Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444334
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-05-30
Brief Title:
Laser Biostimulation on Implant Covered With PRF in Controlled Diabetics
Sponsor:
National Research Centre Egypt
Organization:
National Research Centre Egypt
Study Overview
Official Title:
Evaluation of the Effect of Laser Biostimulation on Implant Covered With PRF in Controlled Diabetic Patients A Randomized Clinical Trial
Status:
COMPLETED
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:
PRF
Brief Summary:
the goal of this clinical trial is to evaluate laser biostimulation effect on osseointegration of implant covered by PRFplatelet rich fibrin in controlled diabetic patients with compromised healing potential
METHODS The study was conducted on type 2 controlled diabetic patients receiving 22 implants covered with PRF inserted in posterior maxilla or mandible Implants were divided randomly into 2 groups Group1 control group received no laser irradiation group2 received diode laser Peri-implant new bone density and secondary stability were assessed using cone-beam computed tomography and Anycheck device respectively Density was evaluated immediately post implant insertion and after 5 months while implant stability was performed 5 months post implant insertion Statistical analysis was executed significance level P 005
METHODS The study was conducted on type 2 controlled diabetic patients receiving 22 implants covered with PRF inserted in posterior maxilla or mandible Implants were divided randomly into 2 groups Group1 control group received no laser irradiation group2 received diode laser Peri-implant new bone density and secondary stability were assessed using cone-beam computed tomography and Anycheck device respectively Density was evaluated immediately post implant insertion and after 5 months while implant stability was performed 5 months post implant insertion Statistical analysis was executed significance level P 005
Detailed Description:
Study type
randomized controlled clinical trial
Study design
Controlled type II diabetic patients with edentulous posterior areas were randomly selected from dental clinic of Medical and Scientific Centre of Excellence MSCE National Research Centre NRC Cairo Egypt according to inclusion and exclusion criteria to receive a total number of twenty-two dental implants Implants were randomly distributed with 11 allocation ratio into two groups according to exposure to laser irradiation Group 1 was not exposed to laser irradiation control group while group 2 was exposed to laser irradiation Peri-implant new bone density was evaluated immediately post implant insertion and after 5 months while secondary implant stability was performed 5 months post implant insertion
This study was prosecuted with the Code of Ethics of the World Medical Association they were stated in the Declaration of Helsinki in 1975 Medical Research Ethical Committee of the National Research Centre Cairo Egypt permitted this study with approval number 03430423 All patients were familiar with the studys treatment phases and signed a consent form The study was conducted from January 2023 to March 2024
Radiographic procedures
Every patient had undergone radiographic analysis pre-operatively using cone beam computed tomography CBCT The intended size and location of the implants were determined and planned virtually by digital software Planmeca Romexis Viewer 62119 Bone density around the implants will be evaluated using CBCT software at immediately postoperative as baseline and 5 months postoperative Both groups were radiographed by cone beam CT for evaluation and assessment of bone density around implants by professional blinded investigators Planmeca Romaxies machine was used with the following specifications Field of View FOV 80x50 cm resolution 0300 orientation portrait 90 kV 80mA and exposure time 15019 sec
Surgical procedures
Implants K1 line conical connection double thread OXY Italy were inserted under profound local anesthesia using free hand open flap technique where mucoperiosteal gingival envelop full thickness flap was performed by crestal incision mucoperiosteal reflection exposing bone The preplanned location was confirmed by the aid of CBCT then sequential drilling was exerted using graduated drills with stoppers under copious amount of saline coolant with the aid of paralleling pins if multiple implants were inserted to be splinted in the same patient
Implants were screwed with torque between 35-45N to ensure primary stability Various implants sizes were utilized ranging from 4 mm to 55mm in diameter and from 8mm to 11mm in length in accordance with the virtual pre-plan based on bone geometrical availability The procedure was executed by a single well-experienced operator who was blinded to the groups
PRF preparation protocol
The preparation method of PRF was performed in accordance with the protocol developed by Choukroun PRF was withdrawn and processed from the same operated-on patients blood 6ml IV blood withdrawn from the antecubital vein in to two sterile 3ml red vacutainer tubes without anticoagulant followed by a 12 minute centrifuge with 3000 RPM producing a platelet rich fibrin clot which is then incised separated with 2mm basal layer of RBCs rich in growth factors Following the cover screw placement PRF was extended bucco-lingually and mesio-distally over the alveolar ridge Finally approximation of the flap was achieved using non-resorbable 30 suture which was removed after 7-10 days postoperative Nonsteroidal anti-inflammatory drugs and antibiotics were administered for seven days Delayed loading was initiated after 5 months of osseointegration process
