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Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

Primary Purpose

Alveolar Ridge Enlargement

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Alveolar ridge augmentation with injectable platelets rich fibrin
Alveolar ridge augmentation with hyaluronic acid
Alveolar ridge augmentation with xenograft
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Ridge Enlargement

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar) socket type I according to Elian et al., 2007 classification tooth to be extracted was free from acute periapical infection or sinus tracts thick gingival biotype Systemically free according to modified Cornell medical index Exclusion Criteria: smokers patients bruxism habits patients with poor oral hygiene or not willing to perform oral hygiene measures

Sites / Locations

  • Doaa Adel Salah Khattab
  • Doaa Khattab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Injectable platelets rich fibrin

Hyaluronic acid

Xenograft

Arm Description

Injectable platelets rich fibrin was prepared where 10 ml of patient venous blood was centrifuged without anti-coagulants (plain plastic glass-coated) at 700 rpm speed for only 3 minutes, xenograft was mixed with I-PRF to make sticky bone, sticky bone was placed into extraction socket till the socket was fully filled up to the gingival margin

Hyaluronic acid (HA) syringe containing 1 mL of cross-linked hyaluronic at a concentration of 20 mg/ml in a saline phosphate buffer solution at sterilized content was used. HA was mixed with particulate xenograft 1:10 ratio to form a putty consistency for condensation and was placed into extraction socket till the socket was fully filled up to the gingival margin

Xenograft was mixed with saline, placed in extraction socket till the socket is fully filled up to the gingival margin

Outcomes

Primary Outcome Measures

Radiographic bone width
Cone beam CT (CBCT) were obtained preoperatively and 4 months postoperatively. The radiographs were analyzed using One- Viewer viewing software (iCATVision). The buccolingual width was measured into different levels. At the bone crest (A), 3mm from the bone crest (B) and 6 mm from the bone crest (C). For standardization in the sagittal slice, the axial plane was adjusted to pass through the cemento enamel junction (CEJ) of the adjacent teeth. On the axial slice, the mesiodistal dimension from the distal surface to mesial surface of the adjeceent teeth was measured. The coronal plane was adjusted to be pass through the middle of the distance in order to be perpendicular to both buccal and lingual cortices. Measurement were all performed on the coronal slices. In addition, fusion was done by superimposing preoperative and 4 months CBCT in all groups.

Secondary Outcome Measures

histological and histomorphometric assessment
The biopsy samples were harvested and processed. All samples were serially sectioned using a microtome. Slides were stained separately with hematoxylin and eosin and observed using a light microscope. For histological evaluation and histomorphometric analysis, 20 photomicrographs from different sections taken at every 200 µm of each biopsy sample were captured at original magnification 10×, 20×, and 40× using a digital camera. The image analyzer was calibrated to automatically convert the measurement units (pixels) produced by the image analyzer program into actual micrometer units. Data from the sections of each group were averaged.

Full Information

First Posted
February 28, 2023
Last Updated
March 12, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05781529
Brief Title
Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation
Official Title
Injectable Platelets Rich Fibrin Versus Hyaluronic Acid With Bovine Derived Xenograft for Alveolar Ridge Preservation (A Randomized Controlled Clinical Trial With Histomorphometric Analysis)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate.
Detailed Description
The aim of this study was to compare injectable platelets rich fibrin (I-PRF) versus hyaluronic acid (HA) in combination with xenografts for ARP. Methods: Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate. The assessment was done by cone beam CT preoperative and 4 months postoperative to assess radiographic bone gain and crestal bone loss. Clinical parameters were soft tissue thickness, keratinized gingiva and clinical bone width that were assessed preoperative, 4 months and 1 year postoperative. Histological assessment of core bone biopsies 4 months postoperatively was performed by histomorphometric analysis of newly formed bone %, mature bone% and residual graft%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Ridge Enlargement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injectable platelets rich fibrin
Arm Type
Experimental
Arm Description
Injectable platelets rich fibrin was prepared where 10 ml of patient venous blood was centrifuged without anti-coagulants (plain plastic glass-coated) at 700 rpm speed for only 3 minutes, xenograft was mixed with I-PRF to make sticky bone, sticky bone was placed into extraction socket till the socket was fully filled up to the gingival margin
Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
Hyaluronic acid (HA) syringe containing 1 mL of cross-linked hyaluronic at a concentration of 20 mg/ml in a saline phosphate buffer solution at sterilized content was used. HA was mixed with particulate xenograft 1:10 ratio to form a putty consistency for condensation and was placed into extraction socket till the socket was fully filled up to the gingival margin
Arm Title
Xenograft
Arm Type
Active Comparator
Arm Description
Xenograft was mixed with saline, placed in extraction socket till the socket is fully filled up to the gingival margin
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge augmentation with injectable platelets rich fibrin
Other Intervention Name(s)
Socket augmentation with injectable platelets rich fibrin
Intervention Description
Injectable platelets rich fibrin is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge augmentation with hyaluronic acid
Other Intervention Name(s)
Socket augmentation with hyaluronic acid
Intervention Description
Hyaluronic is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge augmentation with xenograft
Other Intervention Name(s)
Socket augmentation with xenograft
Intervention Description
Xenograft is added alone as a active compatator
Primary Outcome Measure Information:
Title
Radiographic bone width
Description
Cone beam CT (CBCT) were obtained preoperatively and 4 months postoperatively. The radiographs were analyzed using One- Viewer viewing software (iCATVision). The buccolingual width was measured into different levels. At the bone crest (A), 3mm from the bone crest (B) and 6 mm from the bone crest (C). For standardization in the sagittal slice, the axial plane was adjusted to pass through the cemento enamel junction (CEJ) of the adjacent teeth. On the axial slice, the mesiodistal dimension from the distal surface to mesial surface of the adjeceent teeth was measured. The coronal plane was adjusted to be pass through the middle of the distance in order to be perpendicular to both buccal and lingual cortices. Measurement were all performed on the coronal slices. In addition, fusion was done by superimposing preoperative and 4 months CBCT in all groups.
Time Frame
4 months postoperative
Secondary Outcome Measure Information:
Title
histological and histomorphometric assessment
Description
The biopsy samples were harvested and processed. All samples were serially sectioned using a microtome. Slides were stained separately with hematoxylin and eosin and observed using a light microscope. For histological evaluation and histomorphometric analysis, 20 photomicrographs from different sections taken at every 200 µm of each biopsy sample were captured at original magnification 10×, 20×, and 40× using a digital camera. The image analyzer was calibrated to automatically convert the measurement units (pixels) produced by the image analyzer program into actual micrometer units. Data from the sections of each group were averaged.
Time Frame
4 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar) socket type I according to Elian et al., 2007 classification tooth to be extracted was free from acute periapical infection or sinus tracts thick gingival biotype Systemically free according to modified Cornell medical index Exclusion Criteria: smokers patients bruxism habits patients with poor oral hygiene or not willing to perform oral hygiene measures
Facility Information:
Facility Name
Doaa Adel Salah Khattab
City
Cairo
State/Province
Abbassia
ZIP/Postal Code
11566
Country
Egypt
Facility Name
Doaa Khattab
City
Cairo
State/Province
Abbassia
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

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