Assessment of Osseointegration Properties of Nano-Hydroxy Apatite Coated Titanium Implant

Assessment of Osseointegration Properties of Nano-Hydroxy Apatite Coated Titanium Implant Versus Sandblasted Large Thread Acid Etched Implants in Posterior Maxilla. A Randomized Clinical Trial

the purpose of this trial is to evaluate the osseointegration properties of nano-hydroxy apatite coated titanium implants in posterior maxilla. 30 patients will be included in this trial divided into two groups, control and intervention. Primary and secondary implant stability will be measured

Study Overview

• Status: Completed
• Conditions: Implant Site Reaction
• Intervention / Treatment: Other: nano-hydroxy apatite coated titanium implants; Other: sandblasted large acid itched coated titanium implant

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Ha Mahmoud Ismail, PhD; Phone Number: +201002838699; Email: mmhamdy@msa.edu.eg

Study Locations

• Egypt
  • Giza, Egypt
    • October University for Modern Sciences and Arts faulty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients with missing at least one maxillary posterior tooth
2. Patients free from any systemic disease
3. Patients who approve to be included in the trial and sign the informed consent
4. Patients with no intra-bony defect.
5. Adults aged 18 years old and above

Exclusion Criteria:

1. Patients who are allergic to titanium
2. Heavy smoker patient
3. Patients receiving chemotherapy or radiotherapy
4. Patients who refused to be included in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nano-hydroxy apatite arm; in this groups patients will receive nano-hydroxy apatite coated titanium implants	Other: nano-hydroxy apatite coated titanium implants; titanium implants with surface treatment of nano-hydroxy apatite
Active Comparator: SLA arm; in this group patients will receive sandblasted large thread acid etched titanium implants	Other: sandblasted large acid itched coated titanium implant; titanium implants with SLA surface treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	implant stability will be measured by radiofrequency analysis	immediately post-operative
Implant stability	implant stability will be measured by radiofrequency analysis	4 weeks post-operative
Implant stability	implant stability will be measured by radiofrequency analysis	6 weeks post-operative
Implant stability	implant stability will be measured by radiofrequency analysis	12 weeks post-operative

Collaborators and Investigators

• Sponsor: October University for Modern Sciences and Arts
• Investigators: Principal Investigator: Mohamed H Mahmoud, PhD, october university for modern science and arts faculty of dentistry

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 5, 2024

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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