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The study aims to evaluate the effect of using PRF and vitamin Dꝫ injections on periodontal health and parameters and compare them when used to facilitate orthodontic treatment.
Group 1 (PRF group): upper canine retraction will be facilitated by PRF injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.
Group II (Vitamin Dꝫ group): canine retraction will be facilitated by Vitamin Dꝫ injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.
Methodology:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich Fibrin | Experimental | A 20 ml blood sample will be drawn from the median cubital vein into a PRF tube. Centrifugation will be done at 700 rpm for 3 minutes and the liquid of PRF will be suctioned out using a separate syringe. PRF will be injected distal to the canine on the experimental side three times; at the beginning of canine retraction (T0), 1 month after the start of canine retraction (T1), and 2 months after the start of canine retraction (T2). |
|
| Vitamin D3 | Experimental | Subjects will receive vitamin Dꝫ injection distal to the canine on the experimental side three times; at the beginning of canine retraction (T0), 1 month after the start of canine retraction (T1), and 2 months after the start of canine retraction (T2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-rich Fibrin | Other | PRF will be injected distal to the canine on the experimental side. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on periodontal health and compare them. | Clinical periodontal examination of the upper canines will be done before and after retraction on the experimental and control sides by recording the probing depth (PD). • The probing depth will be measured from the gingival margin to the base of the gingival sulcus in millimeters by using a manual periodontal probe (William's probe). The measurements will be recorded at 6 sites around the tooth. | 3 - 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the effect of PRF and Vitamin Dꝫ injections on the gingival thickness. | The gingival thickness will be recorded using an endodontic file with a stopper, which is placed horizontally, perpendicular to the long axis of the tooth on the labial gingiva. | 3 - 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on the width of keratinized mucosa (KM) | The width of keratinized mucosa (KM) on the facial aspect will be measured in millimeters at the mid-facial aspects from the mucogingival junction to the free gingival margin using a periodontal probe before and after canine retraction. | 3 - 4 months |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rehab Khalil | Contact | 01005230669 | rehababdelrazek@dent.bsu.edu.eg | |
| Maha Abdelkawy | Contact | 01005276754 | maha_abdelkawy@dent.bsu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Rehab Khalil | Faculty of Dentistry Beni Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Beni Suef University | Recruiting | Banī Suwayf | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36008239 | Background | Gupta P, Bhagyalakshmi A, Avinash BS, Prashant A, Raghunath N. Evaluation of injectable platelet-rich fibrin effect on the rate of canine retraction and alkaline phosphatase levels: An in-vivo study. Am J Orthod Dentofacial Orthop. 2022 Nov;162(5):735-743. doi: 10.1016/j.ajodo.2021.07.019. Epub 2022 Aug 23. | |
| 33962809 | Background |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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split-mouth, prospective, single-center, single-blinded, two-arm randomized clinical trial with a 1:1 allocation ratio.
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Single-blinded limited to the outcome assessment
| Vitamin D3 | Other | Vitamin Dꝫ will be injected distal to the canine on the experimental side |
|
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on the gingival index. |
The gingival index will be evaluated by the following scores before and after canine retraction: 0: Normal gingival, no inflammation, no discoloration, no bleeding.
|
| 3 - 4 months |
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on the plaque index. | Plaque index will be evaluated by the following scores before and after canine retraction: 0: No dental plaque
| 3 - 4 months |
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on the clinical attachment level (CAL) | Clinical attachment level (CAL) will be measured from the cementoenamel junction to the base of the periodontal pocket in millimeters by using a periodontal probe. | 3 - 4 months |
| Cagli Karci I, Baka ZM. Assessment of the effects of local platelet-rich fibrin injection and piezocision on orthodontic tooth movement during canine distalization. Am J Orthod Dentofacial Orthop. 2021 Jul;160(1):29-40. doi: 10.1016/j.ajodo.2020.03.029. Epub 2021 May 4. |
| 33481053 | Background | Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22. |
| 32381845 | Background | Varughese ST, Shamanna PU, Goyal N, Thomas BS, Lakshmanan L, Pulikkottil VJ, Ahmed MG. Effect of Vitamin D on Canine Distalization and Alveolar Bone Density Using Multi-slice Spiral CT: A Randomized Controlled Trial. J Contemp Dent Pract. 2019 Dec 1;20(12):1430-1435. |
| 18385025 | Background | Bollen AM, Cunha-Cruz J, Bakko DW, Huang GJ, Hujoel PP. The effects of orthodontic therapy on periodontal health: a systematic review of controlled evidence. J Am Dent Assoc. 2008 Apr;139(4):413-22. doi: 10.14219/jada.archive.2008.0184. |
| 35607316 | Background | Faour NH, Dayoub S, Hajeer MY. Evaluation of the Hyaluronic Acid Versus the Injectable Platelet-Rich Fibrin in the Management of the Thin Gingival Phenotype: A Split-Mouth Randomized Controlled Clinical Trial. Cureus. 2022 May 18;14(5):e25104. doi: 10.7759/cureus.25104. eCollection 2022 May. |
| 33653326 | Background | Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9. |
| 36537578 | Background | Lu EM. The role of vitamin D in periodontal health and disease. J Periodontal Res. 2023 Apr;58(2):213-224. doi: 10.1111/jre.13083. Epub 2022 Dec 20. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |