Clinical and Radiographic Outcomes of Alveolar Ridge Preservation (REGSYST)

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: Not yet recruiting
• Conditions: Alveolar Ridge Preservation

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Carlo Lajolo, MD, DDS; Phone Number: 3356078354; Email: carlo.lajolo@unicatt.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Catholic University of the Sacred Heart
    • Contact: Carlo Lajolo; Email: carlo.lajolo@unicatt.it

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
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.	From tooth extraction to 6 months of follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From tooth extraction to 5 years of follow-up
Implant success rate	Absence of biological and technical complications, expressed as a proportion	From tooth extraction to 5 years of follow up
Implant survival rate	Rate of dental implants remaining in situ, measured as a proportion	From tooth extraction to 5 years follow up
Prosthesis success rate	Absence of technical complications, expressed as a proportion	From tooth extraction to 5 years of follow up
Prosthesis survival rate	Rate of prostheses remaining in situ, expressed as a proportion	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	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	From tooth extraction to 5 years of follow up
Glycated hemoglobin level	Analysis of glycated hemoglobin levels recorded at baseline and during follow-up	From tooth extraction to 5 years of follow up
Complete Blood Count	Analysis of the influence of complete blood count parameters	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)	From tooth extraction to 6 months 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).	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).	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).	From tooth extraction to 5 years of follow up

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Carlo Lajolo, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

General Publications

• Araujo 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.
• 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.
• Araujo 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID 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