Alveolar Ridge PreservationREGSYSTNCT07427784
Clinical and Radiographic Outcomes of Alveolar Ridge Preservation
An observational study of Alveolar Ridge Preservation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Dental implants are considered a predictable rehabilitative option following tooth extraction or in cases of missing teeth. In some situations, the inevitable alveolar ridge resorption that occurs after extraction may make the placement of standard-diameter (>3.5 mm) or standard-length implants difficult or even… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Ridge Preservation
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2026to 1 Mar 2031
- 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 aged 18 years and older requiring bone regeneration with an alveolar ridge preservation technique prior to implant rehabilitation will be included in the study.
Who may be able to join
- Patients requiring alveolar ridge preservation procedures prior to implant rehabilitation of edentulous sites;
- Age > 18;
- Achievement of FMPS and FMBS ≤ 15%;
- Signed written informed consent to participate in the study.
Who cannot join
- Uncontrolled diabetes or hypertension;
- Uncontrolled periodontal disease;
- Inability to perform consistent and continuous follow-up;
- Pregnancy or breastfeeding;
- Inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Catholic University of the Sacred Heart
Roma, 00168
Carlo Lajolo, carlo.lajolo@unicatt.it
About this study
Official title: Clinical and Radiographic Outcomes of Alveolar Ridge Preservation for Implant-prosthetic Rehabilitation in a Hospital Setting: a Prospective Study
Dental implants are considered a predictable rehabilitative option following tooth extraction or in cases of missing teeth. In some situations, the inevitable alveolar ridge resorption that occurs after extraction may make the placement of standard-diameter (>3.5 mm) or standard-length implants difficult or even impossible without advanced bone augmentation procedures. To counteract post-extraction volumetric bone contraction, alveolar ridge preservation can be performed, consisting of placing a bone graft within the socket walls immediately after tooth extraction. Although this procedure cannot completely prevent dimensional changes, it has been shown to significantly reduce both horizontal and vertical ridge resorption, as reported in the scientific literature. However, there is a lack of clinical and radiographic studies evaluating the outcomes of implant rehabilitation following alveolar ridge preservation with standard-dimension implants in a hospital-based setting.
- Conditions
- Alveolar Ridge Preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge preservation | Patients aged 18 years and older requiring tooth extraction followed by alveolar ridge preservation to enable implant surgery and prosthetic rehabilitation of edentulous sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric analysis
The dimensional change of hard tissues following bone regenerative procedures will be assessed radiographically by measuring horizontal and vertical bone resorption through CBCT comparison in patients treated in a hospital-based setting.
Measured: From tooth extraction to 6 months of follow up.
Secondary outcomes (13)
Esthetic evaluation
Assessed using the PES/WES esthetic index. Scores range from 0 to 14 for the PES and from 0 to 10 for the WES, with higher scores indicating better esthetic outcomes.
Measured: From tooth extraction to 5 years of follow-up
Implant success rate
Absence of biological and technical complications, expressed as a proportion
Measured: From tooth extraction to 5 years of follow up
Implant survival rate
Rate of dental implants remaining in situ, measured as a proportion
Measured: From tooth extraction to 5 years follow up
Prosthesis success rate
Absence of technical complications, expressed as a proportion
Measured: From tooth extraction to 5 years of follow up
Prosthesis survival rate
Rate of prostheses remaining in situ, expressed as a proportion
Measured: From tooth extraction to 5 years of follow up
Patient-Reported Outcome Measures
Recorded using a specifically designed questionnaire and measured with a visual analogue scale (VAS) ranging from 0 to 10, with higher scores indicating better outcomes
Measured: From tooth extraction to 5 years of follow up
Diabetes
Analysis of the influence of diabetes (assessed as presence/absence) as potential risk factor during follow-up
Measured: From tooth extraction to 5 years of follow up
Glycated hemoglobin level
Analysis of glycated hemoglobin levels recorded at baseline and during follow-up
Measured: From tooth extraction to 5 years of follow up
Correlation of medications relevant to bone/soft tissue metabolism with implant health
Correlation between exposure to medications affecting bone and soft tissue metabolism and peri-implant marginal bone loss (measured in millimeters on standardized periapical radiographs) and implant success (defined as the absence of complications).
Measured: From tooth extraction to 5 years of follow up
Correlation between osteoporosis status and implant health
Correlation between osteoporosis status (DXA T-score/ICD diagnosis) and peri-implant marginal bone loss (measured in millimeters on standardized periapical radiographs) and implant success (defined as the absence of complications).
Measured: From tooth extraction to 5 years of follow up
Correlation between cardiovascular disease and implant health
Correlation between cardiovascular diseases and peri-implant marginal bone loss (measured in millimeters on standardized periapical radiographs) and implant success (defined as the absence of complications).
Measured: From tooth extraction to 5 years of follow up
Complete Blood Count
Analysis of the influence of complete blood count parameters
Measured: From tooth extraaction to 5 years of follow up
Histologic analysis
Histomorphometric analysis of hard and soft tissues on stained histologic sections (% new bone, residual graft, epithelial thickness, keratin layer thickness, inflammatory infiltrate, collagen organization, and vascular density)
Measured: From tooth extraction to 6 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2031 (estimated)
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 Alveolar Ridge PreservationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Lajolo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427784
- Sponsor's protocol ID
- 8085
- Acronym
- REGSYST
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sandoli Arroteia L, Lopes MP, Rea MT, Vieira E Oliveira TR, Oliveira ML, de Faveri M, Santamaria MP, Queiroz LA, Casati MZ, Casarin RCV. Dimensional Changes After Different Alveolar Ridge Preservation Techniques for Posterior Region: A Randomised Controlled Clinical Trial. J Clin Periodontol. 2025 Nov;52(11):1584-1594. doi: 10.1111/jcpe.70004. Epub 2025 Aug 5.
