Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

March 12, 2023 updated by: Ain Shams University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 months postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
4 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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