Comparison between two types of platelet concentrates for socket preservation after tooth extraction

ISRCTN	ISRCTN60191547
DOI	https://doi.org/10.1186/ISRCTN60191547
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Damascus University
Funder	Damascus University

Submission date: 24/11/2023
Registration date: 28/11/2023
Last edited: 07/07/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Healing of the socket after tooth extraction leads to ridge resorption (loss of bone in the jaw) that can make implant installation position difficult and negatively affect functional and aesthetic outcomes. Alveolar ridge preservation (ARP) is a procedure in which biomaterials are placed in the socket of the extracted tooth at the time of extraction to minimize changes in hard and soft tissue after tooth loss. The aim of this study is to determine the effect of leukocyte-platelet-rich fibrin (L-PRF) and titanium prepared platelet-rich fibrin (T-PRF) in comparison with spontaneous healing.

Who can participate?
Adult patients aged 18 years and over who had a treatment plan of extraction and alveolar ridge preservation.

What does the study involve?
Participants will be allocated to receive L-PRF, T-PRF, or no biomaterial placed within the socket after tooth extraction. At 4 months after surgery, the participants will undergo x-rays to evaluate the effectiveness of each method.

What are the possible benefits and risks of participating?
This study will determine the effectiveness of autologous biomaterials in reducing changes in hard and soft tissue after tooth loss and compare it with not applying any material within the socket. There is a risk of not achieving good results in some cases, however, the study team can manage these cases with another method.

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

When is the study starting and how long is it expected to run for?
April 2023 to November 2024

Who is funding the study?
Damascus University (Syria)

