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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06528327
Enrollment
10
Registered
2024-07-30
Start date
2022-06-26
Completion date
2024-02-12
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant, Diabetes Mellitus, Type 2

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.

Interventions

OTHERPre 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.

OTHERNon coated implant surface

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

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Split Mouth Design

Eligibility

Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
change in implant stabilityup to 4 monthsimplant stability will be assessed using Osstell device
change in pain intensity1st,3rd, and 7th dayspain was assessed using visual analogue scale that ranges from 0 (No pain) to 10 (untolerated pain)
Wound Healing score1st,3rd, and 7th days,14th dayLandry 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

Secondary

MeasureTime frameDescription
Post operative complications6 monthsOccurence of infection was assessed
Change in bone densityup to 4 monthsCBCT was used to measure bone density

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026