- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07588789
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group (Implants types)
Basal Versus Compressive Implant Designs Immediately Loaded With Bar Retained Complete Overdenture for Atrophied Edentulous Mandibular Ridge: Clinical and Radiographic Study of peri_implant Tissue Health
The aim of the present study will be clinical and radio graphical comparison of four basal and compressive implant designs will be installed in the interforamina area of atrophied edentulous mandible and immediately loaded by screw retained mandibular overdenture .
Implant design comparison will be done clinically and radiographically after one and two years of implant loading
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be divided randomly in to 2 equal groups:
- Group1: this group will receive immediate loaded screw retained complete overdenture supported by 4 basal implants design .
- Group2 :this group will receive immediate loaded screw retained complete overdenture supported by 4 compressive implants design
- After final implant placements, they will be immediately scanned by intraoral scanner to construct milled in titanium bar which will be immediately screwed into the implants
- Mandibular screw retained complete overdenture will be constructed.
Evaluation will be for:
- Peri implant tissue health that will be measured according to mombelli(12) at the time of insertion(T0), 6months(T1) and 12months (T2).
- Marginal bone height changes will be measured using standardized digital panoramic x-ray(13) after 6months (T0), 12month(T1) and 24months(T2) after prosthesis insertion.
- Periotest will evaluate the stability of the implants during implantation (T0) , 3months(T1) and 6months(T3) following surgery(14) .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Mansurah, Egypt
- Faculty of Dentistry Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-
mandibular and maxillary alveolar ridges are completely edentulous (2) There is not sufficient bone in the mandibular posterior molar area to place implants and there is a thin ridge anteriorly (3) skeletal class I maxilla-mandibular relationship (4) Devoid o f any systemic disorders related to bone resorptio
Exclusion Criteria:
- present of systematic disease Chem therapy Bone diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Basal implant Group
Patients in this group will receive four basal implants placed in the atrophied edentulous mandible.
Implants will be immediately loaded using a bar-retained mandibular overdenture.
Clinical and radiographic evaluations will be performed to assess implant stability and peri-implant tissue health over the follow-up period.for
3,6,12months intervventions
|
Placement of four basal dental implants in the atrophied edentulous mandible followed by immediate loading using a bar-retained mandibular overdenture.
Other Names:
|
|
Experimental: Compressive Dental implant
Patients in this group will receive four compressive implants placed in the atrophied edentulous mandible.
Implants will be immediately loaded using a bar-retained mandibular overdenture.
Clinical and radiographic evaluations will be performed to assess implant stability and peri-implant tissue health over the follow-up period.
|
Placement of four compressive dental implants in the atrophied edentulous mandible followed by immediate loading using a bar-retained mandibular overdenture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peri-implant tissue health
Time Frame: Baseline, 6 months, and 12 months after implant loading.
|
Peri-implant tissue health that will be measured according to mombelli for both groups
|
Baseline, 6 months, and 12 months after implant loading.
|
|
Marginal bone height changes
Time Frame: Baseline, 6 months, and 12 months after implant loading.
|
Marginal bone height changes will be measured using standardized digital panoramic x-ray for both groups
|
Baseline, 6 months, and 12 months after implant loading.
|
|
Implant stability
Time Frame: Baseline, 6 months, and 6 months after implant loading.
|
Periotest will evaluate the stability of the implants during implantation for both groups
|
Baseline, 6 months, and 6 months after implant loading.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gilan Altonbary, Ass.prof, Mansoura University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDP.25.06.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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