Evaluation of the efficiency of autologous albumin gel mixed with I-PRF and artificial bone graft in alveolar ridge preservation following tooth extraction

ISRCTN ISRCTN77480970
DOI https://doi.org/10.1186/ISRCTN77480970
Submission date
25/05/2024
Registration date
20/06/2024
Last edited
22/07/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
When a tooth is lost, the surrounding bone, known as the alveolar bone, begins to deteriorate. This process, termed alveolar bone resorption, results in a decrease in both the quantity and quality of the bone, leading to a reduction in its external width and height. Ridge preservation is a treatment carried out during or after tooth extraction to mitigate this bone loss. It aims to slow down bone resorption, promote new bone formation, and enhance the healing of both bone and surrounding soft tissues. Various biomaterials have been tested for ridge preservation, including autografts (bone from the same individual), bone substitutes, blood derivatives, and bioactive agents. Platelet-rich fibrin (PRF), a second-generation platelet concentrate, has shown promise in promoting tissue regeneration by enhancing blood vessel formation, stem cell capture, immune response, and tissue closure. However, PRF is rapidly absorbed, typically degrading within 10 to 14 days, which limits its effectiveness as a long-term barrier. Recent advancements have led to the development of an injectable albumin gel combined with PRF, which prolongs the material's absorption time to 4-6 months. This new compound leverages the benefits of PRF while offering a slower degradation rate, potentially providing more sustained support for bone and tissue regeneration. The purpose of this research is to evaluate the efficacy of this innovative injectable albumin gel mixed with PRF and artificial bone graft in preserving the alveolar ridge following tooth extraction. The study will focus on 1. assessing the pain experienced by patients during the treatment; 2. measuring the radiographic density of the newly formed bone; and, 3. analyzing the changes in the dimensions of the alveolar ridge, specifically the vestibular (cheek side) and lingual (tongue side) walls, six months post-surgery. Alveolar ridge resorption is a significant issue after dental extractions, leading to aesthetic and functional problems and complicating future dental implant placement. This study aims to offer a potential solution to enhance the preservation of the alveolar structure, thereby improving patient outcomes.

Who can participate?
Adult patients aged between 22 and 50 years old requiring the preservation of the alveolar structure following tooth extraction

What does the study involve?
This study aims to compare the effectiveness of two different combinations of treatments (one with autologous albumin gel and PRF, and the other with injectable PRF) in maintaining alveolar bone dimensions post-extraction.

What are the possible benefits and risks of participating?
The benefits gained from the procedure are improved healing and more bone. There are no risks after the application of bone graft.

Where is the study run from?
Damascus University (Syria)

When is the study starting and how long is it expected to run for?
August 2022 to April 2024

Who is funding the study?
Damascus University (Syria)

Who is the main contact?
Dr Zain Moalla, zainmoalla150@gmail.com

Contact information

Dr Zain Moalla
Public, Scientific, Principal Investigator

Damascus university, Mazzeh highway
Damascus
-
Syria

ORCiD logoORCID ID 0009-0001-6184-3699
Phone +963 94758006
Email zainmoalla150@gmail.com
Dr Zain Moalla
Principal Investigator

Damascus university, Mazzeh highway
Damascus
-
Syria

Phone +963 94758006
Email zainmoualla06@damascusuniversity.edu.sy

Study information

Study designComparative clinical trial with a split mouth technique
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)University/medical school/dental school
Study typeEfficacy
Participant information sheet No participant information sheet available
Scientific titleEvaluation of the efficiency of autologous albumin gel mixed with I-PRF and artificial bone graft in alveolar-ridge-preservation following tooth extraction
Study objectivesIs the application of autologous albumin gel mixed with injectable platelet-rich fibrin and artificial bone graft able to improve healing, relieve pain, prevent post-extraction alveolar bone resorption, and improve the bone density of new bone?
Ethics approval(s)

