NCT02401789

Brief Summary

The objective of the present study is to evaluate if loss of multiple adjacent teeth will cause proportionally greater tissue diminution than the loss of single teeth the possibility of counteracting unfavourable ridge modeling after multiple tooth extractions by placing implants in the fresh extraction sites soft tissue alterations at implants and adjacent teeth

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

8.3 years

First QC Date

March 16, 2015

Last Update Submit

February 28, 2023

Conditions

Multiple Adjacent TeethBone Remodelling

Keywords

oral surgeryImplantology

Outcome Measures

Primary Outcomes (6)

  • Measurements of the change of the bone in between 2 or more teeth reported in millimeters after 6 month of the extraction in relation to the amount of the buccal-lingual reduction

    6 month.

  • Measurements of the change of the bone in between 2 or more teeth reported in millimeters after 6 month of the extraction in relation to the amount of the buccal-lingual reduction

    1 year

  • Measurements of the change of the bone in between 2 or more teeth reported in millimeters after 6 month of the extraction in relation to the amount of the buccal-lingual reduction

    2 year

  • Measurements of the change of the bone in between 2 or more teeth reported in millimeters after 6 month of the extraction in relation to the amount of the buccal-lingual reduction

    3 year

  • Measurements of the change of the bone in between 2 or more teeth reported in millimeters after 6 month of the extraction in relation to the amount of the buccal-lingual reduction

    4 year

  • Measurements of the change of the bone in between 2 or more teeth reported in millimeters after 6 month of the extraction in relation to the amount of the buccal-lingual reduction

    5 year

Study Arms (2)

test - implant placement

EXPERIMENTAL

The possibility of counteracting unfavourable ridge modelling after multiple tooth extractions by placing implants in the fresh extraction sites

Device: Implants (OsseospeedTM,EV Astra Tech System, DentsplyTM, Mölndal)

control- natural healing

NO INTERVENTION

Interventions

Implants (OsseospeedTM,EV Astra Tech System, DentsplyTM, Mölndal)DEVICE
test - implant placement

Eligibility Criteria

Age25 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of an intact extraction socket following removal of the natural teeth defined by: a marginal dehiscence defect of the facial bone wall of \< 3 mm no facial fenestration present apical of the marginal bone crest

You may not qualify if:

  • Untreated rampant caries and uncontrolled periodontal disease Uncontrolled diabetes or any other systemic or local disease or condition that would compromise post-operative healing Unable or unwilling to return for follow-up or unlikely to be able to comply with study procedures according to investigators judgement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franci Institute

Padua, 35121, Italy

Location

Related Publications (1)

  • References Araújo, M, F Sukekava, J Wennström and J Lindhe (2006).

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dimensional alterations of the edentulous ridge following removal of multiple adjacent teeth.

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 30, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2023

Study Completion

December 1, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

IT(1)