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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06027528

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Unrestorable Dentition	Procedure: dentin graft mixed with autologous fibrin glue Procedure: dentin graft	N/A

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:

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.
The blood in the test tubes is centrifuged at 2700-3000 rpm for 2-3 mins.
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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.