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

Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible (Controlled Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Dental Implant
• Intervention / Treatment: Other: Pre coated impants; Other: Non coated implant surface

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre coated surface implants	Other: 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.
Active Comparator: Non coated surface implants	Other: Non coated implant surface; Non-coated implant with double threading for higher bone-to-implant contact and faster bone gathering on the surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in implant stability	implant stability will be assessed using Osstell device	up to 4 months
change in pain intensity	pain was assessed using visual analogue scale that ranges from 0 (No pain) to 10 (untolerated pain)	1st,3rd, and 7th days
Wound Healing score	Landry healing index was used; Very poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue:Present, Incision margin: Not epithelialized, with loss ofepithelium beyond incision margin, Suppuration: Present; Poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue: Present, Incision margin: Not epithelialized, with connective tissue exposed; Good Tissue colour: ≥25% and<50% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed; Very good Tissue colour: <25% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed; Excellent Tissue color: All tissues pink, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue expose	1st,3rd, and 7th days,14th day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative complications	Occurence of infection was assessed	6 months
Change in bone density	CBCT was used to measure bone density	up to 4 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2022
• Primary Completion (Actual): February 12, 2024
• Study Completion (Actual): February 12, 2024

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 0375-01/2020

Drug and device information, study documents

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