Narrow-diameter Implants Replacing Maxillary Lateral Incisors

Five Year Outcomes at Two Narrow-diameter Implants to Replace Congenital Missing Maxillary Lateral Incisors

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).

Study Overview

• Status: Completed
• Conditions: Dental Implant Failed
• Intervention / Treatment: Other: Oral rehabilitation by means of implant-supported single unit crowns

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • University Hospital Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ø2.9mm (Test); Test patients have received a 2.9 Ø dental implant	Other: Oral rehabilitation by means of implant-supported single unit crowns; Surgery: Implant placement; Prothetic rehabilitation: single unit crown
Ø3.3mm (Control); Control patients have received a 3.3 Ø dental implant	Other: Oral rehabilitation by means of implant-supported single unit crowns; Surgery: Implant placement; Prothetic rehabilitation: single unit crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant marginal bone level changes	Changes in mm at the 1-year follow-up visit	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival rate (%)	Number of implants in situ over the number of placed implants	1-3-5 year
Aesthetic outcomes	Evaluation of the aesthetic outcomes by means of a dedicated Index (Copenhagen Index Score CPI) (Score 1-4 / Score 1: best outcome; 4 : worst outcome)	1-3-5 year
PROMs	OHIP - 49 Scale (Score 1-3) (Score 1: best outcome; 3 : worst outcome)	1-3-5 year

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: Copenhagen University Hospital, Denmark
• Investigators: Study Chair: Simon Storgaard Jensen, Prof., Copenhagen University Hospital, Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2012-58-0004 (Danish Data Protection Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No