Evaluation of Socket Preservation Using Autogenous Dentine Graft With Or Without Autologous Fibrin Glue

September 7, 2023 updated by: Islam Mohamed Sherif, Cairo University

Evaluation of Socket Preservation Using Autogenous Dentine Graft With Or Without Autologous Fibrin Glue: A Randomized Controlled Clinical Trial

  • The aim of this interventional study is to investigate the dimensional changes in buccolingual alveolar ridge width in socket preservation using sticky dentin vs dentin graft alone
  • The main question: is dentin graft mixed with autologous fibrin glue has better dimensional changes than using dentin graft alone ?
  • outcomes: Change in buccolingual alveolar ridge width as well as apico-coronal alveolar ridge height

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Aim of the study: The aim of this study is to investigate the dimensional changes in buccolingual alveolar ridge width. As well as the apico-coronal alveolar ridge height following tooth extraction when using sticky grafts combined with demineralized dentin grafts for socket preservation.
  • Research Procedure in brief:

This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University. *operative procedure: Before tooth extraction, probing depths (PD), gingival recession (GR), and bleeding on probing (BOP) will be assessed at six sites (mid-facial, mesio-facial, disto-facial, mid-palatal, mesio-palatal, and disto-palatal) around the tooth to be extracted and on the adjacent teeth to verify their periodontal status. Local anesthesia will be administered by infiltration to achieve the necessary anesthesia to allow extraction of the indicated tooth. Flapless atraumatic extraction will be done. Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries or restorations (if present), using a high-speed stone. The pulp chamber will be cleaned with sterile endodontic files. Then, teeth will be grinded to fine particles.

The particles prepared will be immersed tooth in alcohol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze.

Then the dentine graft particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze

Then the patient will be randomly assigned to one of the treatment groups:

In group 1 (control group) Demineralized dentine graft will be placed in the socket.

In group 2 (test group):

Sticky graft preparation will be done as follows:

  1. Small amount of patient's venous blood (8-10cc) is drawn via venipuncture, and the blood is placed into non-coated vacutainers to obtain autologous fibrin glue (AFG), which will make sticky graft.
  2. The blood in the test tubes is centrifuged at 2700-3000 rpm for 2-3 mins.
  3. The upper autologous fibrin glue is obtained with syringe and mixed with particulate of dentine graft and allows for 5-10 minutes for polymerization in order to produce sticky graft.

  4. The prepared sticky dentin graft will then be inserted in the socket.

    • Post operative radiograph:

Cone beam CT will be taken post surgically to measure the buccolingual dimension in the same day of the surgery.

*Post-surgical procedure: (six months after socket preservation) Another Cone beam CT will be taken to measure the outcomes by superimposition of the 2 CBCT

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • 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 Contact

Study Contact Backup

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Systemically healthy patients ≥18 years old
  • Nonsmoker
  • Teeth with root fracture, teeth with failed endodontic therapy or advanced caries
  • Intact extraction socket with no dehiscence or fenestration.

Exclusion Criteria:

  • Patients with systemic diseases.
  • Patients with dehiscence or fenestrations
  • Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
  • Patients with large distinct pre-apical pathology
  • Smokers of more than 10 cigarettes a day or equivalent to cigarettes
  • Breastfeeding or pregnant women
  • Patients without availability to attend follow-up visits or patients rejecting to sign the informed consent.

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
Intervention / Treatment
Experimental: dentin graft mixed with autologous fibrin glue
extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket
Procedure: dentin graft mixed with autologous fibrin glue
extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket using centrifuge
Active Comparator: dentin graft
extracted tooth will be grafted in the extracted socket
Procedure: dentin graft
extracted tooth will be grafted in the socket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in buccolingual alveolar ridge width dimensions immediately after tooth extraction (baseline) and ≥ 6 months after (follow-up).
Time Frame: 6 month
superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in apico-coronal alveolar ridge height immediately after tooth extraction and 6 months after
Time Frame: 6 months
superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Amr Zahran, Professor, Cairo 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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22623

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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