Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)
Primary Purpose
Alveolar Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Platelet rich fibrin (PRF)
Advanced platelet rich fibrin (A-PRF)
blood clot
Sponsored by
About this trial
This is an interventional prevention trial for Alveolar Bone Resorption
Eligibility Criteria
Inclusion Criteria:
- Patients with at least one non restorable tooth in upper inter-bicuspid region.
- Stable periodontal condition with no acute periapical infection.
- Systematically healthy conditions.
- Cooperative patients.
- Intact buccal plate of bone.
Exclusion Criteria:
- Smokers.
- Patients seeking immediate or early implants.
- Pregnant females.
- Bone diseases.
- Drugs and diseases that may affect platelet count or function.
Sites / Locations
- School of dentistry , Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Platelet rich fibrin (PRF)
Advanced platelet rich fibrin (A-PRF)
blood clot
Arm Description
Platelet rich fibrin is the secoond generation of platelet concentrates which is an autogenous biomaterial that is prepared from the patient's own blood
Advanced platelet rich fibrin is the last modification of PRF which is expected to contain a relatively greater number of white blood cellsand growth factors
normal healing of the wound without adding any biomaterial
Outcomes
Primary Outcome Measures
Change in bucco-lingual dimensions
clinical measurement using bone caliper in mm numerical
Secondary Outcome Measures
change in alveolar bone height
radiographic measurement using CBCT in mm numerical
bone dentistry
radiographic measurement using CBCT
soft tissue healing
clinical measurement using landr et al index (healing index) in numerical
postoperative pain scores
clinical measurement using VAS scale in numerical where No pain (0-4 mm) - mild pain (5-44 mm) -moderate pain (45-74 mm), and severe pain (75- 100 mm).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04434703
Brief Title
Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)
Official Title
Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF) A Randomized Clinical Trail :Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the aim of this study is clinically and radiographically evaluate the use of advance platelet rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge following tooth extraction
Detailed Description
systemically healthy patients who have at least one non-restorable tooth in the upper inter-bicuspid region and are not seeking immediate or early implant treatment will be allocated in this study after performing nonsurgical periodontal therapy and preoperative periapical therapy to evaluate and improve the condition of the periodontal tissues.
Anesthesia will be given then flapless atraumatic extraction using periotomes followed by forceps after luxation. For all groups, the socket will be debrided using curette then
group A, the socket will be filled with A.PRF
group B the socket will be filled with PRF.
group C no bio-additive will be added.
Criss cross horizontal mattress suture will be applied to close the extraction wound.
PRF and A-PRF preparation :
10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein.
Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant
Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich fibrin (PRF)
Arm Type
Active Comparator
Arm Description
Platelet rich fibrin is the secoond generation of platelet concentrates which is an autogenous biomaterial that is prepared from the patient's own blood
Arm Title
Advanced platelet rich fibrin (A-PRF)
Arm Type
Experimental
Arm Description
Advanced platelet rich fibrin is the last modification of PRF which is expected to contain a relatively greater number of white blood cellsand growth factors
Arm Title
blood clot
Arm Type
Placebo Comparator
Arm Description
normal healing of the wound without adding any biomaterial
Intervention Type
Procedure
Intervention Name(s)
Platelet rich fibrin (PRF)
Intervention Description
following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 3000 rpm for 10 minutes then criss horizontal mattress suture will be applied to close the extraction wound
Intervention Type
Procedure
Intervention Name(s)
Advanced platelet rich fibrin (A-PRF)
Intervention Description
following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 1300 rpm for 8 minutes then criss horizontal mattress suture will be applied to close the extraction wound
Intervention Type
Procedure
Intervention Name(s)
blood clot
Intervention Description
following atraumatic extraction of the tooth using periotomes, no bio-addative will be added and criss horizontal mattress suture will be applied to close the extraction wound
Primary Outcome Measure Information:
Title
Change in bucco-lingual dimensions
Description
clinical measurement using bone caliper in mm numerical
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in alveolar bone height
Description
radiographic measurement using CBCT in mm numerical
Time Frame
6 months
Title
bone dentistry
Description
radiographic measurement using CBCT
Time Frame
6 months
Title
soft tissue healing
Description
clinical measurement using landr et al index (healing index) in numerical
Time Frame
6 months
Title
postoperative pain scores
Description
clinical measurement using VAS scale in numerical where No pain (0-4 mm) - mild pain (5-44 mm) -moderate pain (45-74 mm), and severe pain (75- 100 mm).
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with at least one non restorable tooth in upper inter-bicuspid region.
Stable periodontal condition with no acute periapical infection.
Systematically healthy conditions.
Cooperative patients.
Intact buccal plate of bone.
Exclusion Criteria:
Smokers.
Patients seeking immediate or early implants.
Pregnant females.
Bone diseases.
Drugs and diseases that may affect platelet count or function.
Facility Information:
Facility Name
School of dentistry , Cairo University
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
it will include participant's contacts ( name, age , phone number , address ,medical and dental history , periodontal condition) ,periodontal chart and preoperative radiograph
Learn more about this trial
Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)
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