PubMed 40762250Araujo M, Linder E, Wennstrom J, Lindhe J. The influence of Bio-Oss Collagen on healing of an extraction socket: an experimental study in the dog. Int J Periodontics Restorative Dent. 2008 Apr;28(2):123-35.
PubMed 18546808Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Alveolar Ridge Preservation for Implant-prosthetic Rehabilitation in a Hospital Setting: a Prospective Study
- ClinicalTrials.gov ID
- NCT07427784
- Acronym / sponsor ID
- REGSYST / 8085
- Conditions
- Alveolar Ridge Preservation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 23 Feb 2026 (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.
Dental implants are considered a predictable rehabilitative option following tooth extraction or in cases of missing teeth. In some situations, the inevitable alveolar ridge resorption that occurs after extraction may make the placement of standard-diameter (>3.5 mm) or standard-length implants difficult or even impossible without advanced bone augmentation procedures. To counteract post-extraction volumetric bone contraction, alveolar ridge preservation can be performed, consisting of placing a bone graft within the socket walls immediately after tooth extraction. Although this procedure cannot completely prevent dimensional changes, it has been shown to significantly reduce both horizontal and vertical ridge resorption, as reported in the scientific literature. However, there is a lack of clinical and radiographic studies evaluating the outcomes of implant rehabilitation following alveolar ridge preservation with standard-dimension implants in a hospital-based setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge preservation | – | –Patients aged 18 years and older requiring tooth extraction followed by alveolar ridge preservation to enable implant surgery and prosthetic rehabilitation of edentulous sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older requiring bone regeneration with an alveolar ridge preservation technique prior to implant rehabilitation will be included in the study.
Key inclusion criteria (4 listed)
- Patients requiring alveolar ridge preservation procedures prior to implant rehabilitation of edentulous sites;
- Age > 18;
- Achievement of FMPS and FMBS ≤ 15%;
- Signed written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Uncontrolled diabetes or hypertension;
- Uncontrolled periodontal disease;
- Inability to perform consistent and continuous follow-up;
- Pregnancy or breastfeeding;
- Inability to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volumetric analysis
Time frame: From tooth extraction to 6 months of follow up.
The dimensional change of hard tissues following bone regenerative procedures will be assessed radiographically by measuring horizontal and vertical bone resorption through CBCT comparison in patients treated in a hospital-based setting.
13 secondary outcomes
Esthetic evaluation
Time frame: From tooth extraction to 5 years of follow-up
Implant success rate
Time frame: From tooth extraction to 5 years of follow up
Implant survival rate
Time frame: From tooth extraction to 5 years follow up
Prosthesis success rate
Time frame: From tooth extraction to 5 years of follow up
Prosthesis survival rate
Time frame: From tooth extraction to 5 years of follow up
Patient-Reported Outcome Measures
Time frame: From tooth extraction to 5 years of follow up
Diabetes
Time frame: From tooth extraction to 5 years of follow up
Glycated hemoglobin level
Time frame: From tooth extraction to 5 years of follow up
Correlation of medications relevant to bone/soft tissue metabolism with implant health
Time frame: From tooth extraction to 5 years of follow up
Correlation between osteoporosis status and implant health
Time frame: From tooth extraction to 5 years of follow up
Correlation between cardiovascular disease and implant health
Time frame: From tooth extraction to 5 years of follow up
Complete Blood Count
Time frame: From tooth extraaction to 5 years of follow up
Histologic analysis
Time frame: From tooth extraction to 6 months of 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 Mar 2026.
- Results publication: PubMed 40762250Sandoli Arroteia L, Lopes MP, Rea MT, Vieira E Oliveira TR, Oliveira ML, de Faveri M, Santamaria MP, Queiroz LA, Casati MZ, Casarin RCV. Dimensional Changes After Different Alveolar Ridge Preservation Techniques for Posterior Region: A Randomised Controlled Clinical Trial. J Clin Periodontol. 2025 Nov;52(11):1584-1594. doi: 10.1111/jcpe.70004. Epub 2025 Aug 5.
- Results publication: PubMed 18546808Araujo M, Linder E, Wennstrom J, Lindhe J. The influence of Bio-Oss Collagen on healing of an extraction socket: an experimental study in the dog. Int J Periodontics Restorative Dent. 2008 Apr;28(2):123-35.
- Results publication: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Individual participant dataSharing planned: Undecided
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Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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Effect of Collagen Membrane on Ridge Preservation
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Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
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Biotivity A-C Membrane Socket Preservation Study
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Vallomix Socket Preservation Study
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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.
Carlo Lajolo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 4 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: opening soon, as of the sponsor's last update on 20 Mar 2026. 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?
Contact Carlo Lajolo, MD, DDS (3356078354, carlo.lajolo@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric analysis (time frame: From tooth extraction to 6 months of follow up.). 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 NCT07427784, 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 20 Mar 2026.