Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869292
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2023-05-11
Brief Title:
Immediate Vs Early Loading of Immediately Placed Implants
Sponsor:
University of Belgrade
Organization:
University of Belgrade
Study Overview
Official Title:
Immediate Vs Early Loading of Immediately Placed Bone Level Tapered Dental Implants
Status:
COMPLETED
Status Verified Date:
2023-05
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:
The study aims to compare implant stabilities between immediate and early loaded immediately placed bone-level tapered dental implants in the upper jaw in the partial and total edentulous patients assessing marginal bone loss oral health-related quality of life and patient satisfaction within one two and five years of follow-ups
Detailed Description:
The objectives of the study
The primary objective of this study will be to compare primary and secondary stability between immediate and early loaded immediately placed bone-level tapered dental implants in the upper jaw in partial and total edentulous patients The second objective will be marginal bone level changes and soft tissue changes such as keratinised tissue width and gingival thickness which will be assessed at one two and five years postoperatively The gained results will assess and compared within partial and total edentulous patients
Additionally the study also will be analyse functional and aesthetic outcomes as well as the possibility of the complication and its prevalences including biological mechanical and procedure-related complications comparing the their incidence between partial and total edentulous patients
Materials and methods
The study is design as a prospective randomised controlled clinical trial which will be conducted at School of Dental Medicine in accordance with the Declaration of Helsinki World Medical Association 2013 and the CONSORT Statement
Before the treatment procedure after clinical examination patients will be divided into two groups
1 Group A- patient requires on both sides one implant to be placed
2 Group B- patient requires full-arch reconstruction
Thereafter in the both groups patients will be randomly divided into two subgroups in which immediate loading test group or early loading six week postoperatively will be performed
Surgical procedure
One hour before the surgery antibiotic prophylaxis will be administered and the patients should rins their mouths with 012 chlorhexidine solution for 1 minute preoperatively The procedures will be performed under local anesthesia using 4 articaine 1100000 epinephrine A midcrestal incision will be made and full-thickness will be elevated Failing tooth or teeth will be extracted using periotomes elevators and forceps to preserve socket walls integrity Extracted alveolus will be immediately prepared following by the epicrestal or subcrestal implant placement If the gap between the implant surfaces and socket walls is wider than 2 mm bovine-derived xenograft Geistlich Bio-Oss Wolhusen Switzerland and collagen membrane Geistlich Bio-Gide Wolhusen Switzerland will be placed Healing screws Institute Straumann AG Basel Switzerland NC healing abutment 48 mm conical 5 mm and RC healing abutment 5 mm conical 6 mm will be placed and primary wound closure was achieved with 5-0 single resorbable sutures AssuCryl Lactin Pully-Lausanne Switzerland The presence of apical fenestration cortical dehiscence an apico-marginal defect or the need for contour augmentation will also recorded in the patient study charts Patients will be prescribed antibiotic therapy for the next five days Amoxicillin with clavulonic acid 1 g twice a day or in case of allergy Clindamycin 06 g three times a day
23 Prosthetic protocol
Implants in subgroup marked as the test group will be immediately loaded with temporary restorations using S-R abutments Institute Straumann AG Basel Switzerland whereas the patients from the subgroup marked as control group wouldnt receive any kind of prosthetic restauration and will left with healing abutments HA
For the provisional restoration an open tray impression technique will be used Plaster models with scan bodies will be digitized by the laboratory scanner 3Shape E1 3Shape Kopenhagen Denmark and the virtual design of provisional restoration will be performed with 3D designing software Exocad-Matera 23 Exocad Darmstadt Germany Provisional restorations will be then created using polymethyl methacrylate PMMA TelioCAD Ivoclar Vivadent Schaan Lichtenstein and were drilled from PMMA blocks using the 5-axis milling machine Zenotec Select Wieland Pforzheim Germany Screw-retained abutments for the prosthetic bridge will be chosen according to implant angulation and surrounding soft tissue height
At the end of the six-week healing period definitive prosthetic restorations will be manufactured and delivered to the patients in both groups
Data Collection and measurements
Implant stability assessed as the primary study outcome was measured using the Resonance Frequency Analysis RFA method with Osstell Mentor Osstell Gothenburg Sweden Fig 7b and Penguin PenguinRFA Gothenburg Sweden
