Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05781529

Collaborator

(none)

Enrollment

Locations

Arms

29.9

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alveolar Ridge Enlargement	Procedure: Alveolar ridge augmentation with injectable platelets rich fibrin Procedure: Alveolar ridge augmentation with hyaluronic acid Procedure: Alveolar ridge augmentation with xenograft	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Mar 6, 2019

Actual Primary Completion Date :

Jul 16, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Doaa Adel Salah Khattab	Cairo	Abbassia	Egypt	11566
2	Doaa Khattab	Cairo	Abbassia	Egypt	11566

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ain Shams University

ClinicalTrials.gov Identifier:

NCT05781529

Other Study ID Numbers:

21832

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hypertrophy

Hyaluronic Acid

Study Results

No Results Posted as of Mar 23, 2023