Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

NCT ID: NCT05781529

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2021-08-31

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%

Conditions

Alveolar Ridge Enlargement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Alveolar ridge augmentation with injectable platelets rich fibrin

Intervention Type: PROCEDURE

Injectable platelets rich fibrin is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption

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

Group Type: EXPERIMENTAL

Alveolar ridge augmentation with hyaluronic acid

Intervention Type: PROCEDURE

Hyaluronic is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption

Xenograft

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

Group Type: ACTIVE_COMPARATOR

Alveolar ridge augmentation with xenograft

Intervention Type: PROCEDURE

Xenograft is added alone as a active compatator

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Alveolar ridge augmentation with xenograft

Xenograft is added alone as a active compatator

Intervention Type: PROCEDURE

Other Intervention Names

Socket augmentation with injectable platelets rich fibrin; Socket augmentation with hyaluronic acid; Socket augmentation with xenograft

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Doaa Adel Salah Khattab

Cairo, Abbassia, Egypt

Doaa Khattab

Cairo, Abbassia, Egypt

Countries

Egypt

References

Abaza G, Abdel Gaber HK, Afifi NS, Adel-Khattab D. Injectable platelet rich fibrin versus hyaluronic acid with bovine derived xenograft for alveolar ridge preservation. A randomized controlled clinical trial with histomorphometric analysis. Clin Implant Dent Relat Res. 2024 Feb;26(1):88-102. doi: 10.1111/cid.13289. Epub 2023 Oct 31.

Reference Type: DERIVED

PMID: 37905704 (View on PubMed)

Other Identifiers

21832

Identifier Type: -

Identifier Source: org_study_id