Marginal bone loss will be assessed as the difference between the postoperative and followed up years by means of CBCT measurements
The distance between the implant shoulder and the crestal bone will be estimated as the shortest distance using the same HA for each patient
The results will be statistically analysed
The primary objective of this study will be to compare primary and secondary stability between immediate and early loaded immediately placed bone-level tapered dental implants in the upper jaw in partial and total edentulous patients The second objective will be marginal bone level changes and soft tissue changes such as keratinised tissue width and gingival thickness which will be assessed at one two and five years postoperatively The gained results will assess and compared within partial and total edentulous patients
Additionally the study also will be analyse functional and aesthetic outcomes as well as the possibility of the complication and its prevalences including biological mechanical and procedure-related complications comparing the their incidence between partial and total edentulous patients
Materials and methods
The study is design as a prospective randomised controlled clinical trial which will be conducted at School of Dental Medicine in accordance with the Declaration of Helsinki World Medical Association 2013 and the CONSORT Statement
Before the treatment procedure after clinical examination patients will be divided into two groups
1 Group A- patient requires on both sides one implant to be placed
2 Group B- patient requires full-arch reconstruction
Thereafter in the both groups patients will be randomly divided into two subgroups in which immediate loading test group or early loading six week postoperatively will be performed
Surgical procedure
One hour before the surgery antibiotic prophylaxis will be administered and the patients should rins their mouths with 012 chlorhexidine solution for 1 minute preoperatively The procedures will be performed under local anesthesia using 4 articaine 1100000 epinephrine A midcrestal incision will be made and full-thickness will be elevated Failing tooth or teeth will be extracted using periotomes elevators and forceps to preserve socket walls integrity Extracted alveolus will be immediately prepared following by the epicrestal or subcrestal implant placement If the gap between the implant surfaces and socket walls is wider than 2 mm bovine-derived xenograft Geistlich Bio-Oss Wolhusen Switzerland and collagen membrane Geistlich Bio-Gide Wolhusen Switzerland will be placed Healing screws Institute Straumann AG Basel Switzerland NC healing abutment 48 mm conical 5 mm and RC healing abutment 5 mm conical 6 mm will be placed and primary wound closure was achieved with 5-0 single resorbable sutures AssuCryl Lactin Pully-Lausanne Switzerland The presence of apical fenestration cortical dehiscence an apico-marginal defect or the need for contour augmentation will also recorded in the patient study charts Patients will be prescribed antibiotic therapy for the next five days Amoxicillin with clavulonic acid 1 g twice a day or in case of allergy Clindamycin 06 g three times a day
23 Prosthetic protocol
Implants in subgroup marked as the test group will be immediately loaded with temporary restorations using S-R abutments Institute Straumann AG Basel Switzerland whereas the patients from the subgroup marked as control group wouldnt receive any kind of prosthetic restauration and will left with healing abutments HA
For the provisional restoration an open tray impression technique will be used Plaster models with scan bodies will be digitized by the laboratory scanner 3Shape E1 3Shape Kopenhagen Denmark and the virtual design of provisional restoration will be performed with 3D designing software Exocad-Matera 23 Exocad Darmstadt Germany Provisional restorations will be then created using polymethyl methacrylate PMMA TelioCAD Ivoclar Vivadent Schaan Lichtenstein and were drilled from PMMA blocks using the 5-axis milling machine Zenotec Select Wieland Pforzheim Germany Screw-retained abutments for the prosthetic bridge will be chosen according to implant angulation and surrounding soft tissue height
At the end of the six-week healing period definitive prosthetic restorations will be manufactured and delivered to the patients in both groups
Data Collection and measurements
Implant stability assessed as the primary study outcome was measured using the Resonance Frequency Analysis RFA method with Osstell Mentor Osstell Gothenburg Sweden Fig 7b and Penguin PenguinRFA Gothenburg Sweden
Marginal bone loss will be assessed as the difference between the postoperative and followed up years by means of CBCT measurements
The distance between the implant shoulder and the crestal bone will be estimated as the shortest distance using the same HA for each patient
The results will be statistically analysed
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