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NCT Number: NCT07427784

Clinical and Radiographic Outcomes of Alveolar Ridge Preservation

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.

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Key information

Conditions

Alveolar Ridge Preservation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catholic University of the Sacred Heart

Roma, 00168, Italy

Location contact

Carlo Lajolo

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Implant success rate

    Time frame: From tooth extraction to 5 years of follow up

    Absence of biological and technical complications, expressed as a proportion

  3. Implant survival rate

    Time frame: From tooth extraction to 5 years follow up

    Rate of dental implants remaining in situ, measured as a proportion

  4. Prosthesis success rate

    Time frame: From tooth extraction to 5 years of follow up

    Absence of technical complications, expressed as a proportion

  5. Prosthesis survival rate

    Time frame: From tooth extraction to 5 years of follow up

    Rate of prostheses remaining in situ, expressed as a proportion

  6. 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

  7. 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

  8. 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

  9. 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).

  10. 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).

  11. 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).

  12. Complete Blood Count

    Time frame: From tooth extraaction to 5 years of follow up

    Analysis of the influence of complete blood count parameters

  13. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Carlo Lajolo, MD, DDS

CONTACT

[email protected]

3356078354

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Clinical and Radiographic Outcomes of Alveolar Ridge Preservation for Implant-prosthetic Rehabilitation in a Hospital Setting: a Prospective Study

Acronym: REGSYST

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Feb 23, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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