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DehiscencePhase 4SPALvsSTANCT05610748

Implant-supported Rehabilitation With SPAL Technique or Soft Tissue Augmentation

A Phase 4 study testing Sub-Periosteal Peri-implant Augmented Layer technique and Soft tissue augmentation in people with Dehiscence and Alveolar Ridge Enlargement, run by Università degli Studi di Ferrara at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Sub-Periosteal Peri-implant Augmented Layer technique and Soft tissue augmentation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteItaly
Study dates
1 Jul 2022to 31 Dec 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Patient-specific inclusion criteria

  • 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.

Sextant-specific inclusion criteria

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.

Patient will not be eligible for the study if presenting at least one of the following exclusion criteria:

Patient-specific exclusion criteria

  • 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;
  • development of conditions conflicting with the inclusion criteria listed above;
  • failure to comply with study instructions/requirements.

Site specific exclusion criteria

  • 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;
  • previous bone augmentation/preservation procedures at the designated implant areas;
  • need for vertical bone augmentation.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Polo Odontoiatrico

    Ferrara, 44121

Other trials in Italy

About this study

Official title: Implant-supported Rehabilitation of Atrophic Edentulous Sites With a Novel, Simplified Technique for Bone Augmentation or Soft Tissue Augmentation: a Randomized Trial

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.

Being tested
Sub-Periosteal Peri-implant Augmented Layer technique, Soft tissue augmentation
Medical subject headings
Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sub-Periosteal Peri-implant Augmented Layer techniqueProcedure or surgery

    Also called SPAL

    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.

  • Soft tissue augmentationProcedure or surgery

    Also called STA

    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.

Study groups in NCT05610748
Study groupRoleWhat they receive
Sub-Periosteal Peri-implant Augmented Layer (SPAL) technique simultaneous to implant placementExperimentalIn 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.
Receives: Procedure: Sub-Periosteal Peri-implant Augmented Layer technique
Soft Tissue Augmentation (STA) simultaneous to implant placementActive comparatorIn 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.
Receives: Procedure: Soft tissue augmentation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12-month visit

Secondary outcomes (9)

  1. 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

    Measured: 12-month visit

  2. 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

    Measured: Pre-surgery and 12-month visits

  3. 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

    Measured: 12-month visit

  4. 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"

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

  5. 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.

    Measured: First 14 days following surgery

  6. 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"

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

  7. 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)

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

  8. 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

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

  9. 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."

    Measured: Day +14 following surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2022
  2. Study start1 Jul 2022
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is designed as a single-blind, parallel-arm, randomized trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610748
Sponsor's protocol ID
FIN-RER_BU_2020_45
Acronym
SPALvsSTA
Status last verified
Mar 2025
First submitted
2 Nov 2022
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sub-Periosteal Peri-implant Augmented Layer technique and Soft tissue augmentation in people with Dehiscence and Alveolar Ridge Enlargement, run by Università degli Studi di Ferrara at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients free from peri-implantitis (time frame: 12-month visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05610748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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