Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

Not Applicable

Completed

• Conditions: Alveolar Ridge Enlargement
• Interventions: Procedure: Alveolar ridge augmentation with hyaluronic acid; Procedure: Alveolar ridge augmentation with xenograft; Procedure: Alveolar ridge augmentation with injectable platelets rich fibrin

• Registration Number: NCT05781529
• Lead Sponsor: Ain Shams University

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%

Study Timeline

• Study Start: 2019-03-06
• Primary Completion: 2021-07-16
• Study Completion: 2021-08-31
• Study First Submitted: 2023-02-28
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-12
• Last Update Submitted: 2023-03-12
• Study First Posted: 2023-03-23
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid	Alveolar ridge augmentation with 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
Xenograft	Alveolar ridge augmentation with xenograft	Xenograft was mixed with saline, placed in extraction socket till the socket is fully filled up to the gingival margin
Injectable platelets rich fibrin	Alveolar ridge augmentation with 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

Primary Outcome Measures

Name	Time	Method
Radiographic bone width	4 months postoperative	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

Name	Time	Method
histological and histomorphometric assessment	4 months postoperative	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.

Trial Locations

Locations (2)

Doaa Adel Salah Khattab; 🇪🇬 Cairo, Abbassia, Egypt

Doaa Khattab; 🇪🇬 Cairo, Abbassia, Egypt