NCT06970184

Brief Summary

Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

June 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

April 23, 2025

Last Update Submit

May 14, 2025

Conditions

Keywords

ARPtooth extractiondental implantsporcine bonecollagen

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

Procedure: tooth extraction with alveolar ridge preservationProcedure: Implant placement

ARP 80:20

Tooth extraction + ARP with collagenated porcine bone pre-mixed (ratio 80:20) with a thermogel

Procedure: tooth extraction with alveolar ridge preservationProcedure: Implant placement

Interventions

alveolar ridge preservation performed after tooth extraction

ARP 50:50ARP 80:20

Implant placement

ARP 50:50ARP 80:20

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

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

Locations