Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453330
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
A Randomised Control Clinical Trial Investigating the Effect of H-PRF on Implant Stability and Marginal Bone Levels
Sponsor:
University of Dublin Trinity College
Organization:
University of Dublin Trinity College
Study Overview
Official Title:
A Randomised Control Clinical Trial Investigating the Effect of Horizontal-Platelet-Rich Fibrin H-PRF vs Standard Placement on Implant Stability and Marginal Bone Levels in Adults
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
None
Brief Summary:
This research will be a randomised controlled trial RCT investigating whether the use of Horizontal Platelet Rich Fibrin H-PRF increases implant stability compared to those implants placed without H-PRF and therefore contributes to the implants overall success
H-PRF is a second generation platelet concentrate that consists of a fibrin mesh containing cytokines and leukocytes It has been shown to stimulate mesenchymal stem cells and osteoblasts that encourage bone formation as a result of the growth factors released from platelets which should aid in osseointegration of implants There is limited research that investigates the effects of H-PRF on implant stability There is however some evidence that platelet-rich fibrin PRF which is produced in a fixed-angle centrifuge increases implant stability and H-PRF is considered the evolution of PRF products
This research would follow a H-PRF preparation protocol which involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood After the tube of blood is collected it would immediately be placed in a horizontal centrifuge machine with 3 tubes of water to balance the centrifuge and placed opposite each other A set rpm and time will be chosen and the centrifuge will run until the time is complete The H-PRF clots would then be ready and taken out of the tubes to separate them from the red blood cells
Following randomisation implants will be placed in the upper or lower jaws of patients attending the Dublin Dental University Hospital using the standard implant protocol Half of the implants will be coated with H-PRF the other half control group would be placed without HPRF Implant stability and marginal bone levels will be measured at three different stages 1 Initial implant placement 2 Second stage surgery when the implant is uncovered after healing and integrated with the bone 3 When the definitive crown or bridge is attached to the implant Insertion torque at baseline will also be measured The above results will be collected and assessed to determine the effects of H-PRF if any on implant stability and the preservation of bone levels around implants
H-PRF is a second generation platelet concentrate that consists of a fibrin mesh containing cytokines and leukocytes It has been shown to stimulate mesenchymal stem cells and osteoblasts that encourage bone formation as a result of the growth factors released from platelets which should aid in osseointegration of implants There is limited research that investigates the effects of H-PRF on implant stability There is however some evidence that platelet-rich fibrin PRF which is produced in a fixed-angle centrifuge increases implant stability and H-PRF is considered the evolution of PRF products
This research would follow a H-PRF preparation protocol which involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood After the tube of blood is collected it would immediately be placed in a horizontal centrifuge machine with 3 tubes of water to balance the centrifuge and placed opposite each other A set rpm and time will be chosen and the centrifuge will run until the time is complete The H-PRF clots would then be ready and taken out of the tubes to separate them from the red blood cells
Following randomisation implants will be placed in the upper or lower jaws of patients attending the Dublin Dental University Hospital using the standard implant protocol Half of the implants will be coated with H-PRF the other half control group would be placed without HPRF Implant stability and marginal bone levels will be measured at three different stages 1 Initial implant placement 2 Second stage surgery when the implant is uncovered after healing and integrated with the bone 3 When the definitive crown or bridge is attached to the implant Insertion torque at baseline will also be measured The above results will be collected and assessed to determine the effects of H-PRF if any on implant stability and the preservation of bone levels around implants
Detailed Description:
This is a parallel arm randomised control clinical Trial RCT on a cohort of Dublin Dental University Hospital patients who are having dental implants placed in the maxilla or mandible
Study sample
1 Subjects will be recruited from a population of patients who have been referred to Dublin University Dental Hospital from general practice or specialist practice for provision of implants
2 Subjects will be recruited from a population of patients who have been referred from another department within the Dublin Dental Hospital for provision of implants
Enrolment and Consent
Participants will be selected via two methods
1 Subjects will be recruited from a population of patients who have been referred to Dublin University Dental Hospital from general practice or specialist practice for provision of implants
