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

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.

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.

Study Overview

• Status: Completed
• Conditions: Implant Geometry
• Intervention / Treatment: Procedure: Implant placement

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xpeed; Implant with Xpeed surface	Procedure: Implant placement; Implant placement with different surface types
Active Comparator: SLA surface; Implant with SLA surface	Procedure: Implant placement; Implant placement with different surface types
Placebo Comparator: Machined; Implant with machined surface	Procedure: Implant placement; Implant placement with different surface types
Active Comparator: XPEEDActive; Implant with plasma treatment reactivated XPEED implant surface	Procedure: Implant placement; Implant placement with different surface types

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone to implant contact	Histology technique on specimen retrieved containing mini-implants and bone surrounding it	4 weeks healing period after implant placement
Bone to implant contact	Histology technique on specimen retrieved containing mini-implants and bone surrounding it	6 weeks healing period after implant placement

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Principal Investigator: Christian Makary, Phd, Saint Joseph University - Beirut

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 25, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: XFMD171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No