Early Loading for Implants With Calcium Titanate Surface Technology in Posterior Mandibular Bone
Feasibility of Early Loading for Implants With Calcium Titanate Surface Technology in Posterior Mandibular Bone
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Azarita
-
Alexandria, Azarita, Egypt, 00203
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adequate bone volume allowing implant placement without grafting (width > 6 mm, height > 10 mm)
- bone quality classified as D2
Exclusion Criteria:
- uncontrolled systemic diseases
- active infection or untreated periodontal disease
- heavy smoking (>10 cigarettes/day)
- parafunctional habits
- inability to attend follow-up visits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Conventional
|
Conventional Delayed Loading at 24 weeks, the definitive restoration was delivered using standard prosthetic procedures.
|
|
Experimental: Test Group
|
Early Loading at 4 weeks, a screw-retained definitive restoration was delivered using standard prosthetic procedures.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in implant stability
Time Frame: baseline, 2 ,4 ,12 ,24 weeks
|
Ostell device was used for implant stability assessment.
|
baseline, 2 ,4 ,12 ,24 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in bone gain
Time Frame: 12 and 24-weeks
|
amount of marginal bone resorption measured mesially and distally from the implant-abutment junction to the first bone-to-implant contact using digital image analysis software
|
12 and 24-weeks
|
|
Change in density
Time Frame: 12 and 24-weeks
|
CBCT is used for bone density assessmnet
|
12 and 24-weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1043_03/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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