2 Subjects will be recruited from a population of patients who have been referred from another department within the Dublin Dental University Hospital for provision of implants Patients being referred for implants to the Dublin Dental University hospital initially attend a dental implant assessment appointment If at that appointment they are deemed suitable to be enrolled in the study a gatekeeper Ms Niamh Leonard will invite the patient to take part in the research study Please note that Ms Niamh Leonard is an experienced gatekeeper and an administrator in the Division of Restorative Dentistry and Periodontology in the Dublin Dental Hospital but is not involved in study patients care She will only be involved in inviting patients to take part in the study Patients will have an opportunity to discuss the study in detail and will be provided with a written copy of the Patient Information Leaflet PIL to take home For any question that may arise regarding the research or the surgical procedure patients will be able to contact the co-investigator Dr Rawan Kahatab as the contact details appear on the information leaflet Patients will be given time at least 7 days to consider their participation and can contact the gatekeeper if they opt to participate Patients will sign a freely given informed consent form prior to their enrolment in the study
If a single patient will be receiving more than one dental implants and there are numerous implant sites that qualify for entry into the research only one of the implant sites will be randomly selected for the study If a patient opts not to participate it will not affect their care
Randomisation
At the time of surgery each patient will select a numbered sealed envelope with the treatment group allocation Each envelope will correspond to a number on a computer-generated randomisation list created prior to enrolment of study participants The operator will then use either the H-PRF or not use H-PRF when placing the implant depending on what was revealed when the envelope was opened Neither the operator or the patient can be blinded to the arm chosen as blood sample will only be taken for the H-PRF group
The blood sample collection and surgeries will be performed by Dr Rawan Kahatab
H-PRF is used regularly in the DDUH and the clinical protocol will not deviate from standard procedures used at the hospital H-PRF preparation protocol involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood After the first tube is collected it would immediately be placed in a horizontal centrifuge machine balanced out with 3 tubes of water to ensure the centrifuge is properly balanced A set rpm and time will be chosen and the centrifuge will run until the time is complete The H-PRF clots would then be ready and taken out of the tubes to separate them from the red blood cells Peri-apical radiographs of the surgical site are taken pre-operatively at implant placement and at implant restoration for all implants placed at the Dublin Dental University Hospital
________________________________________________________________
Similar studies that have previously been carried out to assess the effect of PRF on implant stability have focused on PRF produced from fixed-angle systems as opposed to horizontal ones However they have followed a very similar design to our proposed design For example in a study by Tabrizi et al 2017 a split-mouth randomised clinical trial was performed Twenty patients with missing teeth in the molar region of the maxilla requiring bilateral implants were included PRF was used on one side group 1 no PRF was used on the other group 2 Implant stability was assessed by resonance frequency analysis RFA at 2 4 and 6 weeks after placement At 2 weeks the mean ISQ was 6060 342 in group 1 and 5825 364 in group 2 at 4 weeks it was 7030 336 in group 1 and 6715 433 in group 2 at 6 weeks it was 7845 336 in group 1 and 7615 294 in group 2 Significant differences in RFA were found between the groups at 2 weeks P 004 4 weeks P 0014 and 6 weeks P 0027 after placement
The study results suggest that the use of PRF may enhance the post-insertion stability of dental implants placed in the posterior maxilla during the healing period In another study by Oncu et al 2015 twenty healthy patients with adequate alveolar bone and two or more adjacent missing teeth extracted at least 6 months previously were included A minimum of two tapered implants were placed in each patient After surgical preparation of the implant sockets PRF that had been prepared preoperatively was placed randomly into one of the sockets Resonance frequency measurements were made after implant placement and at 1 week and 1 month postoperatively Mean implant stability quotients ISQs of the PRF implants was 693 105 and mean ISQs for the PRF- implants was 645 122 at the end of the first week The mean ISQs at 4 weeks postoperatively were 771 71 for the PRF group and 705 77 for the group without PRF In this study PRF application increased implant stability during the early healing period as evidenced by higher ISQ values Based on the results of these studies and the fact that H-PRF is an even more superior biomaterial than PRF our study should achieve outcomes that are just as successful
Study sample
1 Subjects will be recruited from a population of patients who have been referred to Dublin University Dental Hospital from general practice or specialist practice for provision of implants
2 Subjects will be recruited from a population of patients who have been referred from another department within the Dublin Dental Hospital for provision of implants
Enrolment and Consent
