A Phase 4 interventional study of Sub-Periosteal Peri-implant Augmented Layer technique and Soft tissue augmentation in Dehiscence, Alveolar Ridge Enlargement and Bone Loss, Alveolar, sponsored by Università degli Studi di Ferrara. Active, not recruiting at 1 site in Italy. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Università degli Studi di Ferrara · Phase 4, Interventional, and Treatment
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.
297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.
This study's enrollment of 66 is above the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Università degli Studi di Ferrara is the lead sponsor of 64 studies on the registry; 10 are open to participants now.
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Patient-specific inclusion criteria
Sextant-specific inclusion criteria
To be considered as experimental, a sextant will have to fulfill all the following criteria:
Patient will not be eligible for the study if presenting at least one of the following exclusion criteria:
Patient-specific exclusion criteria
Moreover, participants immediately exited the study upon:
Site specific exclusion criteria
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: Sub-Periosteal Peri-implant Augmented Layer technique
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.
Procedure: Soft tissue augmentation
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.
Also known as: SPAL
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.
Also known as: STA
Proportion of patients free from peri-implantitis
Proportion of patients free from peri-implantitis (diagnosed according to the criteria described by Berglundh et al. 2018) at 12 months following loading
Time frame: 12-month visit
Complete resolution of bone dehiscence (BD)
Proportion of patients with complete resolution of BD as evaluated on CT/CBCT scan at 12 months following surgery
Time frame: 12-month visit
Changes in height and width of bone dehiscence (BD)
Variations in height and width of bone dehiscence (BD) (as evaluated on CT/CBCT scan) occurred between pre-surgery visit 12-month visits
Time frame: Pre-surgery and 12-month visits
Height and width of the residual bone dehiscence (BD)
Height and width of bone dehiscence (BD) as evaluated on CT/CBCT scan at 12-month visit
Time frame: 12-month visit
Pain
Level of pain recorded in the evening at day 0, +1, +2, +3, +4, +7 and +14 on a 100-mm visual analogue scale (VAS) ranging from "0-no pain" to "100-worst pain imaginable"
Time frame: Day 0, +1, +2, +3, +4, +7 and +14 following surgery
Dose of rescue anti-inflammatory drug
Dosage of rescue anti-inflammatory drug (i.e. number of ibuprofen 600 mg tablets) and other types of medications taken from the day of surgery to the 14th postoperative day, as recorded daily on a medication diary.
Time frame: First 14 days following surgery
Discomfort
Level of discomfort, as recorded at day 0 (evening), +1, +2, +3, +4, +7 and +14 on a 5-point rating scale ranging from "no discomfort" to "very high discomfort"
Time frame: Day 0, +1, +2, +3, +4, +7 and +14 following surgery
Limitations in daily functions
Limitations in daily functions (i.e., swallowing, continuing daily activities, eating, speaking, opening the mouth, sleeping), as recorded at day 0 (evening), +1, +2, +3, +4, +7 and +14 on a 5-point rating scale ranging from "no limitations" to "unable to eat a lot of types of food" (for the "eating" item), and from "not at all difficult" to "extremely difficult" (for the other items)
Time frame: Day 0, +1, +2, +3, +4, +7 and +14 following surgery
Incidence of postoperative signs and symptoms
Incidence of postoperative signs and symptoms (i.e., swelling, nausea, bruising, bad taste/smell) at day 0 (evening), +1, +2, +3, +4, +7 and +14
Time frame: Day 0, +1, +2, +3, +4, +7 and +14 following surgery
Willingness to undergo the same type of surgery
Willingness to undergo the same type of surgery, recorded at day +14 on a 4-point rating scale ranging from "no problem to repeat surgery if needed" to "I will never undergo this type of surgery again."
Time frame: Day +14 following surgery
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Università degli Studi di Ferrara