- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07495488
Comparison Between Two Placement Concepts of Six Compressive
March 21, 2026 updated by: Samah samir mohamed Ahmed Darwish, Mansoura University
Comparison Between Two Placement Concepts of Six Compressive Implants in the Maxillary Edentulous Ridge and Immediately Loaded With a Full Arch Prosthesis: A Study of Implant Stability and Peri-implant Tissue Health
The aim of this study will be to compare two posterior implant positioning concepts of six compressive implants installed in completely edentulous maxilla and immediately loaded with screw retained prosthesis regarding implant stability and peri-implant tissue health (plaque index ,bleeding index and pocket depth )
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
-
Al Mansurah, Egypt, P.O.Box:35516
- Faculty of Dentistry
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy Patients with completely edentulous maxilla opposing a dentate mandible or a mandible restored with a full arch fixed prosthesis will be selected for this study from the outpatient clinic, Prosthodontic Department, Faculty of Dentistry, Mansoura University.
Exclusion Criteria:
- patients not be a diabetic or smoker
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 |
|---|---|
|
Active Comparator: Group I: PARALLEL
Group I: Six compressive implants will be installed parallel to each other in the canine and 2nd premolar areas
|
six implants will be placed in the maxilla in the following area ( canine , premolar , molar )
|
|
Active Comparator: Group 2: inclined
Group II: Six compressive implants will be installed with two posterior inclined implants.
|
six implants will be placed in the maxilla in the following area ( canine , premolar , molar )
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
implant stability
Time Frame: 6 months
|
Implant stability will be measured by ISQ using an Ostell device
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
plaque index
Time Frame: one year
|
plaque index will be measured with periodontal probe according to the following score 0; absence plaque , score 1; plaque only detected by a probe passing through the smooth marginal surface of the implant, score 2; plaque can be recognized by naked eye, and score 3; plenty of soft matter.
|
one year
|
|
gingival index
Time Frame: one year
|
gingival index and bleeding will be measured using periodontal probe according to the following score ; 0; no bleeding when a periodontal probe is passed along the mucosal margin, 1;isolated bleeding spots visible, 2; blood forms a confluent red line on the mucosal margin, 3;heavy or profuse bleeding
|
one year
|
|
Pocket Depth
Time Frame: one year
|
Pocket Depth around implant will be measured by mm using periodontal probe
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 2, 2024
Primary Completion (Actual)
March 25, 2025
Study Completion (Actual)
March 10, 2026
Study Registration Dates
First Submitted
May 3, 2025
First Submitted That Met QC Criteria
March 21, 2026
First Posted (Actual)
March 27, 2026
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 21, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M02010024RP
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
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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