NCT04377256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

May 3, 2020

Last Update Submit

March 31, 2025

Conditions

Keywords

tooth extractionridge preservationhyaluronic aciddental implant

Outcome Measures

Primary Outcomes (2)

  • Radiological assessement of the boe resorption

    the baseline if the CBCT is compared to the 4 months post-op to assess the bone resorption

    4 months

  • Histomorphometric analysis

    During implant placement, a bone biopsy is harvested and stained with different colorants to assess microscopically the biological healing

    4 months

Study Arms (2)

Radiological assessement

EXPERIMENTAL

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

Histomorphometric analysis

EXPERIMENTAL

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

Interventions

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

Histomorphometric analysisRadiological assessement

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint-Joseph university

Beirut, Lebanon, 1104 2020, Lebanon

Location

Universte Saint Joseph-Beyrouth

Beirut, Lebanon

Location

MeSH Terms

Conditions

Bone ResorptionTooth Loss

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Ronald J Younes, Phd

    Head of oral surgery department, facuty of dentistry ,Universite SainT Joseph-Beyrouth

    STUDY DIRECTOR
  • Bachar A Husseini, DDS

    Department of oral surgery, facuty of dentistry ,Universite SainT Joseph-Beyrouth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 6, 2020

Study Start

May 1, 2020

Primary Completion

January 10, 2021

Study Completion

May 10, 2021

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations