Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin
Primary Purpose
Ridge Preservation, Alveolar Bone Loss, Dentin Graft
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
injectable platelet rich fibrin with demineralized dentin graft
demineralized dentin graft
Sponsored by
About this trial
This is an interventional treatment trial for Ridge Preservation
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years need of at least one single rooted tooth extraction.
- Non-restorable teeth.
- Systemically healthy patients.
- Good oral hygiene, Plaque index less than 15%.
- Non-smoker or Smoking ≤ 10 cigarettes/day.
- Cooperative patients able and accept to come for follow up appointments.
Exclusion Criteria:
- Any interim intervention that may have affected any of the outcomes of interest.
- Pregnant and lactation females.
- Smoking ˃ 10 cigarettes/day.
- Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
- Patients with poor oral hygiene.
- Any known allergies.
Sites / Locations
- Faculty of Dentistry, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
injectable platelet rich fibrin with deminerlized dentin graft
deminerlized dentin graft
Arm Description
injectable platelet rich fibrin with deminerlized dentin graft for ridge preservation after teeth extraction
deminerlized dentin graft for ridge preservation after teeth extraction
Outcomes
Primary Outcome Measures
Radiographic Bucco-lingual ridge width change
radiographic measurement
Secondary Outcome Measures
Changes in the height of the socket buccal and lingual ridges.
radiographic measurement
postoperative pain
Visual analogue scale from zero (better) to 10 (worse)
Patient satisfaction
binary yes and no
Keratinized tissue width
periodontal probe measurement
chair time
in minutes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05437172
Brief Title
Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin
Official Title
Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin (A Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
December 15, 2023 (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
5. Study Description
Brief Summary
Ridge preservation should be considered whenever possible after tooth extraction. Whether implant placement would be performed or for aesthetic consideration at pontic sites when conventional bridge is planned. Ridge preservation aims to maximize the bone formation accompanied with good soft tissue architecture to facilitate implant and prosthetic replacement restoring function, phonetics and aesthetics. the Aim of the study is To evaluate the bucco-lingual ridge width clinically and radiographically, height of buccal and lingual ridges of the socket after application of injectable platelet rich fibrin and autogenous dentin graft.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ridge Preservation, Alveolar Bone Loss, Dentin Graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
injectable platelet rich fibrin with deminerlized dentin graft
Arm Type
Experimental
Arm Description
injectable platelet rich fibrin with deminerlized dentin graft for ridge preservation after teeth extraction
Arm Title
deminerlized dentin graft
Arm Type
Active Comparator
Arm Description
deminerlized dentin graft for ridge preservation after teeth extraction
Intervention Type
Procedure
Intervention Name(s)
injectable platelet rich fibrin with demineralized dentin graft
Intervention Description
after atraumatic extraction, collection of whole venous blood (9 ml) in sterile vacutainer tubes will be done without anticoagulant added, vacutainer tubes will be then placed in a centrifugal machine at 700 revolutions per minute (rpm) for 3 min with a tube filled with water to maintain the balance during the centrifuging process. ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.
Intervention Type
Procedure
Intervention Name(s)
demineralized dentin graft
Intervention Description
after atraumatic extraction, ADDG particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze.
Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.
Primary Outcome Measure Information:
Title
Radiographic Bucco-lingual ridge width change
Description
radiographic measurement
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Changes in the height of the socket buccal and lingual ridges.
Description
radiographic measurement
Time Frame
up to 24 weeks
Title
postoperative pain
Description
Visual analogue scale from zero (better) to 10 (worse)
Time Frame
immediately after the procedure
Title
Patient satisfaction
Description
binary yes and no
Time Frame
immediately after the procedure
Title
Keratinized tissue width
Description
periodontal probe measurement
Time Frame
up to 24 weeks
Title
chair time
Description
in minutes
Time Frame
immediately after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years need of at least one single rooted tooth extraction.
Non-restorable teeth.
Systemically healthy patients.
Good oral hygiene, Plaque index less than 15%.
Non-smoker or Smoking ≤ 10 cigarettes/day.
Cooperative patients able and accept to come for follow up appointments.
Exclusion Criteria:
Any interim intervention that may have affected any of the outcomes of interest.
Pregnant and lactation females.
Smoking ˃ 10 cigarettes/day.
Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
Patients with poor oral hygiene.
Any known allergies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odai A Hwafdeh, BDS
Organizational Affiliation
Master student
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nesma M Shemais, PhD
Organizational Affiliation
Lecturer of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mona S Darhous, PhD
Organizational Affiliation
Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
State/Province
Manial
ZIP/Postal Code
12311
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin
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