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OpenTrials
Completed

NCT Number: NCT06500923

Narrow-diameter Implants Replacing 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).

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Key information

Conditions

Dental Implant Failed

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Copenhagen

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral rehabilitation by means of implant-supported single unit crowns

Other

Surgery: Implant placement; Prothetic rehabilitation: single unit crown

Primary outcomes

  1. Peri-implant marginal bone level changes

    Time frame: 1 year

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

Secondary outcomes

  1. Implant Survival rate (%)

    Time frame: 1-3-5 year

    Number of implants in situ over the number of placed implants

  2. Aesthetic outcomes

    Time frame: 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)

  3. PROMs

    Time frame: 1-3-5 year

    OHIP - 49 Scale (Score 1-3) (Score 1: best outcome; 3 : worst outcome)

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • Copenhagen University Hospital, Denmark

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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