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Active, Not Recruiting

NCT Number: NCT04006782

Narrow Dental Implants in Multiple Fixed Prosthesis: A Controlled Clinical Trial

The objective of this study is to evaluate the survival of narrow dental implants (≤ 3,5 mm) in multiple fixed prostheses in comparison with standard diameter dental implants (≥ 3,75 mm) after 5 years of follow-up. The hypothesis of the study is that narrow dental implants under the evaluated conditions, have the same survival rate and clinical performance than the standard diameter implants.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Edentulous Alveolar Ridge Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Dental Eduardo Anitua

Vitoria-Gasteiz, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients of legal age (>18 years) of both sexes.
  • Clinical need of multiple fixed alveolar ridge rehabilitations.
  • Clinical suitability to insert, at least, one narrow dental implant splinted to a standard diameter dental implant.
  • Signature of the informed consent

Exclusion criteria

  • Presence of an active infection
  • Being under active treatment with, or have received in the las 30 days treatment with radiotherapy, chemotherapy, immunosuppressors, systemic corticosteroids and/or anticoagulants.
  • Presence of severe haematologic disorders.
  • Chronic treatment with non steroidal anti-inflammatory drugs (NSAID) or other aniinflammatory drugs.
  • Previous diagnosis of chronic hepatitis or liver cirrhosis.
  • Presence of Diabetes mellitus with improper metabolic control (glycosylated haemoglobine higher that 9%).
  • Patients subjected to dialysis.
  • Presence of malignant tumours, haemangioma or angioma in the surgical area.
  • History of ischaemic cardiopathy in the las year.
  • Pregnancy or plan to getting pregnant during the study.
  • Metabolic bone disease
  • Patientd receiving treatment with oral or intravenous biphosphonates.
  • Any other condition incompatible with the participation in the study,

Treatment and study plan

Narrow dental implants

Device

Insertion of narrow dental implants in multiple fixed prosthesis

Primary outcomes

  1. Survival after 5 years of follow-up

    Time frame: 5 years in comparison with the baseline

    Implant survival after 5 years of follow-up

Secondary outcomes

  1. Marginal Bone Loss

    Time frame: 1, 3 and 5 years in comparison with the baseline

    Evolution of the peri-implant bone level along the study follow up

Sponsors and collaborators

Lead sponsor

Fundación Eduardo Anitua

Other

Registry information

Official study title

Narrow Dental Implants in Multiple Fixed Prosthesis

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2019
Registry last updated
Feb 27, 2025

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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