Intrabony Periodontal DefectNCT05499598
Evaluation of Modified Minimally Invasive Surgical Technique and Platelet Rich Fibrin With or Without Vitamin Pool A and C for Management of Periodontal Intrabony Defects
A study testing Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C and Modified minimally invasive surgical technique with PRF in people with Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to assess clinical and radiographic outcomes after the use of vitamins A and C with PRF versus PRF alone in the treatment of periodontal intrabony defect. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C and Modified minimally invasive surgical technique with PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 May 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient-related criteria:
- Patient consulting in the outpatient clinic with periodontitis stage III
- Able to tolerate surgical periodontal procedures.
- Patient ready to perform oral hygiene instructions.
- Compliance with the maintenance program.
- Provide informed consent.
Show all 10Show fewer
- Accepts the 6 months follow-up period.
- Teeth related criteria:
- Mature permanent tooth.
- Tooth with two or three-walled intra-bony defect, with CAL ≥ 5mm and intra osseous defect ≥ 3mm.
Who cannot join
- Patient-related criteria:
- Medically compromised patients.
- Pregnant or nursing women.
- Uncooperative patients.
- Smokers.
- Teeth related criteria:
Show all 9Show fewer
- Teeth with one wall intra-bony defect.
- Teeth with supra-bony defects.
- Teeth with grade III mobility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Modified Minimally Invasive Surgical Technique and Platelet Rich Fibrin With or Without Vitamin Pool A and C for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial
This study aims to assess clinical and radiographic outcomes after the use of vitamins A and C with PRF versus PRF alone in the treatment of periodontal intrabony defect.
Read the detailed description
Sites with deep intrabony defects were considered to be at a higher risk of disease progression if patients did not receive any systematic periodontal therapy. Treatment of intrabony defects is an important therapeutic goal of periodontal therapy. The optimal outcome of treatment in intrabony defects is considered to be the absence of bleeding on probing, the presence of shallow pockets associated with periodontal regeneration and limited soft tissue recession.The minimally invasive surgical technique is designed to mobilize just the defect-associated papilla and to reduce flap extension as much as possible. The modified minimally invasive surgical technique has been proposed to further reduce invasiveness and patient side effects by limiting the incision line to the buccal side. This technique fulfilled the maintenance of the interdental papillary height by minimizing its tendency to collapse, increased the likelihood of primary wound closure and reduced the chances of gingival recession.
Platelet-rich fibrin is a powerful healing biomaterial with inherent regenerative capacity and can be used in the treatment of periodontal intrabony defects.
Vitamin C is found to be able to induce osteogenic differentiation and maturation of progenitor cells of PDL without using osteogenic filling material. Also, Vitamin A has a unique property of de-differentiating adult cells into pluripotent cells.
Since combination therapies have been shown to be effective in the regeneration of periodontal defects, this study will evaluate the synergetic effect of vitamins A and C on the periodontal regeneration, together with the most widely used regenerative biomaterial; Platelet-rich fibrin, as an attempt for finding the gold standard in the treatment of intra-bony defects.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C, Modified minimally invasive surgical technique with PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and CProcedure or surgery
Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. Ascorbic Acid will be added to the fresh blood to achieve a concentration of 250 μg/ml, Retinol will also be added to achieve a concentration of 20 μmol/L. The resultant PRF clot will be placed into the intra-osseous defect.
Modified minimally invasive surgical technique with PRFProcedure or surgery
Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. The resultant PRF clot will be placed into the intra-osseous defect.
| Study group | Role | What they receive |
|---|---|---|
| Modified minimally invasive surgical technique with PRF and vitamins A and C | Experimental | Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. Ascorbic Acid will be added to the fresh blood to achieve a concentration of 250 μg/ml, Retinol will also be added to achieve a concentration of 20 μmol/L. The resultant PRF clot will be placed into the intra-osseous defect. Receives: Procedure: Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C |
| Modified minimally invasive surgical technique with PRF | Active comparator | Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of whole blood is drawn by venipuncture of the antecubital vein and is collected into two blood collection tubes without anticoagulant for PRF preparation.The resultant PRF clot will be placed into the intra-osseous defect Receives: Procedure: Modified minimally invasive surgical technique with PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic linear defect depth (mm)
Digital Radiographs using ImageJ software, Measured as the depth of intra-osseous defect from the alveolar crest to the defect.
