Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible

NCT ID: NCT06528327

Last Updated: 2024-07-30

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-26

Study Completion Date

2024-02-12

Brief Summary

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Dental implant's surface properties significantly influence both biological and mechanical integration. Surface bio-treatment could accelerate and enhance bone regeneration, ensuring successful implantation. therefore, this study compares bone densification, primary and secondary stability, wound healing, and pain intensity between pre-coated antimicrobial surfaces of dental implants versus non-coated surfaces in controlled type 2 diabetic patients.

Detailed Description

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Conditions

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Dental Implant Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Split Mouth Design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre coated surface implants

Group Type EXPERIMENTAL

Pre coated impants

Intervention Type OTHER

Pre coated impants with microstructured bioactive antimicrobial coating with double threading for higher bone-to-implant contact and faster bone gathering on the surface.

Non coated surface implants

Group Type ACTIVE_COMPARATOR

Non coated implant surface

Intervention Type OTHER

Non-coated implant with double threading for higher bone-to-implant contact and faster bone gathering on the surface.

Interventions

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Pre coated impants

Pre coated impants with microstructured bioactive antimicrobial coating with double threading for higher bone-to-implant contact and faster bone gathering on the surface.

Intervention Type OTHER

Non coated implant surface

Non-coated implant with double threading for higher bone-to-implant contact and faster bone gathering on the surface.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adequate interproximal space.
* Adequate interocclusal space.
* Adequate anatomical location, accessibility, and visualization for easy surgical implant placement.
* Both genders.
* Controlled medical condition

Exclusion Criteria

* Presence of parafunctional dependency as bruxism.
* Adjacent pathosis near the implant site.
* Patient under radiotherapy targeting the head and neck.
* Heavy smokers.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant Lecturer of Dental Public Health and biostatistical consultanat

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0375-01/2020

Identifier Type: -

Identifier Source: org_study_id

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