NCT07427784

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
59mo left

Started Mar 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Mar 2031

First Submitted

Initial submission to the registry

February 6, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

March 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

February 6, 2026

Last Update Submit

March 18, 2026

Conditions

Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Esthetic evaluation

    From tooth extraction to 5 years of follow-up

  • Implant success rate

    From tooth extraction to 5 years of follow up

  • Implant survival rate

    From tooth extraction to 5 years follow up

  • Prosthesis success rate

    From tooth extraction to 5 years of follow up

  • Prosthesis survival rate

    From tooth extraction to 5 years of follow up

  • +8 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of the Sacred Heart

Roma, 00168, Italy

Location

Related Publications (3)

  • 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.

    PMID: 40762250RESULT

  • 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.

    PMID: 18546808RESULT

  • 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.

    PMID: 15691354RESULT

Study Officials

  • Carlo Lajolo

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Lajolo, MD, DDS

CONTACT

3356078354carlo.lajolo@unicatt.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Last Updated

March 20, 2026

Record last verified: 2026-02

Locations

IT(1)