Intrabony Periodontal DefectNCT05285293
Periodontal Regeneration Using Vitamin A and PRF Compared to PRF Alone Treating Intra-bony Defects
A study testing Platelet Rich Fibrin (PRF) and Platelet Rich Fibrin (PRF) and Retinol in people with Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.
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? Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Platelet Rich Fibrin (PRF) and Platelet Rich Fibrin (PRF) and Retinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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?
Read the 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.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Platelet Rich Fibrin (PRF), Platelet Rich Fibrin (PRF) and Retinol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Fibrin (PRF)Biological
Platelet rich fibrin (PRF) in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)
Platelet Rich Fibrin (PRF) and RetinolBiological
Platelet rich fibrin (PRF) mixed with Retinol in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Control | Active comparator | PRF in intra-bony defects Receives: Biological: Platelet Rich Fibrin (PRF) |
| Group 2 Experimental | Experimental | PRF and Retinol in intra-bony defects Receives: Biological: Platelet Rich Fibrin (PRF) and Retinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic linear defect depth
Measured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004)
Measured: 6 Month
Secondary outcomes (3)
Clinical attachment level
clinical attachment level measured in mm. using williams graduated probe(SP, 1967)
Measured: 6 Month
Probing pocket depth
Measuring probing depth in mm using William's graduated Periodontal probe (SP, 1967)
Measured: 6 Month
Radiographic defect bone density
Bone density will be measured using Digital Radiographs using ImageJ software (B et al., 2019)
Measured: 6 MOnth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Hassan Mostafa, Cairo University
- Investigators
- Abdallah H. Mostafa, M.Sc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285293
- Sponsor's protocol ID
- 121221
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Inclusion, exclusion criteria, Methodology and Results
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05285293
- Acronym / sponsor ID
- 121221
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Control | Active comparator | Biological: Platelet Rich Fibrin (PRF)PRF in intra-bony defects |
| Group 2 Experimental | Experimental | Biological: Platelet Rich Fibrin (PRF) and RetinolPRF and Retinol in intra-bony defects |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich Fibrin (PRF)Platelet rich fibrin (PRF) in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST) | Biological | Group 1 Control |
| Platelet Rich Fibrin (PRF) and RetinolPlatelet rich fibrin (PRF) mixed with Retinol in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST) | Biological | Group 2 Experimental |
Primary outcome
Radiographic linear defect depth
Time frame: 6 Month
Measured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004)
3 secondary outcomes
Clinical attachment level
Time frame: 6 Month
Probing pocket depth
Time frame: 6 Month
Radiographic defect bone density
Time frame: 6 MOnth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Yes. Inclusion, exclusion criteria, Methodology and Results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdallah H. Mostafa, M.Sc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Fibrin (PRF) and Platelet Rich Fibrin (PRF) and Retinol in people with Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdallah H. Mostafa, M.Sc. (+2001005682509, dr.abdallah.hassan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic linear defect depth (time frame: 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.