Periodontal Health Clinical Trial
Official title:
Evaluation of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on the Periodontal Health During Canine Distalization: A Randomized Controlled Clinical Trial
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.
Status | Recruiting |
Enrollment | 14 |
Est. completion date | April 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion criteria: 1. Age: 18- 40 years old. 2. Angle Class I or Class II dental malocclusion that required bilateral maxillary first premolar extraction and upper canine retraction as a part of the treatment plan. 3. Good to fair oral hygiene. 4. Normal probing depth. Exclusion criteria: 1. Active periodontal disease. 2. Poor oral hygiene. 3. Systemic diseases or medications that alter bone metabolism or tooth movement. 4. Craniofacial anomalies. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry Beni Suef University | Bani Suwayf |
Lead Sponsor | Collaborator |
---|---|
Beni-Suef University |
Egypt,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evaluate the effect of using PRF and Vitamin D? 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 | |
Other | Evaluate the effect of using PRF and Vitamin D? 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. Mild inflammation, slight color change, mild alteration of gingival surface, no bleeding. Moderate inflammation, erythema, swelling, bleeding on probing or when pressure is applied severe inflammation, severe erythema, swelling, tendency towards spontaneous bleeding some ulceration. |
3 - 4 months | |
Other | Evaluate the effect of using PRF and Vitamin D? injections on the plaque index. | Plaque index will be evaluated by the following scores before and after canine retraction:
0: No dental plaque Thin film of plaque at the gingival margin not visible by naked eye and detect by probe Moderate film of plaque at the gingival margin, interdental space free of plaque visible by naked eye Heavy plaque accumulation at the gingival margin on interdental space filled with plaque (calculus) |
3 - 4 months | |
Other | Evaluate the effect of using PRF and Vitamin D? 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 | |
Primary | Evaluate the effect of using PRF and Vitamin D? 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 | |
Secondary | Investigate the effect of PRF and Vitamin D? 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 |
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