Narrow-diameter Implants Replacing Maxillary Lateral Incisors

Completed

• Conditions: Dental Implant Failed
• Interventions: Other: Oral rehabilitation by means of implant-supported single unit crowns

• Registration Number: NCT06500923
• Lead Sponsor: University of Bern

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2021-12-31
• Study Completion: 2024-06-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ø3.3mm (Control)	Oral rehabilitation by means of implant-supported single unit crowns	Control patients have received a 3.3 Ø dental implant
Ø2.9mm (Test)	Oral rehabilitation by means of implant-supported single unit crowns	Test patients have received a 2.9 Ø dental implant

Primary Outcome Measures

Name	Time	Method
Peri-implant marginal bone level changes	1 year	Changes in mm at the 1-year follow-up visit

Secondary Outcome Measures

Name	Time	Method
Implant Survival rate (%)	1-3-5 year	Number of implants in situ over the number of placed implants
Aesthetic outcomes	1-3-5 year	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)
PROMs	1-3-5 year	OHIP - 49 Scale (Score 1-3) (Score 1: best outcome; 3 : worst outcome)

Trial Locations

Locations (1)

University Hospital Copenhagen; 🇩🇰 Copenhagen, Denmark