search
Back to results

Implant-supported Rehabilitation With SPAL Technique or Soft Tissue Augmentation (SPALvsSTA)

Primary Purpose

Dehiscence, Alveolar Ridge Enlargement, Bone Loss, Alveolar

Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Sub-Periosteal Peri-implant Augmented Layer technique
Soft tissue augmentation
Sponsored by
Università degli Studi di Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehiscence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Polo OdontoiatricoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Soft Tissue Augmentation (STA) simultaneous to implant placement

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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"
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.
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"
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)
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
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."

Full Information

First Posted
November 2, 2022
Last Updated
November 9, 2022
Sponsor
Università degli Studi di Ferrara
Collaborators
Azienda USL Ferrara
search

1. Study Identification

Unique Protocol Identification Number
NCT05610748
Brief Title
Implant-supported Rehabilitation With SPAL Technique or Soft Tissue Augmentation
Acronym
SPALvsSTA
Official Title
Implant-supported Rehabilitation of Atrophic Edentulous Sites With a Novel, Simplified Technique for Bone Augmentation or Soft Tissue Augmentation: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Ferrara
Collaborators
Azienda USL Ferrara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehiscence, Alveolar Ridge Enlargement, Bone Loss, Alveolar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The study is designed as a single-blind, parallel-arm, randomized trial.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sub-Periosteal Peri-implant Augmented Layer (SPAL) technique simultaneous to implant placement
Arm Type
Experimental
Arm Description
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.
Arm Title
Soft Tissue Augmentation (STA) simultaneous to implant placement
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sub-Periosteal Peri-implant Augmented Layer technique
Other Intervention Name(s)
SPAL
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Soft tissue augmentation
Other Intervention Name(s)
STA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients free from peri-implantitis
Description
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
Secondary Outcome Measure Information:
Title
Complete resolution of bone dehiscence (BD)
Description
Proportion of patients with complete resolution of BD as evaluated on CT/CBCT scan at 12 months following surgery
Time Frame
12-month visit
Title
Changes in height and width of bone dehiscence (BD)
Description
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
Title
Height and width of the residual bone dehiscence (BD)
Description
Height and width of bone dehiscence (BD) as evaluated on CT/CBCT scan at 12-month visit
Time Frame
12-month visit
Title
Pain
Description
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
Title
Dose of rescue anti-inflammatory drug
Description
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
Title
Discomfort
Description
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
Title
Limitations in daily functions
Description
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
Title
Incidence of postoperative signs and symptoms
Description
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
Title
Willingness to undergo the same type of surgery
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo Trombelli, Principal Investigator
Phone
+39 0532 688507
Email
leonardo.trombelli@unife.it
Facility Information:
Facility Name
Polo Odontoiatrico
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Trombelli, prof.
Phone
+39 0532 688507
Email
leonardo.trombelli@unife.it

12. IPD Sharing Statement

Learn more about this trial

Implant-supported Rehabilitation With SPAL Technique or Soft Tissue Augmentation

We'll reach out to this number within 24 hrs