Laser irradiation protocol
Group 2 was exposed to laser irradiation following implant insertion for 3 sessions Immediately after implant insertion 2 days after implant insertion and 1 week after insertion using a red Diodegallium-aluminum-arsenide LLLT using calibrated diode laser device at 635nm wavelength delivered by biomodulating handpiece with the following set parameters 100mw power output 8mm handpiece diameter continuous mode and time 40 second per point and contact mode The laser probe was directed towards the implant site gently touching the tissues mesially distally buccally and lingually to assure the full exposure of the target surface to laser beam
randomized controlled clinical trial
Study design
Controlled type II diabetic patients with edentulous posterior areas were randomly selected from dental clinic of Medical and Scientific Centre of Excellence MSCE National Research Centre NRC Cairo Egypt according to inclusion and exclusion criteria to receive a total number of twenty-two dental implants Implants were randomly distributed with 11 allocation ratio into two groups according to exposure to laser irradiation Group 1 was not exposed to laser irradiation control group while group 2 was exposed to laser irradiation Peri-implant new bone density was evaluated immediately post implant insertion and after 5 months while secondary implant stability was performed 5 months post implant insertion
This study was prosecuted with the Code of Ethics of the World Medical Association they were stated in the Declaration of Helsinki in 1975 Medical Research Ethical Committee of the National Research Centre Cairo Egypt permitted this study with approval number 03430423 All patients were familiar with the studys treatment phases and signed a consent form The study was conducted from January 2023 to March 2024
Radiographic procedures
Every patient had undergone radiographic analysis pre-operatively using cone beam computed tomography CBCT The intended size and location of the implants were determined and planned virtually by digital software Planmeca Romexis Viewer 62119 Bone density around the implants will be evaluated using CBCT software at immediately postoperative as baseline and 5 months postoperative Both groups were radiographed by cone beam CT for evaluation and assessment of bone density around implants by professional blinded investigators Planmeca Romaxies machine was used with the following specifications Field of View FOV 80x50 cm resolution 0300 orientation portrait 90 kV 80mA and exposure time 15019 sec
Surgical procedures
Implants K1 line conical connection double thread OXY Italy were inserted under profound local anesthesia using free hand open flap technique where mucoperiosteal gingival envelop full thickness flap was performed by crestal incision mucoperiosteal reflection exposing bone The preplanned location was confirmed by the aid of CBCT then sequential drilling was exerted using graduated drills with stoppers under copious amount of saline coolant with the aid of paralleling pins if multiple implants were inserted to be splinted in the same patient
Implants were screwed with torque between 35-45N to ensure primary stability Various implants sizes were utilized ranging from 4 mm to 55mm in diameter and from 8mm to 11mm in length in accordance with the virtual pre-plan based on bone geometrical availability The procedure was executed by a single well-experienced operator who was blinded to the groups
PRF preparation protocol
The preparation method of PRF was performed in accordance with the protocol developed by Choukroun PRF was withdrawn and processed from the same operated-on patients blood 6ml IV blood withdrawn from the antecubital vein in to two sterile 3ml red vacutainer tubes without anticoagulant followed by a 12 minute centrifuge with 3000 RPM producing a platelet rich fibrin clot which is then incised separated with 2mm basal layer of RBCs rich in growth factors Following the cover screw placement PRF was extended bucco-lingually and mesio-distally over the alveolar ridge Finally approximation of the flap was achieved using non-resorbable 30 suture which was removed after 7-10 days postoperative Nonsteroidal anti-inflammatory drugs and antibiotics were administered for seven days Delayed loading was initiated after 5 months of osseointegration process
Laser irradiation protocol
Group 2 was exposed to laser irradiation following implant insertion for 3 sessions Immediately after implant insertion 2 days after implant insertion and 1 week after insertion using a red Diodegallium-aluminum-arsenide LLLT using calibrated diode laser device at 635nm wavelength delivered by biomodulating handpiece with the following set parameters 100mw power output 8mm handpiece diameter continuous mode and time 40 second per point and contact mode The laser probe was directed towards the implant site gently touching the tissues mesially distally buccally and lingually to assure the full exposure of the target surface to laser beam
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