Measured: 9 months
Secondary outcomes (3)
Probing depth (mm)
Measured from the gingival margin to the bottom of the gingival sulcus
Measured: 9 months
Clinical Attachment Level (mm)
Measured from the CEJ to the bottom of the gingival sulcus
Measured: 9 months
Gingival Recession Depth (mm)
Measured from the CEJ to the most apical extension of the gingival margin
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Sanaa Abdel Ghaffar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499598
- Sponsor's protocol ID
- PERAUG2022
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2022
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Heitz-Mayfield LJ, Lang NP. Surgical and nonsurgical periodontal therapy. Learned and unlearned concepts. Periodontol 2000. 2013 Jun;62(1):218-31. doi: 10.1111/prd.12008.
PubMed 23574468Elbehwashy MT, Hosny MM, Elfana A, Nawar A, Fawzy El-Sayed K. Clinical and radiographic effects of ascorbic acid-augmented platelet-rich fibrin versus platelet-rich fibrin alone in intra-osseous defects of stage-III periodontitis patients: a randomized controlled clinical trial. Clin Oral Investig. 2021 Nov;25(11):6309-6319. doi: 10.1007/s00784-021-03929-1. Epub 2021 Apr 12.
PubMed 33842996Fawzy El-Sayed KM, Hein D, Dorfer CE. Retinol/inflammation affect stemness and differentiation potential of gingival stem/progenitor cells via Wnt/beta-catenin. J Periodontal Res. 2019 Aug;54(4):413-423. doi: 10.1111/jre.12643. Epub 2019 Mar 4.
PubMed 30830694Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.
PubMed 16504849Sanaa D, Elbattawy W, Hassan A, Magdeldin S, Mokhtar M, Abdelmoneim TK, Fawzy El-Sayed K. Vitamins A- and C-augmented platelet-rich fibrin in periodontal intraosseous defects: A randomized clinical trial. J Periodontol. 2026 Jul 29. doi: 10.1002/jper.70173. Online ahead of print.
PubMed 42522415
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Modified Minimally Invasive Surgical Technique and Platelet Rich Fibrin With or Without Vitamin Pool A and C for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05499598
- Acronym / sponsor ID
- PERAUG2022
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 12 Aug 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.
This study aims to assess clinical and radiographic outcomes after the use of vitamins A and C with PRF versus PRF alone in the treatment of periodontal intrabony defect.
Detailed description
Sites with deep intrabony defects were considered to be at a higher risk of disease progression if patients did not receive any systematic periodontal therapy. Treatment of intrabony defects is an important therapeutic goal of periodontal therapy. The optimal outcome of treatment in intrabony defects is considered to be the absence of bleeding on probing, the presence of shallow pockets associated with periodontal regeneration and limited soft tissue recession.The minimally invasive surgical technique is designed to mobilize just the defect-associated papilla and to reduce flap extension as much as possible. The modified minimally invasive surgical technique has been proposed to further reduce invasiveness and patient side effects by limiting the incision line to the buccal side. This technique fulfilled the maintenance of the interdental papillary height by minimizing its tendency to collapse, increased the likelihood of primary wound closure and reduced the chances of gingival recession.
Platelet-rich fibrin is a powerful healing biomaterial with inherent regenerative capacity and can be used in the treatment of periodontal intrabony defects.
Vitamin C is found to be able to induce osteogenic differentiation and maturation of progenitor cells of PDL without using osteogenic filling material. Also, Vitamin A has a unique property of de-differentiating adult cells into pluripotent cells.
