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

NCT06528327 | Completed

• 1 other identifier: 0375-01/2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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; 1. 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 2. Poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue: Present, Incision margin: Not epithelialized, with connective tissue exposed 3. Good Tissue colour: ≥25% and\<50% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed 4. Very good Tissue colour: \<25% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed 5. 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 Outcomes (2)

• Post operative complications

  6 months

• Change in bone density

  up to 4 months

Study Arms (2)

Pre coated surface implants

EXPERIMENTAL

Other: Pre coated impants

Non coated surface implants

ACTIVE COMPARATOR

Other: Non coated implant surface

Interventions

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.

Pre coated surface implants

Non coated implant surface OTHER

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

Non coated surface implants

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health and biostatistical consultanat

Model Details: Split Mouth Design

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 30, 2024
• Study Start: June 26, 2022
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (1)