Bone LossNCT05475730
Tunnel Access for Lateral Alveolar Ridge Augmentation
A study testing bone and soft tissue augmentation in people with Bone Loss and Implant Site Injury, run by D'Albis Dental at 1 site in Italy.
Trial summary
Minimally invasive procedures with the tunnel technique have been suggested to decrease patient post-operative discomfort and morbidity in oral bone regeneration. In the ridge augmentation tunnel technique, crestal incision and the release of the connective tissue are avoided in order to enhance the blood supply of… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Implant Site Injury
- What is being tested?
- bone and soft tissue augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Patients had to be healthy according to System of the American Society of Anesthesiology (ASA) and aged 18 years or older
- No general medical condition representing a contraindication to implant therapy
- minimum 2 missing teeth in the maxilla or mandible from the canine to the second molar
- No periodontal disease (periodontal probing depth <4 mm) or treated periodontitis
- Good oral hygiene (full mouth plaque index<25%)
- Adequate control of inflammation (full mouth bleeding on probing<25%)
Who cannot join
- smoking of more than 15 cigarettes a day
- untreated periodontal disease
- pregnancy or breastfeeding at date of inclusion
- acute infections
- keratinized mucosal tissue less than 2 mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tunnel Access for Ridge Augmentation Using Xenogenous Bone, Hyaluronic Acid and Acellular Dermal Matrix
Minimally invasive procedures with the tunnel technique have been suggested to decrease patient post-operative discomfort and morbidity in oral bone regeneration. In the ridge augmentation tunnel technique, crestal incision and the release of the connective tissue are avoided in order to enhance the blood supply of the flap. This approach preserves the blood circulation and does not damage the periosteum The purpose of this study is to evaluate the clinical outcome of a minimally invasive technique for maxillofacial horizontal bone augmentation .
performed by using a collagen dermal matrix, deproteinized bovine bone and hyaluronic acid.
Collagen matrix is inserted into a sub-periosteal tunnel using microsurgical instruments. Deproteinized bovine bone in a hyaluronic acid carrier are placed and inserted repeatedly into the pocket and absorbable suture is used to close the vertical incision.
Read the detailed description
Tunnel bone regeneration achieves treatment objectives using the least invasive surgical approach.The goal is to increase patient satisfaction, decrease post-operative discomfort and morbidity.Preservation of the integrity of the periosteum is a determining factor in reducing postoperative pain and improving wound vascularization.
The present study value the clinical results of a subperiosteal minimally invasive ridge horizontal augmentation technique.
The technique includes the use of a laparoscopic approach to deliver hyaluronic acid,xenograft and a dermal matrix into a subperiosteal pouch.
- Conditions
- Bone Loss, Implant Site Injury
- Being tested
- bone and soft tissue augmentation
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone and soft tissue augmentationProcedure or surgery
Also called Bone regeneration
A vertical full-thickness incision in the mesial aspect of the defect ridge.Microsurgery instruments is subsequently use to carefully elevate the full thickness of the mucosa.
Extreme caution must be exercised during these maneuvers to avoid tissue perforation and to maintain the integrity of the periosteum.An dermal matrix is place into the tunnel.A pouch is create between the bone and the membrane and the mixed bone chips and hyaluronic acid are inserted into the tunnel until the desirable ridge dimensions are obtained. Primary closure of the vertical incisions was achieved with single interrupted sutures.
| Study group | Role | What they receive |
|---|---|---|
| Bone regeneration | Experimental | Minimally invasive horizontal bone augmentation using hyaluronic acid, deproteinized bovine bone and dermal matrix. Receives: Procedure: bone and soft tissue augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Augmented tissue volume
The edentulous ridge will be scanned with an intraoral scan 3 times. First time: Initial situation. Second time: 5 months after regeneration. Third time: After implant placement. Will be evaluate the 3 scan in a cad-cam software to evaluate the ridge three-dimensional changes.
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Albis Dental
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe D'Albis, D'Albis Dental
- Investigators
- Giuseppe D'Albis, Study director, D'Albis Dental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475730
- Sponsor's protocol ID
- 2022
- Status last verified
- Apr 2023
- First submitted
- 15 Jan 2022
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kfir E, Kfir V, Eliav E, Kaluski E. Minimally invasive guided bone regeneration. J Oral Implantol. 2007;33(4):205-10. doi: 10.1563/1548-1336(2007)33[205:MIGBR]2.0.CO;2.
PubMed 17912961Karmon B, Tavelli L, Rasperini G. Tunnel Technique with a Subperiosteal Bag for Horizontal Ridge Augmentation. Int J Periodontics Restorative Dent. 2020 Mar/Apr;40(2):223-230. doi: 10.11607/prd.4508.
