NCT06500923

Brief Summary

To present the 5-year clinical, radiographic, and aesthetic outcomes in patients with congenitally missing lateral incisors (MLIs) rehabilitated with two narrow-diameter implants (NDIs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

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

August 1, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

5.4 years

First QC Date

July 8, 2024

Last Update Submit

July 8, 2024

Conditions

Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

  • Peri-implant marginal bone level changes

    Changes in mm at the 1-year follow-up visit

    1 year

Secondary Outcomes (3)

  • Implant Survival rate (%)

    1-3-5 year

  • Aesthetic outcomes

    1-3-5 year

  • PROMs

    1-3-5 year

Study Arms (2)

Ø2.9mm (Test)

Test patients have received a 2.9 Ø dental implant

Other: Oral rehabilitation by means of implant-supported single unit crowns

Ø3.3mm (Control)

Control patients have received a 3.3 Ø dental implant

Other: Oral rehabilitation by means of implant-supported single unit crowns

Interventions

Oral rehabilitation by means of implant-supported single unit crownsOTHER

Surgery: Implant placement; Prothetic rehabilitation: single unit crown

Ø2.9mm (Test)Ø3.3mm (Control)

Eligibility Criteria

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

Patients affected by congenital missing with uni- or bilateral maxillary lateral incisors (i.e. 12 and/or 22)

You may qualify if:

  • Patients affected by congenital missing with uni- or bilateral maxillary lateral incisors (i.e. 12 and/or 22)
  • Patients with systemic health or controlled medical conditions
  • Patients arrested skeletal growth as documented by two body height measurements at least one year apart not indicating continuous growth (Jensen, 2019)
  • Written Informed Consent

You may not qualify if:

  • Patients contraindications to implant therapy (Hwang \& Wang, 2006, 2007) including
  • Heavy smoking: \>20 cigarettes/day
  • Poor oral hygiene
  • Compromised compliance
  • Periodontally compromised conditions
  • Patients with MLI's with the canine situated in the MLI region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Copenhagen

Copenhagen, Denmark

Location

Study Officials

  • Simon Storgaard Jensen, Prof.

    Copenhagen University Hospital, Copenhagen, Denmark

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 15, 2024

Study Start

August 1, 2016

Primary Completion

December 31, 2021

Study Completion

June 15, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)