Hyaluronic Acid Effect on Xenogenic Bone Healing

May 3, 2020 updated by: Saint-Joseph University

Hyaluronic Acid Effect on Xenogenic Bone Substitutes Healing During Ridge Preservations: A Radiological and Histomorphometric Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Phase 4

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

  • Lebanon
      • Beirut, Lebanon, 1104 2020
        • Recruiting
        • Saint-Joseph University
        • Contact:
        • Principal Investigator:
          • Carla Maria Khairallah, Masters in Oral Surgery
      • Beirut, Lebanon
        • Recruiting
        • Universte Saint Joseph-Beyrouth
        • Contact:

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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months
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
4 months

Collaborators and Investigators

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

Sponsor

Saint-Joseph University

Investigators

  • 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

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)

May 1, 2020

Primary Completion (Anticipated)

January 10, 2021

Study Completion (Anticipated)

May 10, 2021

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 3, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 3, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USJ-2019-267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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