Alveolar Ridge PreservationNCT06970184
Alveolar Ridge Preservation With Cortico-cancellous Porcine Bone
An observational study of Alveolar Ridge Preservation and Implant Therapy, run by University of Pisa at 1 site in Italy.
Trial summary
Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Ridge Preservation, Implant Therapy, Tooth Extraction Site Healing
- What is being tested?
- tooth extraction with alveolar ridge preservation and Implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2021to 1 Jun 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring hopeless tooth extraction followed by ARP and implant-prosthetic rehabilitation
Who may be able to join
- 18 yo
- Needing tooth extraction followed by ARP and implant-prosthetic rehabilitation
Who cannot join
- uncontrolled systemic diseases
- uncontrolled periodontitis
- undergoing previous or actual treatment with medications/radiations potentially impairing hard and soft tissues healing
- women during pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O. Odontostomatologia e Chirurgia del Cavo Orale
Pisa, Italy, 56126
About this study
Official title: Alveolar Ridge Preservation With Cortico-cancellous Collagenic Porcine Bone
Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement.
Read the detailed description
The primary aim of this study is to compare the histomorphometric characteristics of two different formulations of CCPB used for ARP, and the secondary aim is to evaluate and compare clinical and aesthetic outcomes of dental implants placed in augmented sites.
Patients requiring the extraction of an hopeless tooth followed by ARP and subsequent implant placement are considered potentially eligible for the study.
At T0, Tooth extractions are performed trying to reduce the surgical trauma as possible. ARP is performed with 2 different combinations of a cortico-cancellous porcine bone with a thermogel (50:50 ratio, hand-mixed or 80:20 ratio, pre-mixed).
After 4 months of healing, patients undergo a radiographic examination before implant placement.
A T1, Implant site preparation is carried out using a trephine bur (to remove a core biopsy of the bone) followed by conventional osteotomy drills, and bone-level implants are placed. Bone samples are analyzed to evaluate new bone formation, presence of residual graft particles and marrow spaces.
Three months after placement, all implants are rehabilitated with screw-retained prosthetic crowns (T2).
Follow up is scheduled 1 year after prosthetic loading (T3).
- Being tested
- tooth extraction with alveolar ridge preservation, Implant placement
- Keywords
- ARP, tooth extraction, dental implants, porcine bone, collagen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth extraction with alveolar ridge preservationProcedure or surgery
alveolar ridge preservation performed after tooth extraction
Implant placementProcedure or surgery
Implant placement
| Study group | Role | What they receive |
|---|---|---|
| ARP 50:50 | Tooth extraction + ARP with collagenated porcine bone hand-mixed (ratio 50:50) with a thermogel Receives: Procedure: tooth extraction with alveolar ridge preservation; Procedure: Implant placement | |
| ARP 80:20 | Tooth extraction + ARP with collagenated porcine bone pre-mixed (ratio 80:20) with a thermogel Receives: Procedure: tooth extraction with alveolar ridge preservation; Procedure: Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric characteristics of the bone: Newly formed bone (NB)
The primary outcome is evaluated in terms of Percentages of newly formed bone (NB) in the in the histological samples.
Measured: T1= 4 months following tooth extraction + ARP
Histomorphometric characteristics of the bone: marrow spaces (MS)
The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
Measured: T1= 4 months following tooth extraction + ARP
Histomorphometric characteristics of the bone: residual graft particles (RP)
The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
Measured: T1= 4 months following tooth extraction + ARP
Secondary outcomes (9)
Marginal Bone Level
Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact.
Measured: T1= 4 months following tooth extraction + ARP
Marginal Bone Level
Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact.
Measured: T2= 3 months following implant placement
Marginal Bone Level
Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact.
Measured: T3= 1-year follow-up
Horizontal alveolar measure
Maximum post-extractive buccal/lingual distance (measured in millimeters) of the socket evaluated with a UNC periodontal probe
Measured: Day 1 = tooth extraction + ARP
Horizontal alveolar measure
Maximum alveolar crest width at implant placement (measured in millimeters) evaluated with a UNC periodontal probe
Measured: T1= 4 months following tooth extraction + ARP
Vertical alveolar measure
Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe
Measured: Day 1 = tooth extraction + ARP
Vertical alveolar measure
Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe
Measured: T1= 4 months following tooth extraction + ARP
Aesthetic outcomes
evaluated with the Pink Esthetic Score (PES) according to seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar ridge deficiency, soft tissue color, and soft tissue texture. Each variable could have a score ranging between 0 to 2; the total PES has a maximum level of 14
Measured: T2= 3 months following implant placement
Aesthetic outcomes
evaluated with the Pink Esthetic Score (PES) according to seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar ridge deficiency, soft tissue color, and soft tissue texture. Each variable could have a score ranging between 0 to 2; the total PES has a maximum level of 14
Measured: T3= 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start15 Jun 2021
- Primary completion1 Jul 2023
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Barone, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970184
- Sponsor's protocol ID
- BONEISTO_ARP
- Status last verified
- May 2025
- First submitted
- 23 Apr 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation With Cortico-cancellous Collagenic Porcine Bone
- ClinicalTrials.gov ID
- NCT06970184
- Acronym / sponsor ID
- BONEISTO_ARP
- Keywords
- ARP, tooth extraction, dental implants, porcine bone, collagen
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 14 May 2025 (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.
Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement.
Detailed description
The primary aim of this study is to compare the histomorphometric characteristics of two different formulations of CCPB used for ARP, and the secondary aim is to evaluate and compare clinical and aesthetic outcomes of dental implants placed in augmented sites.
Patients requiring the extraction of an hopeless tooth followed by ARP and subsequent implant placement are considered potentially eligible for the study.
At T0, Tooth extractions are performed trying to reduce the surgical trauma as possible. ARP is performed with 2 different combinations of a cortico-cancellous porcine bone with a thermogel (50:50 ratio, hand-mixed or 80:20 ratio, pre-mixed).
After 4 months of healing, patients undergo a radiographic examination before implant placement.
A T1, Implant site preparation is carried out using a trephine bur (to remove a core biopsy of the bone) followed by conventional osteotomy drills, and bone-level implants are placed. Bone samples are analyzed to evaluate new bone formation, presence of residual graft particles and marrow spaces.
Three months after placement, all implants are rehabilitated with screw-retained prosthetic crowns (T2).
Follow up is scheduled 1 year after prosthetic loading (T3).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARP 50:50 | – | Procedure: tooth extraction with alveolar ridge preservation, Procedure: Implant placementTooth extraction + ARP with collagenated porcine bone hand-mixed (ratio 50:50) with a thermogel |
| ARP 80:20 | – | Procedure: tooth extraction with alveolar ridge preservation, Procedure: Implant placementTooth extraction + ARP with collagenated porcine bone pre-mixed (ratio 80:20) with a thermogel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring hopeless tooth extraction followed by ARP and implant-prosthetic rehabilitation
Key inclusion criteria (2 listed)
- 18 yo
- Needing tooth extraction followed by ARP and implant-prosthetic rehabilitation
Key exclusion criteria (4 listed)
- uncontrolled systemic diseases
- uncontrolled periodontitis
- undergoing previous or actual treatment with medications/radiations potentially impairing hard and soft tissues healing
- women during pregnancy or breastfeeding
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 |
|---|---|---|
| tooth extraction with alveolar ridge preservationalveolar ridge preservation performed after tooth extraction | Procedure or surgery | ARP 50:50, ARP 80:20 |
| Implant placementImplant placement | Procedure or surgery | ARP 50:50, ARP 80:20 |
Primary outcome
Histomorphometric characteristics of the bone: Newly formed bone (NB)
Time frame: T1= 4 months following tooth extraction + ARP
The primary outcome is evaluated in terms of Percentages of newly formed bone (NB) in the in the histological samples.
Histomorphometric characteristics of the bone: marrow spaces (MS)
Time frame: T1= 4 months following tooth extraction + ARP
The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
Histomorphometric characteristics of the bone: residual graft particles (RP)
Time frame: T1= 4 months following tooth extraction + ARP
The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
9 secondary outcomes
Marginal Bone Level
Time frame: T1= 4 months following tooth extraction + ARP
Marginal Bone Level
Time frame: T2= 3 months following implant placement
Marginal Bone Level
Time frame: T3= 1-year follow-up
Horizontal alveolar measure
Time frame: Day 1 = tooth extraction + ARP
Horizontal alveolar measure
Time frame: T1= 4 months following tooth extraction + ARP
Vertical alveolar measure
Time frame: Day 1 = tooth extraction + ARP
Vertical alveolar measure
Time frame: T1= 4 months following tooth extraction + ARP
Aesthetic outcomes
Time frame: T2= 3 months following implant placement
Aesthetic outcomes
Time frame: T3= 1-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Ridge Preservation and Implant Therapy, run by University of Pisa 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 20 May 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?
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?
Histomorphometric characteristics of the bone: Newly formed bone (NB) (time frame: T1= 4 months following tooth extraction + ARP). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.