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

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

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

Study Overview

• Status: Completed
• Conditions: A-PRF; ALLOGRAFT
• Intervention / Treatment: Procedure: A-PRF; Procedure: ALLOGRAFT

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • West Bank
    • Ramallah, West Bank, Palestinian Territory, occupied
      • ArabAmericanU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: G1-Control group; normal socket healing after extraction without intervention
Experimental: G2; SOCKET AUGMENTATION WITH A-PRF ALONE	Procedure: A-PRF; EXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF
Experimental: G3; SOCKET AUGMENTATION WITH A-PRF + ALLOGRAFT	Procedure: A-PRF; EXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF; Procedure: ALLOGRAFT; EXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF + ALLOGRAFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RIDGE DIMENSIONS	USING CBCT	4 Months
BONE DENSITY	USING CBCT	4 MONTHS

Collaborators and Investigators

• Sponsor: Arab American University (Palestine)

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PHRC/HC/1087/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No