Back to resultsHyaluronic Acid Effect on Xenogenic Bone Healing
Primary Purpose
Bone Resorption, Tooth Loss
Status
Unknown status
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Ridge preservation: Tooth extration and immediat bone grafting in the socket
Sponsored by
About this trial
This is an interventional treatment trial for Bone Resorption focused on measuring tooth extraction, ridge preservation, hyaluronic acid, dental implant
Eligibility 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
Sites / Locations
- Saint-Joseph universityRecruiting
- Universte Saint Joseph-BeyrouthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Radiological assessement
Histomorphometric analysis
Arm Description
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
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
Outcomes
Primary Outcome Measures
Radiological assessement of the boe resorption
the baseline if the CBCT is compared to the 4 months post-op to assess the bone resorption
Histomorphometric analysis
During implant placement, a bone biopsy is harvested and stained with different colorants to assess microscopically the biological healing
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04377256
Brief Title
Hyaluronic Acid Effect on Xenogenic Bone Healing
Official Title
Hyaluronic Acid Effect on Xenogenic Bone Substitutes Healing During Ridge Preservations: A Radiological and Histomorphometric Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
January 10, 2021 (Anticipated)
Study Completion Date
May 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint-Joseph University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption, Tooth Loss
Keywords
tooth extraction, ridge preservation, hyaluronic acid, dental implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiological assessement
Arm Type
Experimental
Arm Description
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
Arm Title
Histomorphometric analysis
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Ridge preservation: Tooth extration and immediat bone grafting in the socket
Intervention Description
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 Measure Information:
Title
Radiological assessement of the boe resorption
Description
the baseline if the CBCT is compared to the 4 months post-op to assess the bone resorption
Time Frame
4 months
Title
Histomorphometric analysis
Description
During implant placement, a bone biopsy is harvested and stained with different colorants to assess microscopically the biological healing
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bachar A Husseini, DDS
Phone
+96181483610
Email
basharhusseini@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald J Younes, Phd
Organizational Affiliation
Head of oral surgery department, facuty of dentistry ,Universite SainT Joseph-Beyrouth
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bachar A Husseini, DDS
Organizational Affiliation
Department of oral surgery, facuty of dentistry ,Universite SainT Joseph-Beyrouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint-Joseph university
City
Beirut
ZIP/Postal Code
1104 2020
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Samaha, Librarian
Phone
9611421000
Ext
2211
Email
msamaha@usj.edu.lb
First Name & Middle Initial & Last Name & Degree
Carla Maria Khairallah, Masters in Oral Surgery
Facility Name
Universte Saint Joseph-Beyrouth
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bachar Husseini, DDS
Phone
+96181483610
Email
Basharhusseini@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Hyaluronic Acid Effect on Xenogenic Bone Healing
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