Approved 29/08/2022, Scientific Research and Postgraduate Studies Council (Baramkeh, Damascus, -, Syria; +963 1133923192; ap.srd@damascusuniversity.edu.sy), ref: 4243

Health condition(s) or problem(s) studiedSymmetrical teeth indicated for extraction
InterventionThe study aims to compare two different treatments for maintaining alveolar bone dimensions after tooth extraction. On one side, autologous albumin gel mixed with platelet-rich fibrin (PRF) and artificial bone graft will be applied, while on the opposite side, injectable platelet-rich fibrin (I-PRF) mixed with artificial bone graft will be used. To ensure unbiased results, the specific treatment for each side will be randomly assigned using Excel software, and blinding will be maintained by pulling papers to determine the treatment for each party. The intervention involves atraumatic extraction of two teeth from a single patient in one session, with each extraction taking 20-40 minutes. Both extraction sites will receive bone grafts, but with different PRF combinations to assess their effectiveness.
Intervention typeProcedure/Surgery
Primary outcome measure1. Radiographic Bone Density: ROI Region of Interest By drawing a rectangle in the extraction socket in the image taken six months after the alveolar ridge preservation procedure and recording the average value given, measured using the Ez3Di viewer program
2. Study of changes in alveolar bone dimensions: The two images are uploaded to the OnDemand3D program. We perform matching in the three axes - sagittal, frontal, and vertical - and then choose the appropriate section of the image in which the surgical intervention was performed.
3. Measuring vertical changes (alveolar ridge height): A line is drawn that connects the top of the vestibular plate to the top of the lingual or palatal plate, and from the middle of this line a line is drawn to the height of the socket. In this way, the vertical height of the socket is measured immediately after the extraction and six months after the extraction, and the amount of change that occurs is calculated after that.
4. Measuring horizontal bone changes (width of the alveolar ridge): Two horizontal lines are drawn at level 3 and level 5 mm from the edge of the alveolar bone on the image taken immediately after the extraction. These lines are fixed when measuring on the second image (six months later) after merging the two images together, and the amount is then calculated. The change is happening.
Secondary outcome measuresPain is measured using a visual analogue scale (VAS) at baseline 24, 48, and 72 h
Overall study start date29/08/2022
Completion date01/04/2024

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit22 Years
Upper age limit50 Years
SexBoth
Target number of participants12
Total final enrolment12
Key inclusion criteria1. There are no general diseases
2. There is no periodontitis
3. There is no contraindication for local anesthesia or oral surgery
4. Extraction socket type 1 according to Elian, 2007
Key exclusion criteria1. Pregnant and breastfeeding
2. The presence of an acute abscess or vestibular fistula in the work area
3. Smoker patient
4. Alcoholics
5. Taking medications that affect bone metabolism
Date of first enrolment01/02/2023
Date of final enrolment01/01/2024

Locations

Countries of recruitment

  • Syria

Study participating centre

Damascus University
Mazzeh highway
Damascus
-
Syria

Sponsor information

Damascus University
University/education

Mazzeh highway
Damascus
-
Syria

Phone +963981555778
Email damascusuniversity.edu.sy@gmail.com
Website http://www.damascusuniversity.edu.sy
ROR logo "ROR" https://ror.org/03m098d13

Funders

Funder type

University/education

Damascus University
Government organisation / Universities (academic only)
Alternative name(s)
University of Damascus, جَامِعَةُ دِمَشْقَ, DU
Location
Syria

Results and Publications

Intention to publish date31/12/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe dataset to be generated will be stored in a publicly available repository

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications Alveolar Ridge Preservation Using a Mixture of Alb-PRF and Alloplastic Bone Graft: A Case Report 13/03/2025 22/07/2025 Yes No

Editorial Notes

22/07/2025: Publication reference added.
20/06/2024: Study's existence confirmed by the Scientific Research and Postgraduate Studies Council of Damascus University.