Alveolar Ridge Preservation With Cortico-cancellous Porcine Bone
1 other identifier
observational
22
1 country
1
Brief Summary
Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 23, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMay 20, 2025
May 1, 2025
2 years
April 23, 2025
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Histomorphometric characteristics of the bone: Newly formed bone (NB)
The primary outcome is evaluated in terms of Percentages of newly formed bone (NB) in the in the histological samples.
T1= 4 months following tooth extraction + ARP
Histomorphometric characteristics of the bone: marrow spaces (MS)
The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
T1= 4 months following tooth extraction + ARP
Histomorphometric characteristics of the bone: residual graft particles (RP)
The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
T1= 4 months following tooth extraction + ARP
Secondary Outcomes (9)
Marginal Bone Level
T1= 4 months following tooth extraction + ARP
Marginal Bone Level
T2= 3 months following implant placement
Marginal Bone Level
T3= 1-year follow-up
Horizontal alveolar measure
Day 1 = tooth extraction + ARP
Horizontal alveolar measure
T1= 4 months following tooth extraction + ARP
- +4 more secondary outcomes
Study Arms (2)
ARP 50:50
Tooth extraction + ARP with collagenated porcine bone hand-mixed (ratio 50:50) with a thermogel
ARP 80:20
Tooth extraction + ARP with collagenated porcine bone pre-mixed (ratio 80:20) with a thermogel
Interventions
alveolar ridge preservation performed after tooth extraction
Eligibility Criteria
Patients requiring hopeless tooth extraction followed by ARP and implant-prosthetic rehabilitation
You may qualify if:
- Needing tooth extraction followed by ARP and implant-prosthetic rehabilitation
You may not qualify if:
- uncontrolled systemic diseases
- uncontrolled periodontitis
- undergoing previous or actual treatment with medications/radiations potentially impairing hard and soft tissues healing
- women during pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
U.O. Odontostomatologia e Chirurgia del Cavo Orale
Pisa, Italy, 56126, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
April 23, 2025
First Posted
May 14, 2025
Study Start
June 15, 2021
Primary Completion
July 1, 2023
Study Completion
June 1, 2025
Last Updated
May 20, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share