Effect on Allogenic Mesenchymal Stem Cells on Osseointegration of Dental Implants
Effect on Allogenic Mesenchymal Stem Cells on Osseointegration of Dental Implants
As Regenerative Medicine is the next level in medicinal sciences, the use of mesenchymal
 cells have become prevalent, Similarly now stem cells are being used in dental research as
 well in various clinical applications.This study aims to evaluate the overall effect of
 osseointegration by use of Allogenic Mesenchymal Stem cells while placing dental
 implants.Healthy subjects will be chosen and dental implants placed bilaterally one with
 standard surgical protocol and other with the use of Allogenic Mesenchymal Stem cells.The
 implant stability is checked using Resonance frequency analysis(RFA).The RFA values are
 statistically evaluated at various intervals and observations will be analysed on both test
 and control side.
This study prospective single center study . A total of 10 patients are selected to be
 treated with dental implants for their bilaterally missing edentulous condition, which can be
 supported by either removable or fixed rehabilitation. The edentulous space can either be in
 maxilla or mandible. The study is performed at the Department of Implantology (Sri Sai
 College Of Dental Surgery and Research Center, Vikarabad, India). The study is approved by
 institutional ethics committee (IEC).

 MATERIAL AND METHODS

 1. Nobel Biocare Replace Select Dental Implants of size 4.3x10 mm. Healing abutments and
 implant abutments. 20 Numbers.

 2. Nobel Biocare surgical kit

 3. Nobel Biocare physio dispenser

 4. Transchymal Dental pulp derived Allogenic mesenchymal cells.

 5. Ostell ISQ device along with a Smart peg.

 6. A Centrifuge.

 7. Sterile centrifuge tubes,

 8. Sterile pipettes

 9. Bone roungers

 10. IOPA and KKD Radiographic system

 11. Cold saline

 12. Suture material and suture needles

 13. 70% isopropanol

 14. Chiller and a Thermo cool box to carry dry ice

 15. Sterile cotton and gauze

 16. Mouth mirror

 17. Dental examination Probe

 18. Needle holder

 19. Artery Forceps and scissors.

 20. Surgical gown,patient drape, Mouth mask, head cap and surgical gloves

 21. High power suction and suction tips.

 22. Betadine and chlorhexidine mouthwash.

 23. BP blade handle and BP blade no 11,12 and 15

 24. Canon DSLR camera

 25. Patient models and surgical guide

 26. Informed and written consent forms.

 27. Case history records

 28. Photography and videography waiver consent form

 29. Ethical Clearance Certificate

 30. CBCT

 31. Vital parameters data sheet

 32. Diagnostic reports of CBP, RBS, CT, BT and Hg%

 33. Antibiotic and anti-allergic prophylaxis.

 34. A local anesthetic solution containing 2% lignocaine with 1:100,000-epinephrine and 2ml
 disposable syringe.

 35. Statistical analysis software IBM SPSS version 19.

 METHODS

 Clinical Procedure

 Pre-operative planning is based on clinical and radiographic examination. After thoroughly
 recording the case history. The following investigations will be done prior to implant
 placement surgery: CBCT, CBP, CT, BT, Hg%, RBS, Vital signs and other relevant
 investigations. If all the parameters fulfill the inclusion and exclusion criteria, the
 patient's impressions are made and study models poured. Intraoral and extraoral photographs
 are taken. The surgical guide is constructed on the diagnostic models.Stem cells are carried
 from stem cell bank to the Department of Implantology in a cryovial, safely placed in the
 special device, which contains dry ice, to maintain the viability of stem cells.

 Surgical Procedure

 On the day of surgery, the dental operatory is thoroughly fumigated and all the infection
 control protocols are followed.The participants will be receiving oral and written
 information about the study and shall be providing the informed consent along with
 photography and videography waiver consent. Antimicrobial prophylaxis (amoxicillin 1gm) and
 antihistamine prophylaxis (20mg cetirizine) orally 1 hour before surgery should be given to
 the patient. The universal precautions protocol is followed to protect yourself, the patients
 and the dental assistant.The patient is asked to rinse the Oral cavity with chlorhexidine
 gluconate solution (0.2%) for 1 minute before surgery.

 IMPLANT PLACEMENT ON THE CONTROL SIDE

 To standardized the protocol the patient's right side is selected as the control side and
 left side as the test side. The surgical procedure is carried out under local anesthesia
 containing 2% epinephrine with 1:100,000 epinephrine. The surgical guide is placed on the
 teeth and is used to mark the position of the implant with round drill till it hits the bone.
 Mucoperiosteal flaps were raised with mid crestal incision and intrasulcular incision
 extending to one tooth mesially and other teeth distally. After full thickness flap
 elevation, the osteotomy sites are prepared using the drilling sequence instructed by the
 manufacturer.The dental implants Nobel Biocare Replace select (4.3 *10mm size) 4.3mm diameter
 and 10mm length is selected and placed in the osteotomy site with IF of 40 Ncm.Before
 approximation of the flap, the primary stability of the implant is recorded with the ostell
 device, which has a transducer attached to the device and a magnetic attachment smart peg is
 attached to the implant with a plastic peg holder each implant is measured twice from two
 different angles,around 90 degrees and parallel to the crestal line.The two measurements
 buccolingually and mesiodistally are recorded and an average of both the values are taken.The
 measurements values are then transferred into implant stability quotient (ISQ) units, which
 are given on a scale of 1- 100, with 100 being the highest degree of stability and it works
 on the principle of resonance frequency analysis (RFA).The smart peg is removed and Healing
 abutments are placed over the dental implants. The flap is sutured monofilament sutures 4-0.
 IOPAR are taken with KKD Radiograph system, which standardizes the distance between the
 collimator and the IOPAR.

