Bone Atrophy, AlveolarNCT06424223
Tunnel Access for Horizontal Alveolar Ridge Augmentation
A study testing Horizontal Ridge augmentation in people with Bone Atrophy, Alveolar and Bone Loss, run by University of Bari Aldo Moro 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 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Atrophy, Alveolar, Bone Loss, Bone Resorption
- What is being tested?
- Horizontal Ridge 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 Nov 2022to 1 Nov 2024
- 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 18 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 Approach With Biphasic Calcium Phosphate and Acellular Dermal Matrix for Horizontal Ridge Augmentation.
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 .
Read the detailed description
Several techniques have been introduced to minimize the invasiveness involved in oral bone regeneration, to prevent the coronal advancement of the flap, which in turn reduces postoperative discomfort, swelling, complications, and mobility.
The tunnel technique involves making a vertical incision to access the bone defect and inserting the grafts. The significant benefit of this approach is that it may be closed without the need for periosteal incisions. Several tunnel techniques have been described in the literature using various biomaterials including bovine bone, synthetic bone, bovine bone block, allograft block bone, hidroxiapatite. This clinical study assesses the efficiency of a minimally invasive surgical technique for horizontal ridge augmentation using Biphasic Calcium Phosphate and Acellular Dermal Matrix.
This minimally invasive procedure aims to increase the horizontal volume of the edentulous ridge in both its bone component (through the use of Biphasic Calcium Phosphate) and its mucosal component (through the use of Acellular Dermal Matrix). Compared to other traditional techniques, this procedure, performed through a tunnel approach, would significantly reduce the invasiveness of the treatment.
- Conditions
- Bone Atrophy, Alveolar, Bone Loss, Bone Resorption, Alveolar Bone Loss, Alveolar Bone Resorption
- Being tested
- Horizontal Ridge augmentation
- Keywords
- Bone augmentation, Bone regeneration, Tissues augmentation, Ridge augmentation
- Medical subject headings
- Alveolar Bone Loss, Bone Diseases, Metabolic, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal Ridge augmentationProcedure or surgery
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 matrix and the Biphasic Calcium Phosphate is 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 |
|---|---|---|
| Ridge augmentation | Experimental | Not described Receives: Procedure: Horizontal Ridge augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the achievement of an adequate thickness of the alveolar ridge ridge
Digital intraoral casts will be superimposed to value the gained thickness of the ridge.
The assessment of volume increase in the alveolar ridge will be observed within the implant planning software by measuring the variation in the width of the edentulous ridge by matching three scans. The scans will be conducted at baseline (T0), five months after ridge augmentation (T1), and two months after implant insertion (T2). The matching will be performed using corresponding pairs of regions. The thickness of the alveolar ridges on the same cross-section at the level of the implants inserted will be measured in mm using the "distance" tool.
Measured: 5 months
Secondary outcomes (1)
Histological analysis of newly formed tissues.
A histological analysis will be conducted by the pathology laboratory of the Bari University Hospital on a bone biopsy taken at the same time as the implant placement.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Nov 2022
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Atrophy, AlveolarStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe D'Albis, University of Bari Aldo Moro
- Investigators
- Professor Saverio Capodiferro, Study director, University of Bari Aldo MoroProfessor Massimo Corsalini, Study director, University of Bari Aldo MoroDr. D'Albis Giuseppe, Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424223
- Sponsor's protocol ID
- Mini-invasiveRidgeAugmentation
- Status last verified
- Dec 2024
- First submitted
- 2 May 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
D'Albis G, Forte M, Marini L, Mustakim KR, Pilloni A, Corsalini M, Capodiferro S. Horizontal Ridge Augmentation with Xenogeneic Bone, Hyaluronic Acid, and Dermal Matrix by Tunnel Technique: A Case Series. Dent J (Basel). 2026 Jan 4;14(1):25. doi: 10.3390/dj14010025.
PubMed 41590149
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunnel Approach With Biphasic Calcium Phosphate and Acellular Dermal Matrix for Horizontal Ridge Augmentation.
- ClinicalTrials.gov ID
- NCT06424223
- Acronym / sponsor ID
- Mini-invasiveRidgeAugmentation
- Conditions
- Bone Atrophy, Alveolar, Bone Loss, Bone Resorption, Alveolar Bone Loss, Alveolar Bone Resorption
- Keywords
- Bone augmentation, Bone regeneration, Tissues augmentation, Ridge augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 22 May 2024 (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 .
Detailed description
Several techniques have been introduced to minimize the invasiveness involved in oral bone regeneration, to prevent the coronal advancement of the flap, which in turn reduces postoperative discomfort, swelling, complications, and mobility.
The tunnel technique involves making a vertical incision to access the bone defect and inserting the grafts. The significant benefit of this approach is that it may be closed without the need for periosteal incisions. Several tunnel techniques have been described in the literature using various biomaterials including bovine bone, synthetic bone, bovine bone block, allograft block bone, hidroxiapatite. This clinical study assesses the efficiency of a minimally invasive surgical technique for horizontal ridge augmentation using Biphasic Calcium Phosphate and Acellular Dermal Matrix.
This minimally invasive procedure aims to increase the horizontal volume of the edentulous ridge in both its bone component (through the use of Biphasic Calcium Phosphate) and its mucosal component (through the use of Acellular Dermal Matrix). Compared to other traditional techniques, this procedure, performed through a tunnel approach, would significantly reduce the invasiveness of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ridge augmentation | Experimental | Procedure: Horizontal Ridge augmentation |
Who may qualify
- Ages
- 18 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 (3 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 |
|---|---|---|
| Horizontal Ridge augmentationA 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 matrix and the Biphasic Calcium Phosphate is 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 | Ridge augmentation |
Primary outcome
Evaluation of the achievement of an adequate thickness of the alveolar ridge ridge
Time frame: 5 months
Digital intraoral casts will be superimposed to value the gained thickness of the ridge. The assessment of volume increase in the alveolar ridge will be observed within the implant planning software by measuring the variation in the width of the edentulous ridge by matching three scans. The scans will be conducted at baseline (T0), five months after ridge augmentation (T1), and two months after implant insertion (T2). The matching will be performed using corresponding pairs of regions. The thickness of the alveolar ridges on the same cross-section at the level of the implants inserted will be measured in mm using the "distance" tool.
1 secondary outcome
Histological analysis of newly formed tissues.
Time frame: 5 months
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 Jan 2025.
- Derived from this study: PubMed 41590149D'Albis G, Forte M, Marini L, Mustakim KR, Pilloni A, Corsalini M, Capodiferro S. Horizontal Ridge Augmentation with Xenogeneic Bone, Hyaluronic Acid, and Dermal Matrix by Tunnel Technique: A Case Series. Dent J (Basel). 2026 Jan 4;14(1):25. doi: 10.3390/dj14010025.
- Individual participant dataSharing planned: Undecided
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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.
Professor Saverio Capodiferro study director
University of Bari Aldo Moro
Professor Massimo Corsalini study director
University of Bari Aldo Moro
Dr. D'Albis Giuseppe principal investigator
University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizontal Ridge augmentation in people with Bone Atrophy, Alveolar and Bone Loss, run by University of Bari Aldo Moro 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 3 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 Jan 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.
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?
Evaluation of the achievement of an adequate thickness of the alveolar ridge ridge (time frame: 5 months). 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 NCT06424223, which also lists 1 linked publication.
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 Jan 2025.