Platelet-rich plasma injections and periodontal health
| ISRCTN | ISRCTN18306557 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18306557 |
| Secondary identifying numbers | 2608 |
- Submission date
- 29/08/2024
- Registration date
- 30/08/2024
- Last edited
- 30/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The aim of this study was to evaluate the effects of platelet-rich plasma (PRP) injections, a method of accelerating orthodontic tooth movement, on the health of periodontal (gum) tissues.
Who can participate?
Patients aged 18 to 25 years with anterior teeth crowding.
What does the study involve?
Participants are randomly assigned to either the PRP group or the control group. The PRP group received PRP injections at 0, 7, and 14 days, while the control group received standard orthodontic treatment without additional interventions. Periodontal health was evaluated at the start of the study and after 4, 8 and 12 weeks.
What are the possible benefits and risks of participating?
This study will evaluate the effects of PRP injection to accelerate orthodontic tooth movement on periodontal health. There is a risk of not achieving optimal results in some cases but the study team can manage these cases with alternative methods.
Where is the study run from?
Tishreen University (Syria)
When is the study starting and how long is it expected to run for?
November 2021 to August 2023
Who is funding the study?
Tishreen University (Syria)
Who is the main contact?
Dr May Alel, akeelmai035@gmail.com
Contact information
Public, Scientific, Principal Investigator
Lattakia
Lattakia
00000
Syria
 ORCID ID |
0009-0002-8191-8472 |
|---|---|
| Phone | +963 (0)992964458 |
| akeelmai035@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 | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Platelet-rich plasma injections and periodontal health: effects during accelerated orthodontic tooth movement |
| Study objectives | Does platelet-rich plasma injections during accelerated orthodontic tooth movement affect periodontal health |
| Ethics approval(s) |
Approved 07/12/2021, Tishreen University ethics committee (Lattakia, Lattakia, 0000, Syria; +963 (0)41420291; info@tishreen.edu.sy), ref: 2068 |
| Health condition(s) or problem(s) studied | Anterior teeth crowding |
| Intervention | Participants are randomly assigned to either the PRP group or the control group. Randomization was achieved using sealed envelopes containing the allocation sequence, ensuring that treatment assignments remained concealed from both researchers and participants until the designated phase of the study. The randomization sequence was generated by an independent academic specialist. The PRP group received PRP injections at 0, 7, and 14 days, prepared using the double-spin method, while the control group received standard orthodontic treatment without additional interventions. Periodontal health parameters were evaluated at baseline and at 4, 8 and 12 weeks. Aspartate aminotransferase (AST) levels were assessed at baseline, 1 hour, 1 day, 7 days, and 14 days. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Salivary aspartate aminotransferase (AST) activity measured using a spectrophotometer at baseline (before treatment), 1 hour after the start of treatment, 1 week after, and 2 weeks after treatment |
| Secondary outcome measures | Periodontal health parameters, including Periodontal Pocket Depth (PPD), Clinical Attachment Level (CAL), Bleeding on Probing (BOP), and Gingival Recession (GR), were recorded using a UNC-15 periodontal probe at baseline, 4 weeks, 8 weeks, and 12 weeks. |
| Overall study start date | 13/11/2021 |
| Completion date | 23/08/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Individuals aged 18 to 25 years with anterior teeth crowding ranging from 3 to 6 mm 2. Maintaining excellent oral hygiene and periodontal health 3. Without prior orthodontic treatment history |
| Key exclusion criteria | 1. Systemic medical conditions 2. Dental anomalies in tooth size or shape 3. Current use of anti-inflammatory medications |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 01/01/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Lattakia
0000
Syria
Sponsor information
University/education
Lattakia
Latakia
0000
Syria
| Phone | +963 (0)41420291 |
|---|---|
| info@tishreen.edu.sy | |
| Website | http://en.tishreen.edu.sy/ |
"ROR" |
https://ror.org/04nqts970 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- October University, Université Tichrine, جامعة تشرين, TU
- Location
- Syria
Results and Publications
| Intention to publish date | 15/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available on request from Dr May Alel (akeelmai035@gmail.com) and in the publication related to it after the end of the research. |
Editorial Notes
30/08/2024: Study's existence confirmed by Tishreen University.
