Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

Injectable Platelets Rich Fibrin Versus Hyaluronic Acid With Bovine Derived Xenograft for Alveolar Ridge Preservation (A Randomized Controlled Clinical Trial With Histomorphometric Analysis)

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Ridge Enlargement
• Intervention / Treatment: Procedure: Alveolar ridge augmentation with injectable platelets rich fibrin; Procedure: Alveolar ridge augmentation with hyaluronic acid; Procedure: Alveolar ridge augmentation with xenograft

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%

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 11566
      • Doaa Khattab
    • Cairo, Abbassia, Egypt, 11566
      • Doaa Adel Salah Khattab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injectable platelets rich fibrin; 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	Procedure: Alveolar ridge augmentation with injectable platelets rich fibrin; Injectable platelets rich fibrin is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption; Other Names: Socket augmentation with injectable platelets rich fibrin
Experimental: Hyaluronic acid; 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	Procedure: Alveolar ridge augmentation with hyaluronic acid; Hyaluronic is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption; Other Names: Socket augmentation with hyaluronic acid
Active Comparator: Xenograft; Xenograft was mixed with saline, placed in extraction socket till the socket is fully filled up to the gingival margin	Procedure: Alveolar ridge augmentation with xenograft; Xenograft is added alone as a active compatator; Other Names: Socket augmentation with xenograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 21832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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