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Completed

NCT Number: NCT05781529

Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doaa Adel Salah Khattab, Cairo, Abbassia, Egypt

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About this study

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%

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alveolar ridge augmentation with injectable platelets rich fibrin

Procedure

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

Alveolar ridge augmentation with hyaluronic acid

Procedure

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

Alveolar ridge augmentation with xenograft

Procedure

Xenograft is added alone as a active compatator

Other names: Socket augmentation with xenograft

Primary outcomes

  1. Radiographic bone width

    Time frame: 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 outcomes

  1. histological and histomorphometric assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2023
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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