Sticky Bone Compared to A-PRF(Platlet Rich Fibrin) Effect on Alveolar Ridge Preservation

ALLOGRAFT Clinical Trial

Official title:

Autologous Fibrin Glue Mixed With Bone Graft(Sticky Bone) and Advanced Platelet Rich Fibrin Compared to Conventional Alveolar Ridge Preservation Technique : Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05536492
• Other study ID #: PHRC/HC/1087/22
• Status: Completed
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Arab American University (Palestine)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this research investigators are going to detect the effect of using different type of materials(sticky bone\platlet rich fibrin ) compared to normal healing on the dimensional changes of alveolar crest after single rooted tooth extraction by using CBCT (cone-beam computed tomography) at time of extraction and after 16-24 weeks

Description:

Patients who are treated and referred for having extractions in the upper and lower arch for single rooted teeth will have CBCT for each patient at time of extraction (T0) and after 3 months (T1) , by using the cross sectional of the CBCT investigators will measure the difference from the middle of the socket to buccal and palatal\lingual walls at 3 different points below the crest 1mm, 3mm , 5mm .

• the thickness of the buccal bone at baseline (T0) at 1, 3 and 5 mm below the crest

• the horizontal ridge width at crest- 1 mm (HW- 1 mm), crest- 3 mm (HW- 3 mm) and crest- 5 mm (HW- 5 mm) at the buccal/palatal side, in millimetres and later transformed to percentages

• the vertical resorption on both buccal and palatal side, in millimetres

• the socket fill defined as the highest point of viewable mineralized bone at the middle of the socket; absolute values (in mm) and percentages were calculated by comparing the initial depth of the socket and the depth after three months of healing preparation of the materials to be augmented : autologous fibrin glue mixed with bone graft(sticky bone) would be prepared by using green tubes by choukroun company centrifuged at 1300 rpm for 14 minutes (using DUE centrifuge) then mixed with 0.5 cc FDBA and the exudate of the compressed A-PRF then applied to the extraction site A-PRF PLUGS will be prepared using red tubes using venous blood centrifuged at 1300 rpm for 14 min , then the compressed using special tray and applied in the extraction sockets

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 1, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• presence of the buccal and palatal/lingual bony walls evaluated clinically by measuring the thickness of the alveolar ridge and radiologically by a CBCT , and residual periodontal attachment of at least 6 mm of single rooted tooth

Exclusion Criteria:

• complicated tooth extraction, and any medical problem that could interfere with the mucosal and bony healing processes or contraindicating an implant placement, such as anticoagulation, antiaggregatory medication, radiotherapy, bisphosphonate therapy, diabetes, endocarditis risk factors, immunosuppression, and renal or hepatic failure

Related Conditions & MeSH terms

• ALLOGRAFT

Intervention

Procedure:
• A-PRF
EXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF
• ALLOGRAFT
EXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF + ALLOGRAFT

Locations

Country	Name	City	State
Palestinian Territory, occupied	ArabAmericanU	Ramallah	West Bank

Sponsors (1)

Lead Sponsor	Collaborator
Arab American University (Palestine)

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RIDGE DIMENSIONS	USING CBCT	4 Months
Primary	BONE DENSITY	USING CBCT	4 MONTHS