Participants will be selected via two methods
1 Subjects will be recruited from a population of patients who have been referred to Dublin University Dental Hospital from general practice or specialist practice for provision of implants
2 Subjects will be recruited from a population of patients who have been referred from another department within the Dublin Dental University Hospital for provision of implants Patients being referred for implants to the Dublin Dental University hospital initially attend a dental implant assessment appointment If at that appointment they are deemed suitable to be enrolled in the study a gatekeeper Ms Niamh Leonard will invite the patient to take part in the research study Please note that Ms Niamh Leonard is an experienced gatekeeper and an administrator in the Division of Restorative Dentistry and Periodontology in the Dublin Dental Hospital but is not involved in study patients care She will only be involved in inviting patients to take part in the study Patients will have an opportunity to discuss the study in detail and will be provided with a written copy of the Patient Information Leaflet PIL to take home For any question that may arise regarding the research or the surgical procedure patients will be able to contact the co-investigator Dr Rawan Kahatab as the contact details appear on the information leaflet Patients will be given time at least 7 days to consider their participation and can contact the gatekeeper if they opt to participate Patients will sign a freely given informed consent form prior to their enrolment in the study
If a single patient will be receiving more than one dental implants and there are numerous implant sites that qualify for entry into the research only one of the implant sites will be randomly selected for the study If a patient opts not to participate it will not affect their care
Randomisation
At the time of surgery each patient will select a numbered sealed envelope with the treatment group allocation Each envelope will correspond to a number on a computer-generated randomisation list created prior to enrolment of study participants The operator will then use either the H-PRF or not use H-PRF when placing the implant depending on what was revealed when the envelope was opened Neither the operator or the patient can be blinded to the arm chosen as blood sample will only be taken for the H-PRF group
The blood sample collection and surgeries will be performed by Dr Rawan Kahatab
H-PRF is used regularly in the DDUH and the clinical protocol will not deviate from standard procedures used at the hospital H-PRF preparation protocol involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood After the first tube is collected it would immediately be placed in a horizontal centrifuge machine balanced out with 3 tubes of water to ensure the centrifuge is properly balanced A set rpm and time will be chosen and the centrifuge will run until the time is complete The H-PRF clots would then be ready and taken out of the tubes to separate them from the red blood cells Peri-apical radiographs of the surgical site are taken pre-operatively at implant placement and at implant restoration for all implants placed at the Dublin Dental University Hospital
________________________________________________________________
Similar studies that have previously been carried out to assess the effect of PRF on implant stability have focused on PRF produced from fixed-angle systems as opposed to horizontal ones However they have followed a very similar design to our proposed design For example in a study by Tabrizi et al 2017 a split-mouth randomised clinical trial was performed Twenty patients with missing teeth in the molar region of the maxilla requiring bilateral implants were included PRF was used on one side group 1 no PRF was used on the other group 2 Implant stability was assessed by resonance frequency analysis RFA at 2 4 and 6 weeks after placement At 2 weeks the mean ISQ was 6060 342 in group 1 and 5825 364 in group 2 at 4 weeks it was 7030 336 in group 1 and 6715 433 in group 2 at 6 weeks it was 7845 336 in group 1 and 7615 294 in group 2 Significant differences in RFA were found between the groups at 2 weeks P 004 4 weeks P 0014 and 6 weeks P 0027 after placement
The study results suggest that the use of PRF may enhance the post-insertion stability of dental implants placed in the posterior maxilla during the healing period In another study by Oncu et al 2015 twenty healthy patients with adequate alveolar bone and two or more adjacent missing teeth extracted at least 6 months previously were included A minimum of two tapered implants were placed in each patient After surgical preparation of the implant sockets PRF that had been prepared preoperatively was placed randomly into one of the sockets Resonance frequency measurements were made after implant placement and at 1 week and 1 month postoperatively Mean implant stability quotients ISQs of the PRF implants was 693 105 and mean ISQs for the PRF- implants was 645 122 at the end of the first week The mean ISQs at 4 weeks postoperatively were 771 71 for the PRF group and 705 77 for the group without PRF In this study PRF application increased implant stability during the early healing period as evidenced by higher ISQ values Based on the results of these studies and the fact that H-PRF is an even more superior biomaterial than PRF our study should achieve outcomes that are just as successful
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None