NCT05610748: SPALvsSTA

Implant-supported Rehabilitation With SPAL Technique or Soft Tissue Augmentation

Active, enrolled Phase 4 Last updated 27 March 2025

What this trial tests

Phase 4 trial testing Sub-Periosteal Peri-implant Augmented Layer technique in Dehiscence in 66 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 July 2022

Primary endpoint
31 July 2025

31 December 2025

Quick facts

Lead sponsor	Università degli Studi di Ferrara
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	66
Start date	1 July 2022
Primary completion	31 July 2025
Estimated completion	31 December 2025
Sites	1 location across Italy

Drugs / interventions tested

• Sub-Periosteal Peri-implant Augmented Layer technique
• Soft tissue augmentation

Conditions studied

• Dehiscence — all drugs for Dehiscence →
• Alveolar Ridge Enlargement — all drugs for Alveolar Ridge Enlargement →
• Bone Loss, Alveolar — all drugs for Bone Loss, Alveolar →

Sponsor

Università degli Studi di Ferrara — full company profile →

Who can join

21 and older, any sex, with Dehiscence or Alveolar Ridge Enlargement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.