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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05285293
Collaborator
(none)
28
1
2
18
1.6

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Biological: Platelet Rich Fibrin (PRF)
  • Biological: Platelet Rich Fibrin (PRF) and Retinol
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1 Control

PRF in intra-bony defects

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

Experimental: Group 2 Experimental

PRF and Retinol in intra-bony defects

Biological: 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)

Outcome Measures

Primary Outcome Measures

  1. Radiographic linear defect depth [6 Month]

    Measured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004)

Secondary Outcome Measures

  1. Clinical attachment level [6 Month]

    clinical attachment level measured in mm. using williams graduated probe(SP, 1967)

  2. Probing pocket depth [6 Month]

    Measuring probing depth in mm using William's graduated Periodontal probe (SP, 1967)

  3. Radiographic defect bone density [6 MOnth]

    Bone density will be measured using Digital Radiographs using ImageJ software (B et al., 2019)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo University Cairo Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Abdallah H. Mostafa, M.Sc, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abdallah Hassan Mostafa, B.Sc., M.Sc. Abdallah Hassan Mostafa, Cairo University
ClinicalTrials.gov Identifier:
NCT05285293
Other Study ID Numbers:
  • 121221
First Posted:
Mar 17, 2022
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2022