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

Not Applicable

Completed

• Conditions: Dental Implant; Diabetes Mellitus, Type 2
• Interventions: Other: Non coated implant surface; Other: Pre coated impants

• Registration Number: NCT06528327
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-26
• Primary Completion: 2024-02-12
• Study Completion: 2024-02-12
• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non coated surface implants	Non coated implant surface	-
Pre coated surface implants	Pre coated impants	-

Primary Outcome Measures

Name	Time	Method
change in pain intensity	1st,3rd, and 7th days	pain was assessed using visual analogue scale that ranges from 0 (No pain) to 10 (untolerated pain)
Wound Healing score	1st,3rd, and 7th days,14th day	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
change in implant stability	up to 4 months	implant stability will be assessed using Osstell device

Secondary Outcome Measures

Name	Time	Method
Post operative complications	6 months	Occurence of infection was assessed
Change in bone density	up to 4 months	CBCT was used to measure bone density

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt