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Hyaluronic Acid Effect on Xenogenic Bone Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377256
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Saint-Joseph University

Brief Summary:

The aim of this study is to test the hyaluronic acid hydrogel impact on the healing acceleration of xenogenic bone substitutes used in ridge preservation.

Following tooth extraction, bone particles are mixed with the hyaluronic acid gel and grafted in the tooth socket. at the implant placement phase, a cone beam computer assisted tomography file is recorded in order to compare it with the baseline and a biopsy to evaluate the histological consequences.


Condition or disease Intervention/treatment Phase
Bone Resorption Tooth Loss Procedure: Ridge preservation: Tooth extration and immediat bone grafting in the socket Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyaluronic Acid Effect on Xenogenic Bone Substitutes Healing During Ridge Preservations: A Radiological and Histomorphometric Study
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : January 10, 2021
Estimated Study Completion Date : May 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiological assessement
Two CBCTs were recorded and compared, one at the baseline and the other at 4 months post-op. The bone resorption was quantified and analyzed using ITK-SNAP software
Procedure: Ridge preservation: Tooth extration and immediat bone grafting in the socket
Following the tooth extraction, the socket is filled with a mixture of xenogenic bone and hyaluronic acid and sealed with an epithelio-connective arrested from the maxillary palate

Experimental: Histomorphometric analysis
During implant placement (4 months after the bone grafting), a bone biopsy is collected and stained with several colorants to analyze the biological bone healing
Procedure: Ridge preservation: Tooth extration and immediat bone grafting in the socket
Following the tooth extraction, the socket is filled with a mixture of xenogenic bone and hyaluronic acid and sealed with an epithelio-connective arrested from the maxillary palate




Primary Outcome Measures :
  1. Radiological assessement of the boe resorption [ Time Frame: 4 months ]
    the baseline if the CBCT is compared to the 4 months post-op to assess the bone resorption

  2. Histomorphometric analysis [ Time Frame: 4 months ]
    During implant placement, a bone biopsy is harvested and stained with different colorants to assess microscopically the biological healing



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients in need of tooth extraction and willing to receive dental implants in the extraction site
  • Presence of two mono radicular teeth in need of extraction

Exclusion Criteria:

  • Patients with systemic diseases
  • Patients under 8 years and above 60 years.
  • Presence of endodontic or periodontal lesion in the extraction sites

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377256


Contacts
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Contact: Bachar A Husseini, DDS +96181483610 basharhusseini@hotmail.com

Locations
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Lebanon
Saint-Joseph university Recruiting
Beirut, Lebanon, 1104 2020
Contact: Maya Samaha, Librarian    9611421000 ext 2211    msamaha@usj.edu.lb   
Principal Investigator: Carla Maria Khairallah, Masters in Oral Surgery         
Universte Saint Joseph-Beyrouth Recruiting
Beirut, Lebanon
Contact: Bachar Husseini, DDS    +96181483610    Basharhusseini@hotmail.com   
Sponsors and Collaborators
Saint-Joseph University
Investigators
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Study Director: Ronald J Younes, Phd Head of oral surgery department, facuty of dentistry ,Universite SainT Joseph-Beyrouth
Principal Investigator: Bachar A Husseini, DDS Department of oral surgery, facuty of dentistry ,Universite SainT Joseph-Beyrouth
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Responsible Party: Saint-Joseph University
ClinicalTrials.gov Identifier: NCT04377256    
Other Study ID Numbers: USJ-2019-267
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saint-Joseph University:
tooth extraction
ridge preservation
hyaluronic acid
dental implant
Additional relevant MeSH terms:
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Bone Resorption
Tooth Loss
Bone Diseases
Musculoskeletal Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases