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

NCT ID: NCT05558800

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-07-30

Brief Summary

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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

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Conditions

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Implant Geometry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Xpeed

Implant with Xpeed surface

Group Type ACTIVE_COMPARATOR

Implant placement

Intervention Type PROCEDURE

Implant placement with different surface types

SLA surface

Implant with SLA surface

Group Type ACTIVE_COMPARATOR

Implant placement

Intervention Type PROCEDURE

Implant placement with different surface types

Machined

Implant with machined surface

Group Type PLACEBO_COMPARATOR

Implant placement

Intervention Type PROCEDURE

Implant placement with different surface types

XPEEDActive

Implant with plasma treatment reactivated XPEED implant surface

Group Type ACTIVE_COMPARATOR

Implant placement

Intervention Type PROCEDURE

Implant placement with different surface types

Interventions

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Implant placement

Implant placement with different surface types

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Christian Makari

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Makary, Phd

Role: PRINCIPAL_INVESTIGATOR

Saint Joseph University - Beirut

Locations

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Saint Joseph University

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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XFMD171

Identifier Type: -

Identifier Source: org_study_id