- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04224935
Comparing the Position of Collagen Membrane During Immediate Implant Placement
Compraing the Effect of Placement of Collagen Membrane Inside the Extraction Socket and Outside it During Immediate Implant Placement
Study Overview
Status
Intervention / Treatment
Detailed Description
Twenty patients, who are candidates for immediate implant placement, will participate in this prospective clinical trial.
Group 1(10 patients) :
immediate implant placement with bone graft and collagen memebrane outside the buccal plate
Group 2 (Control group)(10 patients) :
immediate implant placement with bone graft and collagen memebrane inside the buccal plate assessment of the buccal bone thickness assessment of soft tissue thickness
• Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include
Both evaluations will be done at 3, 6 and 9 months
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt
- Faculty Of Dentistry Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Systemically free patients (American Society of Anesthesiologists I; ASA I).
- Age range (20 -50) years.
- Good compliance with the plaque control instructions following initial therapy.
- Patients diagnosed badly decayed tooth in esthetic zone indicated for immediate implant placement
- Availability for follow up and maintenance program.
Exclusion Criteria:
- Patient suffering from periodontitis
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant and lactating females.
- Vulnerable group of patients (handicapped, mentally retarded and prisoners).
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 |
|---|---|
|
Active Comparator: collagen membrane inside
during immediate implant placement collagen membrane will be placed into the jumping gap
|
during immediate implant placement the collagen membrane will be placed in the jumping gap
|
|
Active Comparator: collagen membrane outside
during immedoate implant placement collagen membrane will be placed on the outersurface of the buccal plate of bone
|
during immediate implant placement the collagen membarne will be placed on the surface of the buccal plate of bone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
buccal plate of bone thickness
Time Frame: baseline 12 months
|
assessment of the buccal plate of bone will be determined in mm from CBCT
|
baseline 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
soft tissue thickness (Volumetric assessment)
Time Frame: baseline, 6 and 12 months
|
Preoperative scanning will be done.
At 6,12 months after surgical procedure the same procedure will be done to determine the soft tissue thickness after the surgery.
The difference between the tissue thickness before and after
|
baseline, 6 and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mai Shafik, professor, Misr international univeristy
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 453
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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