Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02731586
Status:
UNKNOWN
Last Update Posted:
2017-10-06
First Post:
2016-04-03
Brief Title:
Effect on Allogenic Mesenchymal Stem Cells on Osseointegration of Dental Implants
Sponsor:
Sri Sai College of Dental Surgery and Research Centre
Organization:
Sri Sai College of Dental Surgery and Research Centre
Study Overview
Official Title:
Comparative Clinical Evaluation of Osseointegration of Dental Implants Placed With and Without the Use of Dental Pulp-derived Allogenic Mesenchymal Stem Cells
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSCIMPLANTS
Brief Summary:
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 applicationsThis study aims to evaluate the overall effect of osseointegration by use of Allogenic Mesenchymal Stem cells while placing dental implantsHealthy subjects will be chosen and dental implants placed bilaterally one with standard surgical protocol and other with the use of Allogenic Mesenchymal Stem cellsThe implant stability is checked using Resonance frequency analysisRFAThe RFA values are statistically evaluated at various intervals and observations will be analysed on both test and control side
Detailed Description:
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 43x10 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 gownpatient 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 1112 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 1100000-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 patients impressions are made and study models poured Intraoral and extraoral photographs are taken The surgical guide is constructed on the diagnostic modelsStem 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 followedThe 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 assistantThe patient is asked to rinse the Oral cavity with chlorhexidine gluconate solution 02 for 1 minute before surgery
IMPLANT PLACEMENT ON THE CONTROL SIDE
To standardized the protocol the patients 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 1100000 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 manufacturerThe dental implants Nobel Biocare Replace select 43 10mm size 43mm diameter and 10mm length is selected and placed in the osteotomy site with IF of 40 NcmBefore 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 anglesaround 90 degrees and parallel to the crestal lineThe two measurements buccolingually and mesiodistally are recorded and an average of both the values are takenThe 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 RFAThe 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 patients left side is chosen as the test sideThe surgical procedure is carried out under local anesthesia containing 2 epinephrine with 1100000 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 bankThawing protocol Human mesenchymal stem cells hMSC are primary cells which can be successfully used for infusion purposeThe following is the recommended protocol for thawing and infusion of these cellsRemove the Cryovial of stem cells from dry icedefrost the vial containing stem cells by placing in between both the palms with constant moderate agitation until ice in the ampule is no longer visibleimmediately disinfect the vial with 70 isopropanolWorking 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 salineMix 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 43 10mm size 43mm diameter and 10mm length is selected and placed in the osteotomy site with IF of 40 Ncm11Before 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 anglesaround 90 degrees and parallel to the crestal lineThe two measurements buccolingually and mesiodistally are recorded and an average of both the values are takenThe 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 RFAThe smart peg is removed and Healing abutments are placed over the dental implants The flap is sutured monofilament sutures 4-0IOPAR 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 190
MATERIAL AND METHODS
1 Nobel Biocare Replace Select Dental Implants of size 43x10 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 gownpatient 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 1112 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 1100000-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 patients impressions are made and study models poured Intraoral and extraoral photographs are taken The surgical guide is constructed on the diagnostic modelsStem 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 followedThe 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 assistantThe patient is asked to rinse the Oral cavity with chlorhexidine gluconate solution 02 for 1 minute before surgery
IMPLANT PLACEMENT ON THE CONTROL SIDE
To standardized the protocol the patients 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 1100000 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 manufacturerThe dental implants Nobel Biocare Replace select 43 10mm size 43mm diameter and 10mm length is selected and placed in the osteotomy site with IF of 40 NcmBefore 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 anglesaround 90 degrees and parallel to the crestal lineThe two measurements buccolingually and mesiodistally are recorded and an average of both the values are takenThe 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 RFAThe 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 patients left side is chosen as the test sideThe surgical procedure is carried out under local anesthesia containing 2 epinephrine with 1100000 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 bankThawing protocol Human mesenchymal stem cells hMSC are primary cells which can be successfully used for infusion purposeThe following is the recommended protocol for thawing and infusion of these cellsRemove the Cryovial of stem cells from dry icedefrost the vial containing stem cells by placing in between both the palms with constant moderate agitation until ice in the ampule is no longer visibleimmediately disinfect the vial with 70 isopropanolWorking 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 salineMix 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 43 10mm size 43mm diameter and 10mm length is selected and placed in the osteotomy site with IF of 40 Ncm11Before 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 anglesaround 90 degrees and parallel to the crestal lineThe two measurements buccolingually and mesiodistally are recorded and an average of both the values are takenThe 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 RFAThe smart peg is removed and Healing abutments are placed over the dental implants The flap is sutured monofilament sutures 4-0IOPAR 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 190
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None