Implant-supported Rehabilitation With SPAL Technique or Soft Tissue Augmentation

NCT05610748 | Active Not Recruiting Phase 4

• 1 other identifier: FIN-RER_BU_2020_45
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  12-month visit

Secondary Outcomes (9)

• Complete resolution of bone dehiscence (BD)

  12-month visit

• Changes in height and width of bone dehiscence (BD)

  Pre-surgery and 12-month visits

• Height and width of the residual bone dehiscence (BD)

  12-month visit

• Pain

  Day 0, +1, +2, +3, +4, +7 and +14 following surgery

• Dose of rescue anti-inflammatory drug

  First 14 days following surgery

Study Arms (2)

Sub-Periosteal Peri-implant Augmented Layer (SPAL) technique simultaneous to implant placement

EXPERIMENTAL

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

Soft Tissue Augmentation (STA) simultaneous to implant placement

ACTIVE COMPARATOR

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

Interventions

Sub-Periosteal Peri-implant Augmented Layer technique PROCEDURE

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

Sub-Periosteal Peri-implant Augmented Layer (SPAL) technique simultaneous to implant placement

Soft tissue augmentation PROCEDURE

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

Soft Tissue Augmentation (STA) simultaneous to implant placement

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age≥21years;
• good physical status (ASA1 and ASA2 according to Physical Status Classification System) (American Society of Anesthesiologists, 2010);
• systemic and local conditions compatible with implant placement and experimental procedures;
• indication to a fixed, implant-supported prosthetic rehabilitation with hard or soft tissue reconstructive procedures as part of the comprehensive oral rehabilitation plan;
• patient willing and fully capable to comply with the study protocol.
• To be considered as experimental, a sextant will have to fulfill all the following criteria:
• including at least one healed (i.e., ≥ 6 months elapsed from tooth loss) edentulous site;
• horizontal dimension of the edentulous ridge compatible with the primary stability of an implant of at least 3.5 mm in diameter;
• expected peri-implant buccal BD characterized by a height (measured as the apico-coronal height of the exposed implant surface) ≤ 5 mm or a thin (\< 1 mm) peri-implant buccal bone plate as diagnosed on tridimensional planning for guided implant placement.

You may not qualify if:

• current heavy smoking (≥20 cigarettes/day for ≥6 months prior to and at the time of the surgical procedure);
• untreated periodontal disease prior to implant placement;
• history of radiation therapy in the head and neck area;
• history of chemotherapy;
• systemic disease or conditions with a documented effect on bone metabolism and/or osseous healing;
• past (within 6 months prior to enrolment in the study) or current treatment with any medication with a documented effect on bone metabolism and/or osseous healing;
• documented allergy to dental materials involved in the experimental protocol;
• pregnancy or lactation;
• history of drug or alcohol abuse.
• Moreover, participants immediately exited the study upon:
• request to withdraw from further participation;
• development of acute dental, peri-implant or oral conditions requiring treatment;
• failure to comply with study instructions/requirements.
• presence of either a buccal BD \> 5 mm in depth or a thick (≥ 1 mm) peri-implant buccal bone plate as clinically assessed with a periodontal probe immediately after implant placement;
• presence of endodontic lesions at teeth adjacent to the implant site;

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• Azienda USL Ferrara: collaborator

Study Sites (1)

Polo Odontoiatrico

Ferrara, 44121, Italy

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assignment of eligible patients to treatment will be recorded using sealed envelopes and will be disclosed to each clinical operator at the end of the screening appointment. The examiners will be kept blinded as to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor and Chair of Periodontology

Model Details: The study is designed as a single-blind, parallel-arm, randomized trial.

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: July 1, 2022
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

IT (1)