Does i-PRF (injectable platelet-rich fibrin) improve the quality of periodontal tissue and accelerate orthodontic tooth movement?
| ISRCTN | ISRCTN12737239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12737239 |
| Secondary identifying numbers | 2723 |
- Submission date
- 09/04/2024
- Registration date
- 15/04/2024
- Last edited
- 17/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Mandibular incisor crowding is a frequent issue that prompts many adults to seek orthodontic treatment. When teeth are crowded together, it can lead to various problems such as the wearing away of the roots, a reduction in the height and density of the bone on the outer side of the teeth, gaps forming between teeth, and the development of window-like gaps in the bone. Additionally, the width of the protective tissue around the teeth may decrease.
Platelet-rich concentrates, like injectable platelet-rich fibrin, have been shown to have positive effects on both soft and hard tissue healing. They may serve as a beneficial self-derived material to prevent these complications.
Who can participate?
Adults aged 18-28 years old with skeletal class I malocclusion.
What does the study involve?
Participants will be divided randomly into three groups:
1. Experimental Group 1: In this group, platelet-rich fibrin (I-PRF) will be injected once into the space between the cheeks and the teeth on the lower jaw, specifically around the mandibular incisors.
2. Experimental Group 2: In this group, platelet-rich fibrin (I-PRF) will be injected four times into the same area around the mandibular incisors, with a 30-day gap between each session.
3. Control Group: Participants in this group will receive injections of a saline solution into the same area around the mandibular incisors. This is done to prevent any tingling sensation that might occur.
What are the possible benefits and risks of participating?
Using this modified device may enhance the efficiency of crowded incisor alignment. There are no expected risks of participating.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
June 2022 to April 2025
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mohamad Idris, mohammad.idris@damascusuniversity.edu.sy, mohamad.ed.1997@gmail.com
Contact information
Public, Scientific, Principal Investigator
Department of orthodontics
Faculty of Dentistry
Damascus University
Al-Mazzeh St.
Damascus
0004
Syria
 ORCID ID |
0009-0009-6542-3040 |
|---|---|
| Phone | +963 964366915 |
| mohammad.idris@damascusuniversity.edu.sy |
Scientific
Department of orthodontics
Faculty of Dentistry
Damascus University
Al-Mazzeh St.
Damascus
0004
Syria
| ORCID ID |
0000-0002-0727-2653 |
|---|---|
| Phone | +963 944302075 |
| dr.burhan-a@hotmail.com |
Study information
| Study design | Interventional single-center single-blinded randomized parallel-group controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Effect of repeated injection of platelet-rich fibrin on crowded mandibular incisor alignment efficiency: a randomized controlled clinical trial |
| Study acronym | i-PRF |
| Study hypothesis | 1. I-PRF enhances the efficiency of crowded mandibular incisor alignment. 2. I-PRF accelerates orthodontic tooth movement. |
| Ethics approval(s) |
Approved 20/06/2022, Scientific research and postgraduate studies council of Damascus University (Mazzeh highway, Damascus, 80789, Syria; +963 (0)993303359; ap.srd@damascusuniversity.edu.sy), ref: 2723 |
| Condition | Malocclusion, Angle Class I; Crowded Teeth |
| Intervention | Patients will be randomly allocated into two groups using Microsoft® Excel electronic randomization: Arm 1: Experimental group 1: I-prf will injected in the buccal sulcus of the mandibular incisors 1 session directly after lower arch bracket adhesive. Orthodontic wires will be sequenced till reach to 19×25 ss. Arm 2: Experimental group 2: I-prf will injected in the buccal sulcus of the mandibular incisors 4 sessions with 30-day interval. Orthodontic wires will be sequenced till reach to 19×25 ss. Arm 3: Control group: . Saline serum will injected in the buccal sulcus of the mandibular incisors, to avoid the tingling effect. Orthodontic wires will be sequenced till reach to 19×25 ss. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Platelet-rich fibrin |
| Primary outcome measure | Dentoalveolar changes before and after treatment will be assessed using cone-beam computed tomography: 1. Dentoalveolar changes including: 1.1. Dehiscence in the buccal alveolar bone. 1.2. Fenestration in the buccal alveolar bone. 1.3. Height and thickness of alveolar bone. 2. Keratinized tissue width. 3. Lower arch alignment time. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 20/06/2022 |
| Overall study end date | 24/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 28 Years |
| Sex | Both |
| Target number of participants | 54 |
| Total final enrolment | 54 |
| Participant inclusion criteria | 1. Adult patients. 2. Class I malocclusion with moderate crowding (4-6) mm. 3. Good oral hygiene and periodontal health. 4. No severe skeletal discrepancy. 5. Normal or inclination for the upper and lower incisors. 6. No congenitally missing or extracted teeth (except for the third molars). |
| Participant exclusion criteria | 1. Patients with syndromes or craniofacial abnormalities. 2. Patients with vertical growth patterns. 3. Poor oral hygiene. 4. Previous orthodontic treatment. |
| Recruitment start date | 01/08/2023 |
| Recruitment end date | 04/04/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Faculty of Dentistry
Al-Mazzeh St.
Damascus
80789
Syria
Sponsor information
University/education
Mazzeh Street
Damascus
80789
Syria
| Phone | +963 (11) 339 23223 |
|---|---|
| ap.srd@damascusuniversity.edu.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 | 12/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
17/09/2024: The total final enrolment was added.
16/09/2024: Contact details updated.
15/04/2024: Trial's existence confirmed by Scientific research and postgraduate studies council of Damascus University.
