Periodontal Regeneration Using Vitamin A and PRF Compared to PRF Alone Treating Intra-bony Defects

Intrabony Periodontal Defect Clinical Trial

Official title:

Clinical Evaluation of Periodontal Regeneration Using Vitamin A Added to PRF in Comparison to PRF Alone in Treatment of Intra-bony Defects: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05285293
• Other study ID #: 121221
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: Abdallah H. Mostafa, M.Sc.
• Phone: +2001005682509
• Email: dr.abdallah.hassan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Will the addition of vitamin A (Retinol) to PRF add more periodontal regenerative value in the treatment of intra-bony defects compared to PRF alone, clinically?

Description:

Vitamin A has been extensively studied for its role in bone health. Vitamin A can be consumed in two forms, i.e., preformed retinol and pro-vitamin A. Preformed retinol is often found in food originated from animals, such as dairy, liver and eggs. Provitamin A, such as alpha (α)-carotene, beta (β)-carotene orβ-cryptoxanthin, are commonly found in plant-based food, such as fruits and vegetables (Toti et al., 2018). At certain concentrations, it has been proven to enhance the pluripotency of periodontal cells for regeneration (Fawzy El-Sayed, Hein and Dörfer, 2019). Yet, to the best of our knowledge no clinical trials have evaluated the effect of Vitamin A added to PRF in the regeneration of intra-bony defects. This study is to fill the gap of knowledge.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Stage III periodontitis patient (Papapanou et al., 2018) with 3 walled or 2 walled intra-bony defects.
• Non-smokers
• No pregnancy
• Medically free
• Presence of intra-bony defect of three or two walls (as predominant component) with a radiographic intra-bony component of =3 mm;
• Presence of =2 mm of keratinized gingiva at the tooth with the defect.
• Willingness to optimal compliance with the study procedures

Exclusion Criteria:

• Uncontrolled systemic or local infection in the tissue of interest,
• History or clinical evidence or positive tests for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV).
• History of chronic autoimmune disease
• Participation in an intervention trial in the same quadrant in the previous two months.
• Type III tooth mobility, vertical root fracture in the selected tooth.
• Contraindications for periodontal surgery.

Related Conditions & MeSH terms

• Intrabony Periodontal Defect

Intervention

Biological:
• Platelet Rich Fibrin (PRF)
Platelet rich fibrin (PRF) in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)
• Platelet Rich Fibrin (PRF) and Retinol
Platelet rich fibrin (PRF) mixed with Retinol in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic linear defect depth	Measured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004)	6 Month
Secondary	Clinical attachment level	clinical attachment level measured in mm. using williams graduated probe(SP, 1967)	6 Month
Secondary	Probing pocket depth	Measuring probing depth in mm using William's graduated Periodontal probe (SP, 1967)	6 Month
Secondary	Radiographic defect bone density	Bone density will be measured using Digital Radiographs using ImageJ software (B et al., 2019)	6 MOnth