Comparison between two types of platelet concentrates for socket preservation after tooth extraction
| ISRCTN | ISRCTN60191547 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60191547 |
- 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
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
Public, Scientific, Principal Investigator
Damascus University
Al-Mazzeh Highway
Damascus
00000
Syria
| Phone | +963 (0)932450412 |
|---|---|
| emadalddenaldemmari@gmail.com |
Study information
| Study design | Comparative interventional randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Prevention, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 09/04/2023 |
| Completion date | 05/11/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 56 Years |
| Sex | Both |
| Target number of participants | Between 20 and 35 patients |
| 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
Al-Mazzeh highway
Damascus
00000
Syria
Sponsor information
University/education
Al-Mazzeh Highway
Damascus
00000
Syria
| Phone | +963 (0)113341864 |
|---|---|
| manager@hcsr.gov.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the research results. |
| 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 |
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.
