Intrabony Periodontal DefectEarly Phase 1NCT03766139
Regenerative Potential of Supercell Glue and Platelet Rich Fibrin Matrix
A Early Phase 1 study testing SUPERCELL GLUE and PRFM ALONE in people with Intrabony Periodontal Defect, run by KLE Society's Institute of Dental Sciences at 1 site in India.
Trial summary
Utilizing the osteogenic properties of both platelet rich fibrin matrix and peripheral blood mesenchymal stem cells for periodontal regeneration would be novel and may be advantageous than using Platelet rich fibrin matrix alone. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- SUPERCELL GLUE and PRFM ALONE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2018to Nov 2019
- Phase
- Early Phase 1
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients diagnosed with chronic periodontitis.
- Patients with mandibular infrabony pocket measuring ≥ 6mm with radiographic evidence of intrabony defect
Who cannot join
- Pregnant /lactating women
- Patients taking any drug known to affect the number and function of platelets in the past 3 months.
- Patients with abnormal platelet count.
- Patients with immunologic diseases
- Current smokers.
- History of periodontal therapy in the last 6 months.
- Any other contraindications for periodontal surgery.
- Maxillary intrabony defect.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Kle Society'S Institute of Dental Sciences
Bangalore, Karnataka, 560022
LAVEENA SINGHAL, MDS, 9900330579, laveenasinghal13@gmail.com
SREEPARVATHY R, MDS, 8050377024, nairsreeparvathy61@gmail.com
About this study
Official title: Evaluation of Supercell Glue (Platelet Rich Fibrin Matrix{PRFM} AND Peripheral Blood Mesenchymal Stem Cells {PBMSCs} ) as a Regenerative Material in Human Mandibular Periodontal Intraosseous Defect - A Split Mouth Randomized Controlled Trial
Utilizing the osteogenic properties of both platelet rich fibrin matrix and peripheral blood mesenchymal stem cells for periodontal regeneration would be novel and may be advantageous than using Platelet rich fibrin matrix alone. The literature search does not show any human clinical trial conducted till date to assess the regenerative potential of this new material i.e. Supercell glue (PRFM and PBMSCs).In this new material because of the addition of a patented gel the second spin to procure the PRFM has been eliminated and this seems to be an additional advantage. This study therefore aims at the evaluation of Supercell glue (PRFM and PBMSCs) as a regenerative material in comparison with PRFM alone in human mandibular periodontal intraosseous defects.
Read the detailed description
Periodontal regeneration involves the formation of alveolar bone, cementum and a new functional periodontal ligament. Over the recent years the concept of periodontal treatment has focused towards regeneration with a goal of regaining natural periodontal apparatus. Numerous procedures have been investigated in the past to try to promote periodontal regeneration which range from root biomodifications, soft tissue grafts, bone replacement grafts, guided tissue regeneration to the use of combinations of the same. However the success of these approaches are highly variable. As a consequence current research trends are inclined towards the principle of 'biological solutions for biological problem' and thus attempts are directed towards various approaches like tissue engineering, ERT (endogenous regenerative technology), application of biologics, cell based techniques, biomimetic nanoscaffold fabrication and others for periodontal regeneration. Of all known Polypeptide Growth Factors, Platelet Derived Growth Factor (PDGF) and Transforming Growth Factor β (TGF β) which are abundant in α granule of platelets are shown to exert a favourable effect on periodontal regeneration. Therefore use of platelet concentrates is a convenient approach to obtain autologous growth factors.
Platelet rich fibrin matrix (PRFM) is an autologous concentrated platelet-rich thrombin free fibrin matrix, prepared by two step centrifugation of blood. Platelets isolated, remain intact and retain their growth factor compliment. This allows a more effective, sustained release of growth factors to the wound site following PRFM application. During the second spin, a cross-linking of fibrin takes place, resulting in the formation of a dense fibrin matrix, within which a concentration of viable platelets can be found. Having an organized fibrin matrix at the start of healing accelerates the speed of vascular ingress into the wound compared to non-accelerated healing, which requires a longer time for fibrin formation and the development of vascularity. The earlier the vascularity is established, faster is the migration of the bone-forming cells at the wound site and initiation of bone formation. Therapeutic applications of platelet-rich products have led to improved bone regeneration.
Mesenchymal stem cells (MSCs) are a multipotent stromal cells with prominent regenerative functions. MSCs were first identified and isolated from bone marrow and then found in various tissues including umbilical cord, adipose tissue and peripheral blood. Among these sources peripheral blood MSCs draw increasing attention as they share similar biological characteristics with MSCs derived from bone marrow or adipose tissue. Bone marrow derived mesenchymal stem cells(BMMSCs) are multipotent cells capable of differentiating into osteoblasts, chondrocytes, adipocytes, fibroblasts, tenocytes, and myoblasts, which are considered as a cell source for various tissue repair and regenerating bone defects. The requirements of aspiration of bone marrow from the patient will cause pain and morbidity of the donor sites. It will be very convenient if peripheral blood mesenchymal stem cells (PBMSCs) could be harvested and expanded to enough numbers, with their osteogenic capacity maintained in a clinical permitted period.
