Injectable Platelet Rich Fibrin and Microneedling in Papilla ReconstructionPhase 2iPRFandMNNCT06021301
Injectable Platelet-Rich Fibrin and Microneedling For Papillae Reconstruction In Esthetic Zone
A Phase 2 study testing Platelet-Rich Fibrin and Microneedling in people with Injectable Platelet Rich Fibrin and Microneedling in Papilla Reconstruction and Interdental Papillae Reconstruction, run by Cairo University at 1 site in Egypt.
Trial summary
The currently available non-surgical techniques for papillary reconstruction did not provide long term maintenance of papillary regeneration, Surgical techniques are invasive and the results are unpredictable . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Injectable Platelet Rich Fibrin and Microneedling in Papilla Reconstruction, Interdental Papillae Reconstruction
- What is being tested?
- Platelet-Rich Fibrin and Microneedling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2023to Jun 2024
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nonsmoking patients aged above 18 years.
- At least one site with interdental papilla recession in the anterior region of the maxillary or mandibular jaws.
- The distance from the contact point to alveolar bone is crest < 7 mm.
- Class I or Class II papillary recession, according to Nordland and Tarnow's classification systems (Nordland et al., 1998).
- No active periodontal diseases and good oral hygiene.
Who cannot join
- Patients were excluded from the study if they have:
- Spacing or crowding between the teeth to be treated
- Abnormal tooth shape
- Systemic diseases such as diabetes mellitus, hypertension or conditions that alter the outcome of periodontal therapy.
- In addition, patients will be excluded if they are Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry ,Cairo University
Cairo
yasmeen saleh, Resident, 01027453609, yasmeen.tolba@dentistry.cu.edu.egyas
About this study
Official title: Injectable Platelet-Rich Fibrin and Microneedling For Papillae Reconstruction In Esthetic Zone (A Case Series )
The currently available non-surgical techniques for papillary reconstruction did not provide long term maintenance of papillary regeneration, Surgical techniques are invasive and the results are unpredictable . The study is based upon the positive effects of iPRF upon enhancing wound healing in terms of new collagen formation, angiogenesis and increasing keratinized tissue phenotype . iPRF exhibited comparable effects to subepithelial connective tissue graft in papillary reconstruction . The effect of microneedling on the tissue responds as if experiencing tissue trauma and the body's own collagen production is induced to preserve tissue integrity . Growth factors are released immediately after injury, inducing the proliferation of new cells, and fibroblasts are transformed into collagen and elastin fibres from day 5 up to week 8 .
Read the detailed description
The patients diagnosed with black triangles according to Norland classification system for loss of papillary height will be selected. Each patient will receive a proper knowledge of the study protocols along with full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments and will be given personalized oral hygiene instructions. After oral prophylaxis and baseline measurements of insufficient interdental papilla the treatment will be MN and iPRF. First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm. Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively. The final clinical photographs and measurements will recorded 3 and 6 months of last dose administered . After the intervention, patients will receive oral hygiene instructions that include the roll technique when brushing without the use of floss and toothpick during the study period to minimize trauma to the treated site .
- Conditions
- Injectable Platelet Rich Fibrin and Microneedling in Papilla Reconstruction, Interdental Papillae Reconstruction
- Being tested
- Platelet-Rich Fibrin and Microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Fibrin and MicroneedlingOther
First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively.
| Study group | Role | What they receive |
|---|---|---|
| iPRF and Microneedling | Experimental | First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively. Receives: Other: Platelet-Rich Fibrin and Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Papillary height
using UNC probe from papillary tip till incisal edge.
Measured: at 3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study startNov 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injectable Platelet Rich Fibrin and Microneedling in Papilla ReconstructionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case Series
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmeen Saleh Tolba, Cairo University
- Investigators
- yasmeen tolba, Resident, Principal investigator, department of periodontology ,cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021301
- Sponsor's protocol ID
- P E R 3-3-1
- Acronym
- iPRFandMN
- Status last verified
- Nov 2023
- First submitted
- 27 Aug 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Platelet-Rich Fibrin and Microneedling For Papillae Reconstruction In Esthetic Zone (A Case Series )
- ClinicalTrials.gov ID
- NCT06021301
- Acronym / sponsor ID
- iPRFandMN / P E R 3-3-1
- Conditions
- Injectable Platelet Rich Fibrin and Microneedling in Papilla Reconstruction, Interdental Papillae Reconstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 1 Sep 2023 (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.
The currently available non-surgical techniques for papillary reconstruction did not provide long term maintenance of papillary regeneration, Surgical techniques are invasive and the results are unpredictable . The study is based upon the positive effects of iPRF upon enhancing wound healing in terms of new collagen formation, angiogenesis and increasing keratinized tissue phenotype . iPRF exhibited comparable effects to subepithelial connective tissue graft in papillary reconstruction . The effect of microneedling on the tissue responds as if experiencing tissue trauma and the body's own collagen production is induced to preserve tissue integrity . Growth factors are released immediately after injury, inducing the proliferation of new cells, and fibroblasts are transformed into collagen and elastin fibres from day 5 up to week 8 .
Detailed description
The patients diagnosed with black triangles according to Norland classification system for loss of papillary height will be selected. Each patient will receive a proper knowledge of the study protocols along with full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments and will be given personalized oral hygiene instructions. After oral prophylaxis and baseline measurements of insufficient interdental papilla the treatment will be MN and iPRF. First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm. Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively. The final clinical photographs and measurements will recorded 3 and 6 months of last dose administered . After the intervention, patients will receive oral hygiene instructions that include the roll technique when brushing without the use of floss and toothpick during the study period to minimize trauma to the treated site .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case Series
| Arm | Type | Receives |
|---|---|---|
| iPRF and Microneedling | Experimental | Other: Platelet-Rich Fibrin and MicroneedlingFirst, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Nonsmoking patients aged above 18 years.
- At least one site with interdental papilla recession in the anterior region of the maxillary or mandibular jaws.
- The distance from the contact point to alveolar bone is crest < 7 mm.
- Class I or Class II papillary recession, according to Nordland and Tarnow's classification systems (Nordland et al., 1998).
- No active periodontal diseases and good oral hygiene.
Key exclusion criteria (5 listed)
- Patients were excluded from the study if they have:
- Spacing or crowding between the teeth to be treated
- Abnormal tooth shape
- Systemic diseases such as diabetes mellitus, hypertension or conditions that alter the outcome of periodontal therapy.
- In addition, patients will be excluded if they are Pregnant and lactating women.
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 and MicroneedlingFirst, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively. | Other | iPRF and Microneedling |
Primary outcome
Papillary height
Time frame: at 3,6 months
using UNC probe from papillary tip till incisal edge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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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.
yasmeen tolba, Resident principal investigator
department of periodontology ,cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet-Rich Fibrin and Microneedling in people with Injectable Platelet Rich Fibrin and Microneedling in Papilla Reconstruction and Interdental Papillae Reconstruction, 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 5 inclusion and 5 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 8 Nov 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 yasmeen tolba, Resident (01027453609, yasmeen.tolba@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Papillary height (time frame: at 3,6 months). 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 8 Nov 2023.