PubMed 32032406Rasperini G, Tavelli L, Barootchi S, Karmon B. Tunnel Technique with a Subperiosteal Bag for Ridge Augmentation: A Case Series. Int J Periodontics Restorative Dent. 2021 Sep-Oct;41(5):693-700. doi: 10.11607/prd.5136.
PubMed 34547072
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunnel Access for Ridge Augmentation Using Xenogenous Bone, Hyaluronic Acid and Acellular Dermal Matrix
- ClinicalTrials.gov ID
- NCT05475730
- Acronym / sponsor ID
- 2022
- Conditions
- Bone Loss, Implant Site Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- D'Albis DentalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Minimally invasive procedures with the tunnel technique have been suggested to decrease patient post-operative discomfort and morbidity in oral bone regeneration. In the ridge augmentation tunnel technique, crestal incision and the release of the connective tissue are avoided in order to enhance the blood supply of the flap. This approach preserves the blood circulation and does not damage the periosteum The purpose of this study is to evaluate the clinical outcome of a minimally invasive technique for maxillofacial horizontal bone augmentation .
performed by using a collagen dermal matrix, deproteinized bovine bone and hyaluronic acid.
Collagen matrix is inserted into a sub-periosteal tunnel using microsurgical instruments. Deproteinized bovine bone in a hyaluronic acid carrier are placed and inserted repeatedly into the pocket and absorbable suture is used to close the vertical incision.
Detailed description
Tunnel bone regeneration achieves treatment objectives using the least invasive surgical approach.The goal is to increase patient satisfaction, decrease post-operative discomfort and morbidity.Preservation of the integrity of the periosteum is a determining factor in reducing postoperative pain and improving wound vascularization.
The present study value the clinical results of a subperiosteal minimally invasive ridge horizontal augmentation technique.
The technique includes the use of a laparoscopic approach to deliver hyaluronic acid,xenograft and a dermal matrix into a subperiosteal pouch.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone regeneration | Experimental | Procedure: bone and soft tissue augmentationMinimally invasive horizontal bone augmentation using hyaluronic acid, deproteinized bovine bone and dermal matrix. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Patients had to be healthy according to System of the American Society of Anesthesiology (ASA) and aged 18 years or older
Key exclusion criteria (5 listed)
- smoking of more than 15 cigarettes a day
- untreated periodontal disease
- pregnancy or breastfeeding at date of inclusion
- acute infections
- keratinized mucosal tissue less than 2 mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone and soft tissue augmentationAlso: Bone regenerationA vertical full-thickness incision in the mesial aspect of the defect ridge.Microsurgery instruments is subsequently use to carefully elevate the full thickness of the mucosa. Extreme caution must be exercised during these maneuvers to avoid tissue perforation and to maintain the integrity of the periosteum.An dermal matrix is place into the tunnel.A pouch is create between the bone and the membrane and the mixed bone chips and hyaluronic acid are inserted into the tunnel until the desirable ridge dimensions are obtained. Primary closure of the vertical incisions was achieved with single interrupted sutures. | Procedure or surgery | Bone regeneration |
Primary outcome
Augmented tissue volume
Time frame: 7 month
The edentulous ridge will be scanned with an intraoral scan 3 times. First time: Initial situation. Second time: 5 months after regeneration. Third time: After implant placement. Will be evaluate the 3 scan in a cad-cam software to evaluate the ridge three-dimensional changes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 17912961Kfir E, Kfir V, Eliav E, Kaluski E. Minimally invasive guided bone regeneration. J Oral Implantol. 2007;33(4):205-10. doi: 10.1563/1548-1336(2007)33[205:MIGBR]2.0.CO;2.
- Results publication: PubMed 32032406Karmon B, Tavelli L, Rasperini G. Tunnel Technique with a Subperiosteal Bag for Horizontal Ridge Augmentation. Int J Periodontics Restorative Dent. 2020 Mar/Apr;40(2):223-230. doi: 10.11607/prd.4508.
- Results publication: PubMed 34547072Rasperini G, Tavelli L, Barootchi S, Karmon B. Tunnel Technique with a Subperiosteal Bag for Ridge Augmentation: A Case Series. Int J Periodontics Restorative Dent. 2021 Sep-Oct;41(5):693-700. doi: 10.11607/prd.5136.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe D'Albis study director
D'Albis Dental
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone and soft tissue augmentation in people with Bone Loss and Implant Site Injury, run by D'Albis Dental 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?
The sponsor lists 6 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 3 May 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Augmented tissue volume (time frame: 7 month). 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 NCT05475730, which also lists 3 linked publications.
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 3 May 2023.