Hence, utilizing the osteogenic properties of both platelet rich fibrin matrix and peripheral blood mesenchymal stem cells for periodontal regeneration would be novel and may be advantageous than using Platelet rich fibrin matrix alone. The literature search does not show any human clinical trial conducted till date to assess the regenerative potential of this new material i.e. Supercell glue (PRFM and PBMSCs).In this new material because of the addition of a patented gel the second spin to procure the PRFM has been eliminated and this seems to be an additional advantage. This study therefore aims at the evaluation of Supercell glue (PRFM and PBMSCs) as a regenerative material in comparison with PRFM alone in human mandibular periodontal intraosseous defects.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- SUPERCELL GLUE, PRFM ALONE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPERCELL GLUEBiological
Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with supercell glue in test sites (randomly selected by computer generated tabulation method)
PRFM ALONEBiological
Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with PRFM in control sites(randomly selected by computer generated tabulation method)
| Study group | Role | What they receive |
|---|---|---|
| SUPERCELL GLUE(STEM CELLS AND PRFM) | Experimental | Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with supercell glue in test sites . Receives: Biological: SUPERCELL GLUE |
| PRFM ALONE | Active comparator | Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with PRFM in control sites Receives: Biological: PRFM ALONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early wound healing index (Supercell in early wound healing index)
early wound healing index in intraosseous periodontal defects
Measured: 1 week
Change in probing pocket depth and clinical attachment gain (Supercell as a regenerative novel material)
Change in probing pocket depth reduction and clinical attachment gain measured in millimetres in intraosseous defects
Measured: baseline,3 months,6 months
Change in the bone level (Supercell as a biological material)
change in the bone level will be assessed radiographically using Image J analysis software measured in millimeters
Measured: baseline, 3 months,6 months
Change in the clinical parameters of gingival index and plaque index (Supercell as a regenerative material using clinical indices)
change in the clinical parameters of gingival index and plaque index (no units as these are indices) in intraosseous periodontal defects
Measured: baseline,3 months,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study startDec 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionNov 2019 (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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a Double Blinded Randomized controlled clinical trial with a split mouth design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KLE Society's Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Laveena Singhal, KLE Society's Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766139
- Sponsor's protocol ID
- PARVATHY61
- Status last verified
- Dec 2018
- First submitted
- 13 Aug 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Supercell Glue (Platelet Rich Fibrin Matrix{PRFM} AND Peripheral Blood Mesenchymal Stem Cells {PBMSCs} ) as a Regenerative Material in Human Mandibular Periodontal Intraosseous Defect - A Split Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03766139
- Acronym / sponsor ID
- PARVATHY61
- Conditions
- Intrabony Periodontal Defect
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- KLE Society's Institute of Dental SciencesUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 6 Dec 2018 (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.
Utilizing the osteogenic properties of both platelet rich fibrin matrix and peripheral blood mesenchymal stem cells for periodontal regeneration would be novel and may be advantageous than using Platelet rich fibrin matrix alone. The literature search does not show any human clinical trial conducted till date to assess the regenerative potential of this new material i.e. Supercell glue (PRFM and PBMSCs).In this new material because of the addition of a patented gel the second spin to procure the PRFM has been eliminated and this seems to be an additional advantage. This study therefore aims at the evaluation of Supercell glue (PRFM and PBMSCs) as a regenerative material in comparison with PRFM alone in human mandibular periodontal intraosseous defects.
Detailed description
Periodontal regeneration involves the formation of alveolar bone, cementum and a new functional periodontal ligament. Over the recent years the concept of periodontal treatment has focused towards regeneration with a goal of regaining natural periodontal apparatus. Numerous procedures have been investigated in the past to try to promote periodontal regeneration which range from root biomodifications, soft tissue grafts, bone replacement grafts, guided tissue regeneration to the use of combinations of the same. However the success of these approaches are highly variable. As a consequence current research trends are inclined towards the principle of 'biological solutions for biological problem' and thus attempts are directed towards various approaches like tissue engineering, ERT (endogenous regenerative technology), application of biologics, cell based techniques, biomimetic nanoscaffold fabrication and others for periodontal regeneration. Of all known Polypeptide Growth Factors, Platelet Derived Growth Factor (PDGF) and Transforming Growth Factor β (TGF β) which are abundant in α granule of platelets are shown to exert a favourable effect on periodontal regeneration. Therefore use of platelet concentrates is a convenient approach to obtain autologous growth factors.
