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

Not Applicable

Completed

• Conditions: Implant Geometry
• Interventions: Procedure: Implant placement

• Registration Number: NCT05558800
• Lead Sponsor: Saint-Joseph University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-25
• Study First Posted: 2022-09-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Xpeed	Implant placement	Implant with Xpeed surface
SLA surface	Implant placement	Implant with SLA surface
XPEEDActive	Implant placement	Implant with plasma treatment reactivated XPEED implant surface
Machined	Implant placement	Implant with machined surface

Primary Outcome Measures

Name	Time	Method
Bone to implant contact	6 weeks healing period after implant placement	Histology technique on specimen retrieved containing mini-implants and bone surrounding it

Trial Locations

Locations (1)

Saint Joseph University; 🇱🇧 Beirut, Lebanon