Who is the main contact?
Dr Emad Aldemmari, emadalddenaldemmari@gmail.com

Contact information

Dr Emad Aldden Aldemmari
Public, Scientific, Principal investigator

Damascus University
Al-Mazzeh Highway
Damascus
00000
Syria

Phone	+963 (0)932450412
Email	emadalddenaldemmari@gmail.com

Study information

Primary study design	Interventional
Study design	Comparative interventional randomized controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of using T-PRF for alveolar ridge preservation: a randomized controlled trial
Study objectives	Is there a difference between applying platelet-rich fibrin and not applying it (spontaneous healing), and is there a difference between leukocyte-platelet-rich fibrin (L-PRF) and titanium prepared platelet-rich fibrin (T-PRF) fibrin when applied after extraction to preserve the alveolar ridge?
Ethics approval(s)	Approved 04/06/2023, Scientific Research Committee (Faculty of Dentistry, Damascus University, Mazzeh Highway, Damascus, 00000, Syria; +963 (0)113341864; manager@hcsr.gov.sy), ref: 22749
Health condition(s) or problem(s) studied	Alveolar ridge preservation
Intervention	Informed consent will be obtained by investigators participating in the study, and cases will be diagnosed clinically and radiographically to ensure the matching of inclusion criteria. On the day of surgery, participants will be randomized to the control, L-PRF, or T-PRF group by one investigator using a computer-generated randomization scheme. After sulcular incisions without flap reflection, teeth will be extracted atraumatically utilizing periotomes with care to preserve the buccal bone plate and the surrounding soft tissues. Following debridement, the socket will be closed with 4-0 non-resorbable sutures in control group (spontaneous healing), the socket will be filled with L-PRF (prepared by centrifugation of blood for 12 min at 2700 rpm) and will be closed with 4-0 non-resorbable sutures in L-PRF group, or the socket will be filled with T-PRF (prepared by centrifugation of blood for 12 min at 2800 rpm) and will be closed with 4-0 non-resorbable sutures in T-PRF group.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Current primary outcome measure as of 24/03/2025: 1. Width of Alveolar Ridge: Superimposition between pre-treatment and 4-month post-intervention CBCT images was performed using Ondemand 3D software The measurements were conducted at three levels (4, 7, and 10 mm). _____ Previous primary outcome measure as of 13/02/2025: 1. Width of Alveolar Ridge: Superimposition between pre-treatment and 4-month post-intervention CBCT images was performed using Ondemand 3D software. A pre-fabricated stent was not used for this purpose. The measurements were conducted at three levels (4, 7, and 10 mm). 2. Vertical Height to the Buccal and Palatal Alveolar Bone: Superimposition between pre-treatment and 4-month post-intervention CBCT images was performed using Ondemand 3D software to measure vertical resorption on the buccal and palatal sides. A pre-fabricated stent was not used for this purpose. 3. Radiographic Bone Density: Radiographic bone density was measured after 4 months using EZ-3D Plus software for CBCT analysis. The entire socket area was evaluated using the "Region of Interest" feature. A pre-fabricated stent was not used for this purpose. _____ Previous primary outcome measure: 1. Width of alveolar ridge: at three levels (4, 7, and 10 mm), the distance between the two horizontal buccal and palatal points located at the same level. Measured using a pre-fabricated stent before extraction and 4 months after the alveolar ridge preservation. 2. Vertical height to the buccal and palatal alveolar bone: the distance between the buccal/palatal crest to the vertical point, measured using a pre-fabricated stent before extraction and 4 months after the alveolar ridge preservation. 3. Thickness of the buccal (BPT) and palatal/lingual (PPT) alveolar plates: measured using a pre-fabricated stent at the first sectional CBCT scan (before extraction). 4. Radiographic bone density: at three levels (4,7, and 10 mm), the mean density values in the three levels are taken, measured using a pre-fabricated stent after 4 months of the alveolar ridge preservation. 5. Buccal soft tissue thickness: measured using a pre-fabricated stent and its clinical reference points with the addition of an endodontic spreader with rubber stops, recorded before extraction and 4 months after the alveolar ridge preservation.
Key secondary outcome measure(s)	Current secondary outcome measures as of 24/03/2025: 1. Vertical Height to the Buccal and Palatal Alveolar Bone: Superimposition between pre-treatment and 4-month post-intervention CBCT images was performed using Ondemand 3D software to measure vertical resorption on the buccal and palatal sides. 2. Radiographic Bone Density: Radiographic bone density was measured after 4 months using Ondemand 3D software for CBCT analysis. 3. Wound healing recorded using the Landry Wound Healing Index weekly during the first month after the alveolar ridge preservation 4. Pain measured using visual analog scale (VAS) and the number of analgesics, recorded daily during the first week after the alveolar ridge preservation 5. Complications after tooth extraction, recorded (if present) as soon as the patient reports it. 6. Periodontal Probing Depth (PPD) and Gingival Recession (GR): Measured before extraction and at 4 months post-extraction using a UNC-15 periodontal probe at the extraction site and the adjacent mesial and distal teeth. 7. Keratinized Tissue Width (KTW): Measured using a UNC-15 periodontal probe from the gingival margin to the mucogingival junction (MGJ) at the extraction site, before extraction and at 4 months post-extraction. _____ Previous secondary outcome measures as of 14/02/2025: 1. Wound healing and complete wound epithelization recorded using the Landry Wound Healing Index weekly during the first month after the alveolar ridge preservation 2. Pain measured using visual analog scale (VAS) and the number of analgesics, recorded daily during the first week after the alveolar ridge preservation 3. Complications after tooth extraction, recorded (if present) as soon as the patient reports it. _____ Previous secondary outcome measures: 1. Wound healing recorded using the Landry Wound Healing Index weekly during the first month after the alveolar ridge preservation 2. Complete wound epithelization recorded by application of toluidine blue weekly during the first month after the alveolar ridge preservation 3. Pain measured using visual analog scale (VAS) and the number of analgesics, recorded daily during the first week after the alveolar ridge preservation 4. Complications after tooth extraction, recorded (if present) as soon as the patient reports it.
Completion date	05/11/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	56 Years
Sex	All
Target sample size at registration	20
Total final enrolment	30
Key inclusion criteria	Current inclusion criteria as of 13/02/2025: 1. Patients with a single rooted tooth in the maxillary arch who had a treatment plan of extraction and alveolar ridge preservation with no evidence of acute infection such as severe swelling, suppuration, abscess, and/or spontaneous bleeding, and the teeth adjacent to the tooth to be extracted must be present 2. At least 18 years old 3. Non-smoker 4. Participants treated for periodontal disease 5. Participants that show the presence of buccal plate at the extraction site as determined by a sectional cone-beam computed tomography (CBCT) scan. If the patient qualified based on the CBCT scan 6. Participants with excellent oral health (20% or less of plaque index) 7. Participants with 2 mm at least of keratinized tissue at the surgical site _____ Previous inclusion criteria: 1. Patients with a single rooted tooth in the maxillary arch who had a treatment plan of extraction and alveolar ridge preservation with no evidence of acute infection such as severe swelling, suppuration, abscess, and/or spontaneous bleeding, and the teeth adjacent to the tooth to be extracted must be present 2. At least 18 years old 3. Participants smoke fewer than 10 cigarettes per day 4. Participants treated for periodontal disease 5. Participants that show the presence of buccal plate at the extraction site as determined by a sectional cone-beam computed tomography (CBCT) scan. If the patient qualified based on the CBCT scan 6. Participants with excellent oral health (20% or less of plaque index) 7. Participants with 2 mm at least of keratinized tissue at the surgical site
Key exclusion criteria	1. Lactating or pregnant female 2. Medical conditions that are contraindicated with periodontal surgery 3. Use anticoagulant drugs or steroids 4. Bleeding disorders 5. Autoimmune or immune proliferative disorders 6. Acute inflammation
Date of first enrolment	02/01/2024
Date of final enrolment	01/09/2024

Locations

Countries of recruitment

Syria

Study participating centre

Damascus University

Faculty of Dentistry
Al-Mazzeh highway
Damascus
00000
Syria

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available on request from Dr Emad Aldemmari (emadalddenaldemmari@gmail.com) and in the publication related to it after the end of the research. Type of data that will be shared: demographic information (age, gender), location of the tooth to be extracted, clinical and radiographical measurements, photos of clinical procedure.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		05/07/2025	07/07/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/07/2025: Publication reference and total final enrolment added.
24/03/2025: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
14/02/2025: The secondary outcome measures were changed.
13/02/2025: The following changes were made to the trial record:
1. The overall end date was changed from 03/10/2024 to 05/11/2024.
2. The intention to publish date was changed from 01/08/2024 to 01/02/2025.
3. The primary outcome measures were changed.
4. The inclusion criteria were changed.
27/11/2023: Study's existence confirmed by the University of Damascus.