Since combination therapies have been shown to be effective in the regeneration of periodontal defects, this study will evaluate the synergetic effect of vitamins A and C on the periodontal regeneration, together with the most widely used regenerative biomaterial; Platelet-rich fibrin, as an attempt for finding the gold standard in the treatment of intra-bony defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified minimally invasive surgical technique with PRF and vitamins A and C | Experimental | Procedure: Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and CSurgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. Ascorbic Acid will be added to the fresh blood to achieve a concentration of 250 μg/ml, Retinol will also be added to achieve a concentration of 20 μmol/L. The resultant PRF clot will be placed into the intra-osseous defect. |
| Modified minimally invasive surgical technique with PRF | Active comparator | Procedure: Modified minimally invasive surgical technique with PRFSurgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of whole blood is drawn by venipuncture of the antecubital vein and is collected into two blood collection tubes without anticoagulant for PRF preparation.The resultant PRF clot will be placed into the intra-osseous defect |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patient-related criteria:
- Mature permanent tooth.
- Tooth with two or three-walled intra-bony defect, with CAL ≥ 5mm and intra osseous defect ≥ 3mm.
Key exclusion criteria (9 listed)
- Patient-related criteria:
- Teeth with one wall intra-bony defect.
- Teeth with supra-bony defects.
- Teeth with grade III mobility.
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 |
|---|---|---|
| Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and CSurgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. Ascorbic Acid will be added to the fresh blood to achieve a concentration of 250 μg/ml, Retinol will also be added to achieve a concentration of 20 μmol/L. The resultant PRF clot will be placed into the intra-osseous defect. | Procedure or surgery | Modified minimally invasive surgical technique with PRF and vitamins A and C |
| Modified minimally invasive surgical technique with PRFSurgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. The resultant PRF clot will be placed into the intra-osseous defect. | Procedure or surgery | Modified minimally invasive surgical technique with PRF |
Primary outcome
Radiographic linear defect depth (mm)
Time frame: 9 months
Digital Radiographs using ImageJ software, Measured as the depth of intra-osseous defect from the alveolar crest to the defect.
3 secondary outcomes
Probing depth (mm)
Time frame: 9 months
Clinical Attachment Level (mm)
Time frame: 9 months
Gingival Recession Depth (mm)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 23574468Heitz-Mayfield LJ, Lang NP. Surgical and nonsurgical periodontal therapy. Learned and unlearned concepts. Periodontol 2000. 2013 Jun;62(1):218-31. doi: 10.1111/prd.12008.
- Background: PubMed 33842996Elbehwashy MT, Hosny MM, Elfana A, Nawar A, Fawzy El-Sayed K. Clinical and radiographic effects of ascorbic acid-augmented platelet-rich fibrin versus platelet-rich fibrin alone in intra-osseous defects of stage-III periodontitis patients: a randomized controlled clinical trial. Clin Oral Investig. 2021 Nov;25(11):6309-6319. doi: 10.1007/s00784-021-03929-1. Epub 2021 Apr 12.
- Background: PubMed 30830694Fawzy El-Sayed KM, Hein D, Dorfer CE. Retinol/inflammation affect stemness and differentiation potential of gingival stem/progenitor cells via Wnt/beta-catenin. J Periodontal Res. 2019 Aug;54(4):413-423. doi: 10.1111/jre.12643. Epub 2019 Mar 4.
- Background: PubMed 16504849Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.
- Derived from this study: PubMed 42522415Sanaa D, Elbattawy W, Hassan A, Magdeldin S, Mokhtar M, Abdelmoneim TK, Fawzy El-Sayed K. Vitamins A- and C-augmented platelet-rich fibrin in periodontal intraosseous defects: A randomized clinical trial. J Periodontol. 2026 Jul 29. doi: 10.1002/jper.70173. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Intrabony Periodontal Defect
Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
Recruiting
Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
Periodontitis, Intrabony Periodontal Defect
Not yet recruiting
Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
Periodontitis, Periodontitis Stage III
Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C and Modified minimally invasive surgical technique with PRF 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 22 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic linear defect depth (mm) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499598, which also lists 5 linked publications.
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 22 Apr 2026.