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

NCT05558800 | Completed

• 1 other identifier: XFMD171
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant Geometry

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Xpeed

ACTIVE COMPARATOR

Implant with Xpeed surface

Procedure: Implant placement

SLA surface

ACTIVE COMPARATOR

Implant with SLA surface

Procedure: Implant placement

Machined

PLACEBO COMPARATOR

Implant with machined surface

Procedure: Implant placement

XPEEDActive

ACTIVE COMPARATOR

Implant with plasma treatment reactivated XPEED implant surface

Procedure: Implant placement

Interventions

Implant placement PROCEDURE

Implant placement with different surface types

Machined; SLA surface; XPEEDActive; Xpeed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

Study Officials

• Christian Makary, Phd

  Saint Joseph University - Beirut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 28, 2022
• Study Start: January 1, 2018
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

LE (1)