NCT06862505

Brief Summary

The aim of this study is to evaluate the histologically analysis in humans and the orientation of collagen fibers around screw-less, morse taper implant-abutment connection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

February 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

February 25, 2025

Last Update Submit

March 3, 2025

Conditions

Implant TherapyBiological Width

Keywords

Dental implantsBiological widthIstological analysis

Outcome Measures

Primary Outcomes (1)

  • Histological analisys

    Histological analysis of peri-implant gengivaat 8 and 16 weeks to assess collagen fibre orientation

    8 and 16 weeks

Secondary Outcomes (1)

  • Histomorphometry

    8 and 16 weeks

Study Arms (2)

Biopsy at 8 weeks

EXPERIMENTAL
Procedure: Biopsy

Biopsy at 16 weeks

ACTIVE COMPARATOR
Procedure: Biopsy

Interventions

BiopsyPROCEDURE

Biopsy of soft tissue were taken randomly at 8 or 16 weeks to compare soft tissue

Biopsy at 16 weeksBiopsy at 8 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older, affected by partial edentulism of posterior elements need for at least two single implant rehabilitations
  • able to understand a sign an informed consent

You may not qualify if:

  • Peapole having a systemic or local contraindications for implant placement;
  • Untreated periodontal disease;
  • smokers;
  • osteoporosis;
  • uncontrolled diabetes;
  • refusal to implant rehabilitation;
  • refusal to biopsy collection;
  • systemic pathologies that could compromise the healing of peri-implant tissues.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rome

Rome, Italy, Italy

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 6, 2025

Study Start

February 15, 2024

Primary Completion

September 1, 2024

Study Completion

February 3, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)