Regenerative Potential of Supercell Glue and Platelet Rich Fibrin Matrix

NCT03766139 | Unknown Early Phase 1 DMC

• 1 other identifier: PARVATHY61
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• Early wound healing index (Supercell in early wound healing index)

  early wound healing index in intraosseous periodontal defects

  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

  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

  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

  baseline,3 months,6 months

Study Arms (2)

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 .

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

Biological: PRFM ALONE

Interventions

SUPERCELL GLUE BIOLOGICAL

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)

SUPERCELL GLUE(STEM CELLS AND PRFM)

PRFM ALONE BIOLOGICAL

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)

PRFM ALONE

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patients diagnosed with chronic periodontitis.
• Patients with mandibular infrabony pocket measuring ≥ 6mm with radiographic evidence of intrabony defect

You may not qualify if:

• 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.

Sponsors & Collaborators

• KLE Society's Institute of Dental Sciences: lead

Study Sites (1)

Kle Society'S Institute of Dental Sciences

Bangalore, Karnataka, 560022, India

RECRUITING

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The sites will be randomly (computer generated tabulation method) assigned into control group (treated with PRFM alone) and test group (treated with Supercell Glue).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study will be a Double Blinded Randomized controlled clinical trial with a split mouth design.

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: December 6, 2018
• Study Start: December 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

IN (1)