Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358352
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-04-05
Brief Title:
Clinical and Radiographic Assessment of PRF Versus Lutein Placement
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Clinical and Radiographic Assessment of PRF Versus Lutein Placement Around Immediately Placed Dental Implants
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department Faculty of Dentistry Mansoura University
Inclusion criteria 1 Badly destructed maxillary single rooted teeth due to trauma or caries 2 Age between 20 and 45 years 3 Good oral hygiene 4 Patients willing to complete the study follow up intervals 5 Patients will be informed about the aim of the study and a written consent will be obtained The patients have the right to withdraw from the study at any time
Exclusion criteria 1 periapical infection in the teeth to be replaced 2 Alcohol or drug abuse 3 Patients with systemic diseases that absolutely contraindicate implant placement 4 Pregnancy 5 Patients with parafunctional habits bruxism and clenching 6 Uncooperative patients 7 Heavy smokers
7
Patients grouping Patients will be randomly divided into three groups
Group A Immediate implant placement with leaving the gap distance empty
Group B Immediate implant placement then placement of PRF around the implant in the gap distance
Group C Immediate implant placement then placement of lutein around the implant in the gap distance
Clinical evaluation
Patients will be evaluated clinically for
1-Postoperative Pain By using a 10-point Visual Analogue Scale VAS for assessment of pain by the patient on the 1st 3rd and 7th days after surgery10 0-1None 2-4Mild 5-7Moderate 8-10Severe 2 Implant stability Will be assessed at the time of implant insertion and at a period of 3 6 and 12 months intervals Resonance frequency analysis RFA values expressed as implant stability quotient ISQ will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer Osstell Mentor Device with the average of 2 measurements performed with the probe in 2 perpendicular directions
3 Sulcus Bleeding Index SBI An early sign of gingivitis is bleeding on probing and in 1971 Muhlemann and Son described the Sulcus Bleeding Index SBI It will be assessed at 3 6 and 12 months intervals
4 Peri-implant probing depth Depth of the peri-implant sulcus will be made at 3 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue
Radiographic evaluation
conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement It will be done immediately after implant placement after 3 months and after 12 months
Inclusion criteria 1 Badly destructed maxillary single rooted teeth due to trauma or caries 2 Age between 20 and 45 years 3 Good oral hygiene 4 Patients willing to complete the study follow up intervals 5 Patients will be informed about the aim of the study and a written consent will be obtained The patients have the right to withdraw from the study at any time
Exclusion criteria 1 periapical infection in the teeth to be replaced 2 Alcohol or drug abuse 3 Patients with systemic diseases that absolutely contraindicate implant placement 4 Pregnancy 5 Patients with parafunctional habits bruxism and clenching 6 Uncooperative patients 7 Heavy smokers
7
Patients grouping Patients will be randomly divided into three groups
Group A Immediate implant placement with leaving the gap distance empty
Group B Immediate implant placement then placement of PRF around the implant in the gap distance
Group C Immediate implant placement then placement of lutein around the implant in the gap distance
Clinical evaluation
Patients will be evaluated clinically for
1-Postoperative Pain By using a 10-point Visual Analogue Scale VAS for assessment of pain by the patient on the 1st 3rd and 7th days after surgery10 0-1None 2-4Mild 5-7Moderate 8-10Severe 2 Implant stability Will be assessed at the time of implant insertion and at a period of 3 6 and 12 months intervals Resonance frequency analysis RFA values expressed as implant stability quotient ISQ will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer Osstell Mentor Device with the average of 2 measurements performed with the probe in 2 perpendicular directions
3 Sulcus Bleeding Index SBI An early sign of gingivitis is bleeding on probing and in 1971 Muhlemann and Son described the Sulcus Bleeding Index SBI It will be assessed at 3 6 and 12 months intervals
4 Peri-implant probing depth Depth of the peri-implant sulcus will be made at 3 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue
Radiographic evaluation
conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement It will be done immediately after implant placement after 3 months and after 12 months
Detailed Description:
None
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