Platelet rich fibrin matrix (PRFM) is an autologous concentrated platelet-rich thrombin free fibrin matrix, prepared by two step centrifugation of blood. Platelets isolated, remain intact and retain their growth factor compliment. This allows a more effective, sustained release of growth factors to the wound site following PRFM application. During the second spin, a cross-linking of fibrin takes place, resulting in the formation of a dense fibrin matrix, within which a concentration of viable platelets can be found. Having an organized fibrin matrix at the start of healing accelerates the speed of vascular ingress into the wound compared to non-accelerated healing, which requires a longer time for fibrin formation and the development of vascularity. The earlier the vascularity is established, faster is the migration of the bone-forming cells at the wound site and initiation of bone formation. Therapeutic applications of platelet-rich products have led to improved bone regeneration.
Mesenchymal stem cells (MSCs) are a multipotent stromal cells with prominent regenerative functions. MSCs were first identified and isolated from bone marrow and then found in various tissues including umbilical cord, adipose tissue and peripheral blood. Among these sources peripheral blood MSCs draw increasing attention as they share similar biological characteristics with MSCs derived from bone marrow or adipose tissue. Bone marrow derived mesenchymal stem cells(BMMSCs) are multipotent cells capable of differentiating into osteoblasts, chondrocytes, adipocytes, fibroblasts, tenocytes, and myoblasts, which are considered as a cell source for various tissue repair and regenerating bone defects. The requirements of aspiration of bone marrow from the patient will cause pain and morbidity of the donor sites. It will be very convenient if peripheral blood mesenchymal stem cells (PBMSCs) could be harvested and expanded to enough numbers, with their osteogenic capacity maintained in a clinical permitted period.
Hence, utilizing the osteogenic properties of both platelet rich fibrin matrix and peripheral blood mesenchymal stem cells for periodontal regeneration would be novel and may be advantageous than using Platelet rich fibrin matrix alone. The literature search does not show any human clinical trial conducted till date to assess the regenerative potential of this new material i.e. Supercell glue (PRFM and PBMSCs).In this new material because of the addition of a patented gel the second spin to procure the PRFM has been eliminated and this seems to be an additional advantage. This study therefore aims at the evaluation of Supercell glue (PRFM and PBMSCs) as a regenerative material in comparison with PRFM alone in human mandibular periodontal intraosseous defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study will be a Double Blinded Randomized controlled clinical trial with a split mouth design.
| Arm | Type | Receives |
|---|---|---|
| SUPERCELL GLUE(STEM CELLS AND PRFM) | Experimental | Biological: SUPERCELL GLUEFollowing optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with supercell glue in test sites . |
| PRFM ALONE | Active comparator | Biological: PRFM ALONEFollowing optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with PRFM in control sites |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Systemically healthy patients diagnosed with chronic periodontitis.
- Patients with mandibular infrabony pocket measuring ≥ 6mm with radiographic evidence of intrabony defect
Key exclusion criteria (8 listed)
- Pregnant /lactating women
- Patients taking any drug known to affect the number and function of platelets in the past 3 months.
- Patients with abnormal platelet count.
- Patients with immunologic diseases
- Current smokers.
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 |
|---|---|---|
| SUPERCELL GLUEFollowing optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with supercell glue in test sites (randomly selected by computer generated tabulation method) | Biological | SUPERCELL GLUE(STEM CELLS AND PRFM) |
| PRFM ALONEFollowing optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with PRFM in control sites(randomly selected by computer generated tabulation method) | Biological | PRFM ALONE |
Primary outcome
Early wound healing index (Supercell in early wound healing index)
Time frame: 1 week
early wound healing index in intraosseous periodontal defects
Change in probing pocket depth and clinical attachment gain (Supercell as a regenerative novel material)
Time frame: baseline,3 months,6 months
Change in probing pocket depth reduction and clinical attachment gain measured in millimetres in intraosseous defects
Change in the bone level (Supercell as a biological material)
Time frame: baseline, 3 months,6 months
change in the bone level will be assessed radiographically using Image J analysis software measured in millimeters
Change in the clinical parameters of gingival index and plaque index (Supercell as a regenerative material using clinical indices)
Time frame: baseline,3 months,6 months
change in the clinical parameters of gingival index and plaque index (no units as these are indices) in intraosseous periodontal defects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SUPERCELL GLUE and PRFM ALONE in people with Intrabony Periodontal Defect, run by KLE Society's Institute of Dental Sciences at 1 site in India.
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 2 inclusion and 8 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 7 Dec 2018. 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 India. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early wound healing index (Supercell in early wound healing index) (time frame: 1 week). The study lists 4 primary outcomes in all. 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 7 Dec 2018.