- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442604
Implant Stability Changes Using Different Technique in Posterior Maxilla With Early Loading Protocol
Implant Stability Changes Using Densah Burs Versus Magnetic Mallet Technique in Posterior Maxilla With Early Loading Protocol: A Randomized Clinical Trial
60 implants were placed in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with normal bone height beneath the floor of the maxillary sinus. The patients were selected from those attending the outpatient clinic of the Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
60 implants will be randomly and uniformly divided into two equal groups: Group 1: It was consisted of 20 inserted dental implants by Densah burs into healed posterior maxillary alveolar ridge with an early loading pattern.
Group 2: It was consisted of 20 inserted dental implants by Magnetic Mallet technique into healed posterior maxillary alveolar ridge with an early loading pattern.
Group 3: It was consisted of 20 inserted dental implants by Conventional Drilling technique into healed posterior maxillary alveolar ridge with an early loading pattern.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Mansurah, Egypt, 002
- Heba elsheikh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient with missing one or more posterior maxillary teeth.
- Patients in the age group between 18 and 60 years old.
- 10 mm or more vertical bone height is present.
- No gender preface in selection of the patients.
- Good oral hygiene.
- Non-smokers.
- Patients willing to be present during the study follow up intervals.
- Patients free from any systemic diseases.
- 6 mm or more ridge width is present.
- Crown height space of at least 8 mm.
- Patients without any para-functional habits (bruxism and clenching).
Exclusion Criteria:
- Patients with any pathological lesion or root tips at the planned surgical site.
- Patients with systemic diseases that contra-indicate the surgical procedure or affect bone healing process such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
- Patient taking drugs that could affect bone healing process as in immunosuppressive drugs and bisphosphonates.
- Alcoholism.
- Untreated periodontal disease or bad oral hygiene.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Densah burs group
|
20 inserted dental implants by Densah burs into healed posterior maxillary alveolar ridge with an early loading pattern.
|
|
Experimental: Magnetic Mallet group
|
20 inserted dental implants by Magnetic Mallet technique into healed posterior maxillary alveolar ridge with an early loading pattern.
|
|
Experimental: Conventional Drilling group
|
20 inserted dental implants by Conventional Drilling technique into healed posterior maxillary alveolar ridge with an early loading pattern.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant stability
Time Frame: 2 months
|
Implant stability was assessed at the time of implant insertion, 1 month and 2 months after surgery.
The analysis of resonance frequency analysis (RFA) was made using an Osstell Mentor apparatus.
The smart peg was attached to the dental implant.
The RFA value was measured 4 times in 4 directions (every 90°).
The results were expressed as implant stability quotient (ISQ) and averaged for each implant.
The ISQ scale ranges from 0 to 100.
The values less than 60 indicate low implant stability, values from 60 to 69 indicate medium stability, while values from 70 to 79 indicate high stability.
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.26.01.101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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