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OpenTrials
Completed

NCT Number: NCT05558800

Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants With Different Surfaces.

Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. The main objective of the present clinical study is to compare, at 4 and 6w, bone-to-implant contact in implants having either machined surface (MAC), SLA medium roughness surface or a Nanostructured Calcium-Incorporated surface (XPEED®). Thirty five mini-implants with 3 different surface treatments (XPEED® (n=16) - SLA (n=13) - Machined (n=6)), were placed in the posterior maxilla of 11 patients then retrieved at either 4 or 6w in a randomized split-mouth study design.

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Key information

Conditions

Implant Geometry

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph University

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • • Height of the residual bone crest in the programmed implant site ≥ 9 mm and thickness ≥ 7mm.
  • Availability, in each sector, of sufficient mesio-distal space allowing placement of 2 standard-sized implants and at least 2 mini-implants (3.5x8.5mm) for retrieval.
  • Healed bone crest (≥ 3 months elapsed after extraction or tooth loss).
  • Age > 18 years.
  • Ability to examine and fully understand the study protocol.

Exclusion criteria

  • • Myocardial infarction within the past 6 months.
  • Poorly controlled diabetes (HBA1c > 7.5%).
  • Coagulation disorders.
  • Radiotherapy to the head/neck area within the past two years.
  • Present or past treatment with intravenous bisphosphonates.
  • Immunocompromised patients.
  • Psychological or psychiatric problems.
  • Alcohol or drug abuse.
  • Poor oral hygiene and motivation (full mouth plaque score > 30% and/or full mouth bleeding score > 20%).
  • Uncontrolled periodontal disease.

Treatment and study plan

implant placement

Procedure

Implant placement with different surface types

Primary outcomes

  1. Bone to implant contact

    Time frame: 4 weeks healing period after implant placement

    Histology technique on specimen retrieved containing mini-implants and bone surrounding it

  2. Bone to implant contact

    Time frame: 6 weeks healing period after implant placement

    Histology technique on specimen retrieved containing mini-implants and bone surrounding it

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants Having Either Machined, SLA Medium Roughness, Nanostructured Calcium-Incorporated or Plasma Reactivated Nanostructured Calcium-Incorporated Surface: A Histologic Study.

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 28, 2022
Registry last updated
Nov 30, 2023

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.