Clinical and Radiographic Outcomes of Alveolar Ridge Preservation (REGSYST)

March 18, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Uncontrolled diabetes or hypertension;
  • Uncontrolled periodontal disease;
  • Inability to perform consistent and continuous follow-up;
  • Pregnancy or breastfeeding;
  • Inability to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From tooth extraction to 6 months of follow up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Esthetic evaluation
Time Frame: From tooth extraction to 5 years of follow-up
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.
From tooth extraction to 5 years of follow-up
Implant success rate
Time Frame: From tooth extraction to 5 years of follow up
Absence of biological and technical complications, expressed as a proportion
From tooth extraction to 5 years of follow up
Implant survival rate
Time Frame: From tooth extraction to 5 years follow up
Rate of dental implants remaining in situ, measured as a proportion
From tooth extraction to 5 years follow up
Prosthesis success rate
Time Frame: From tooth extraction to 5 years of follow up
Absence of technical complications, expressed as a proportion
From tooth extraction to 5 years of follow up
Prosthesis survival rate
Time Frame: From tooth extraction to 5 years of follow up
Rate of prostheses remaining in situ, expressed as a proportion
From tooth extraction to 5 years of follow up
Patient-Reported Outcome Measures
Time Frame: From tooth extraction to 5 years of follow up
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
From tooth extraction to 5 years of follow up
Diabetes
Time Frame: From tooth extraction to 5 years of follow up
Analysis of the influence of diabetes (assessed as presence/absence) as potential risk factor during follow-up
From tooth extraction to 5 years of follow up
Glycated hemoglobin level
Time Frame: From tooth extraction to 5 years of follow up
Analysis of glycated hemoglobin levels recorded at baseline and during follow-up
From tooth extraction to 5 years of follow up
Complete Blood Count
Time Frame: From tooth extraaction to 5 years of follow up
Analysis of the influence of complete blood count parameters
From tooth extraaction to 5 years of follow up
Histologic analysis
Time Frame: From tooth extraction to 6 months of follow up
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)
From tooth extraction to 6 months 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 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).
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 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).
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
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).
From tooth extraction to 5 years of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carlo Lajolo, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alveolar Ridge Preservation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings