Assessment of Rapid Osseointegration of Dental Implants with Different Coatings

October 18, 2024 updated by: Mohamed Hamdy Mahmoud Ismail, October University for Modern Sciences and Arts

Assessment of Osseointegration of Dental Implants with Three Different Coatings for Early Loading Purpose and Marginal Bone Loss in the Posterior Maxilla. a Randomized Clinical Trial

The study will assess early osseointegration of dental implant with three different coating materials through secondary implant stability

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dental implants with sandblasted acid itched coating, nano-hydroxyapatite coating, and hyalouronic acid coating will be placed in the posterior maxilla to restore a missing tooth. Implant stability by the use of Ostell will be measured immediately post-operative, 4, 6, and 12 weeks post-operative.

marginal bone loss around the implants will be compared immediately after final restoration delivery and after one year

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Faculty of Dentistry, MSA University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sandblasted acid etched group
sandblasted acid etched coated implants will be allocated to this arm
Other: sandblasted acid etched
SLA coated implants will be placed in posterior maxilla and implant stability will be evaluated
Active Comparator: nano-hydroxyapatite group
nano-hydroxyapatite coated implants will be allocated to this arm
Other: nano-hydroxyapatite
nano-hydroxyapatite coated implants will be placed in posterior maxilla to assess rapid osseointegration
Experimental: hyaluronic acid group
hyaluronic acid coated implants will be allocated to this arm
Other: Hyaluronic Acid (HA)
hyaluronic acid coated implants will be placed in posterior maxilla to evaluate rapid osseointegration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rapid osseintegration
Time Frame: immediately post-operative, 4, 6, and 12 weeks post-operative
rapid osteointegration of dental implants will be evaluated by the use of Ostell device which measures primary and secondary stability expressed as ISQ measures ranging from zero till 90
immediately post-operative, 4, 6, and 12 weeks post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
marginal bone loss
Time Frame: immediately after final restoration delivery and one year post-operative
the bone height from implant's platform till implant's tip will be measured and compared between immediately after final restoration delivery and after one year
immediately after final restoration delivery and one year post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October University for Modern Sciences and Arts

Investigators

  • Principal Investigator: Mohamed Hamdy, Lecturer, Faculty of Dentistry, MSA University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31910-4

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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