- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07304986
Efficacy of i-PRF Usage in Vestibular Socket Therapy
A Novel Method for Evaluating i-PRF Usage in Vestibular Socket Therapy for Immediate Implant in Defective Fresh Extraction Site
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The ultimate objective of implant treatment is providing long-lasting, healthy hard and soft tissue architecture while minimizing intraoperative surgical trauma and postoperative complications. Reducing treatment duration and providing a predictable esthetic outcome are fundamental. Immediate implant placement in fresh extraction sockets is an appealing treatment option satisfying many of these requirements. However, a major concern with immediate implant placement is the possible resorption of the facial bone plate as indicated in multiple studies. This, in turn, results in loss of proper soft tissue support, thus compromising the final esthetic outcome of the implant- supported restoration. Furthermore, post extraction bone resorption would be compounded by the presence of a thin or preexisting facial bone defect and/or a thin gingival phenotype. Multiple approaches were suggested to prevent facial bone resorption and optimize the final esthetic outcome after immediate implant placement in sockets with intact facial bone and soft tissue. These approaches include simple ones like applying a graft in the gap between the implant and the facial socket wall and more sophisticated approaches such as the socket shield technique . The presence of bone and/or soft tissue defects after tooth extraction is not an uncommon finding, further complicating immediate implant placement. Several classifications for fresh extraction sockets were proposed to facilitate the selection of optimum treatment for individual cases.
Currently, a serious of studies has shown that iPRF can produce significantly greater concentrations of platelets and leukocytes when compared to the L-PRF and A-PRF.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nasr City
-
Cairo, Nasr City, Egypt, 11371
- AlAzharU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients has one hopeless tooth in the maxillary anterior region with TYPE II according to Elian classification of sockets (10) and sufficient bone apically and palatally.
- The presence of a natural contralateral tooth for the tooth being replaced.
Exclusion Criteria:
- Extraction sockets were grade III.
- Acute infection related to hopeless tooth.
- Allergy to any material or medication used in the study.
- Medically compromised patients according to modified Cornell Medical Index.
- Heavy smokers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: deficient facial plate of bone management VST only
Sockets with deficient facial plate of bone and intact soft tissue will receive VST only.
|
Preoperative procedure: cone beam computed tomography (CBCT) scan will be used for diagnosis and treatment planning.
Nonsurgical periodontal treatment including scaling and root planning will be performed as needed.
Under local anesthesia sulcular incisions will be made, and then hopeless teeth will be extracted atraumatically using periotomes.
Socket lavage and curettage will be done thoroughly, and dental implants will be inserted.
|
|
Active Comparator: deficient facial plate of bone management with VST and iPRF.
Sockets with deficient facial plate of bone and intact soft tissue will receive VST and iPRF.
|
Preoperative procedure: cone beam computed tomography (CBCT) scan will be used for diagnosis and treatment planning.
Nonsurgical periodontal treatment including scaling and root planning will be performed as needed.
Under local anesthesia sulcular incisions will be made, and then hopeless teeth will be extracted atraumatically using periotomes.
Socket lavage and curettage will be done thoroughly, and dental implants will be inserted with i-prf.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of pink aesthetic score of the gingiva
Time Frame: 6 and 9 months.
|
Assessment of clinical and aesthetic parameters after the newly proposed immediate implant placement technique. using pik aesthetic score of gingiva, The Pink Esthetic Score (PES) is a dental assessment tool scoring gingival aesthetics around implants, evaluating mesial/distal papillae, tissue level/contour/color/texture, and alveolar deficiency. Scoring System 0 (Poor): Marked deficiency or abnormality.
|
6 and 9 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facial bone thickness
Time Frame: base line, 6 and 9 months.
|
Assessment of radiographic parameters after the newly proposed immediate implant placement technique.will
be assessed from implant surface to outer surface of bone will be recorded using cone beam CT, at base line, 6 and 9 months.
and will be recorded in millimeters.
|
base line, 6 and 9 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: abdullah el-shamy, MSC, Al-Azhar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 921/1704
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Esthetic Zone
-
Hams Hamed AbdelrahmanNot yet recruitingMaxillary Esthetic Zone | Socket Shield TechniqueLebanon
-
Cairo UniversityUnknownImplant Placement in Maxillary Esthetic ZoneEgypt
-
Cairo UniversityUnknownHybrid Crowns on Single Implants in Esthetic ZoneEgypt
-
Hams Hamed AbdelrahmanNot yet recruitingTooth Extraction | Immediate Dental Implant | Photocoagulation | Maxillary Esthetic ZoneLebanon
-
Cairo UniversityNot yet recruitingImplant Placement in Maxillary Esthetic Zone | Immediate Dental Implant LoadingEgypt
-
October 6 UniversityCompletedPlatelet Rich Fibrin | Esthetic Zone | Symphysis Onlay Bone Graft | Xenograft | Horizontal Alveolar Ridge AugmentationEgypt
-
Cairo UniversityCompletedImmediate Dental Implants Connective Tissue Graft Esthetic ZoneEgypt
-
Tanta UniversityCompletedThin Labial Plate of Bone Pre-extraction | Immediate Dental Implants | Hopeless Tooth in Esthetic ZoneEgypt
-
Mohammed Mashhout Eisa AnasActive, not recruitingAlveolar Ridge Augmentation, Dental Implants | Alveolar Ridge Deficiency in the Anterior Esthetic ZoneEgypt
-
Cairo UniversityRecruitingEsthetic Zone | Immediate Implant Placement | Anterior Maxilla | Safe Angle PositionEgypt
Clinical Trials on Immediate implant with VST
-
Mohamed Adel AlfekyRecruitingVestibular Socket Therapy | Immediate Dental Implant in Type 2 Extraction SocketEgypt
-
Cairo UniversityBioHorizons, Inc.CompletedImplant Site InfectionEgypt
-
Cairo UniversityCompleted
-
Cairo UniversityBioHorizons, Inc.Completed
-
Mansoura UniversityCompleted
-
Dalia Rasheed IssaCompletedImmediate Implant Placement | Autogenous Tooth Bone Graft | L-PRFEgypt
-
Università Vita-Salute San RaffaeleCompleted
-
Basma Gamal Mohamed AhmedRecruitingAlveolar Bone Loss | Tooth Extraction Status Nos | Immediate Implant PlacementEgypt
-
Mansoura UniversityEnrolling by invitation
-
Krishnadevaraya College of Dental Sciences & HospitalNot yet recruiting