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Completed

NCT Number: NCT06528327

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

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.

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Key information

Conditions

Dental Implant Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre coated impants

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 implant surface

Other

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

Primary outcomes

  1. change in implant stability

    Time frame: up to 4 months

    implant stability will be assessed using Osstell device

  2. change in pain intensity

    Time frame: 1st,3rd, and 7th days

    pain was assessed using visual analogue scale that ranges from 0 (No pain) to 10 (untolerated pain)

  3. Wound Healing score

    Time frame: 1st,3rd, and 7th days,14th day

    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

Secondary outcomes

  1. Post operative complications

    Time frame: 6 months

    Occurence of infection was assessed

  2. Change in bone density

    Time frame: up to 4 months

    CBCT was used to measure bone density

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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