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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ridge Preservation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 23, 2022
Last Updated
August 31, 2023
Sponsor
Cairo University
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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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