteal and muscular incisions, and will be coronally advanced and adapted to the healing abutment with a 6/0 resorbable sling suture. Interrupted sutures will be used to accomplish primary intention closure in the interproximal areas.

Sponsors & Collaborators

• Azienda USL Ferrara

  collaborator OTHER_GOV

• Università degli Studi di Ferrara

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2025-07-31

Completion

2025-12-31

Countries

• Italy

Study Locations