 IMPLANT PLACEMENT ON THE TEST SIDE

 To standardized the protocol the patient's left side is chosen as the test side.The surgical
 procedure is carried out under local anesthesia containing 2% epinephrine with 1:100,000
 epinephrine. The surgical guide is placed on the teeth and is used to mark the position of
 the implant with round drill till it hits the bone. Mucoperiosteal flaps were raised with mid
 crestal incision and intrasulcular incision extending to one tooth mesially and another tooth
 distally. After full thickness flap elevation, the osteotomy sites are prepared using the
 drilling sequence instructed by the manufacturer. the stem cells are centrifuged in a sterile
 environment as per the instructions are given by the stem cell bank.(Thawing protocol )Human
 mesenchymal stem cells (hMSC) are primary cells which can be successfully used for infusion
 purpose.The following is the recommended protocol for thawing and infusion of these
 cells:Remove the Cryovial of stem cells from dry ice,defrost the vial containing stem cells
 by placing in between both the palms with constant, moderate agitation, until ice in the
 ampule is no longer visible,immediately disinfect the vial with 70% isopropanol.Working under
 laminar flow hood, open the vial and transfer the contents to a sterile 15ml centrifuge tube
 and centrifuge at 3500 RPM for 5 minutes. Decant the supernatant and to the pellet add 1 ml
 of saline.Mix properly and the cells are ready for infusion at the osteotomy site. Remove the
 contents in a sterile dappen dish and before infusion of stem cells at the osteotomy site the
 implant is dipped in the solution for 3 minutes so that the stem cells adhere to the titanium
 implant surface. The same dental surgeon performs all the cases. The dental implants Nobel
 Biocare Replace select (4.3 *10mm size) 4.3mm diameter and 10mm length is selected and placed
 in the osteotomy site with IF of 40 Ncm11.Before approximation of the flap, the primary
 stability of the implant is recorded with the ostell device, which has a transducer attached
 to the device and a magnetic attachment smart peg is attached to the implant with a plastic
 peg holder each implant is measured twice from two different angles,around 90 degrees and
 parallel to the crestal line.The two measurements buccolingually and mesiodistally are
 recorded and an average of both the values are taken.The measurements values are then
 transferred into implant stability quotient (ISQ) units, which are given on a scale of 1-
 100, with 100 being the highest degree of stability and it works on the principle of
 resonance frequency analysis (RFA).The smart peg is removed and Healing abutments are placed
 over the dental implants. The flap is sutured monofilament sutures 4-0.IOPAR are taken with
 KKD radiograph system, which standardizes the distance between the collimator and the IOPAR.

 POST SURGICAL TREATMENT

 The patient is advised to take soft diet for one week and not to spit and rinse for the next
 24 hours. Antibiotics, Antihistamines, and NSAIDs must be continued for 3 days. Postoperative
 edema if any must be controlled with corticosteroids. The sutures are removed one week
 postoperatively.

 Recall visits

 Weekly recall of the patient for 12 weeks for evaluation and recording of implant stability
 measurements with Ostell ISQ device. Patient safety measures are evaluated on every visit
 like unusual pain, swelling, allergic reaction, inflammation, outgrowth, vital signs, blood
 assay or any unspecific reactions should be noted down. The emergency contact number is
 provided to the patient to report any abnormal incidence immediately. The prosthetic part of
 the treatment is to be carried out after 3 months either with removable or fixed
 rehabilitation.

 Statistical analysis

 Descriptive statistics will be computed to summarize the data for its central tendency and
 dispersion. Two sample t-test will be applied to see the mean change in the outcome variable
 between experimental and control groups. Repeated measures of ANOVA are being applied to see
 the time changes between experimental and control groups. Where ever data is not following
 uniformity, either transforming the data or nonparametric statistical technique will be
 applied. The analysis will be performed using IBM SPSS Version 19.0.
Inclusion Criteria:

 1. Patients with bilateral edentulous condition either partial or complete.

 2. Patients maintaining adequate oral hygiene

 3. Patients with dimensions of alveolar jaw bone in Occlusso-Gingival position >10mm and
 Bucco-Lingual position < 6mm.

 Exclusion Criteria:

 1. Systemic diseases which are likely to compromise Implant surgery like Diabetes
 Mellitus Type I, II and Osteoporosis.

 2. Patients with oral parafunctional habits like Bruxism.

 3. Smokers who smoke more than 10 cigarettes a day.

 4. Self-declared pregnancy or intention to become Pregnant.

 5. The use of Regenerative procedures in conjunction with Implant placement.Eg- Grafts
 ,Sinus Lift procedures.