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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05285293
Enrollment
28
Registered
2022-03-17
Start date
2022-06-01
Completion date
2023-12-01
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrabony Periodontal Defect

Brief 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?

Detailed 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.

Interventions

Platelet rich fibrin (PRF) in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)

BIOLOGICALPlatelet 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)

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic linear defect depth6 MonthMeasured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004)

Secondary

MeasureTime frameDescription
Clinical attachment level6 Monthclinical attachment level measured in mm. using williams graduated probe(SP, 1967)
Probing pocket depth6 MonthMeasuring probing depth in mm using William's graduated Periodontal probe (SP, 1967)
Radiographic defect bone density6 MOnthBone density will be measured using Digital Radiographs using ImageJ software (B et al., 2019)

Countries

Egypt

Contacts

Primary ContactAbdallah H. Mostafa, M.Sc.
dr.abdallah.hassan@gmail.com+2001005682509

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026