Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412380
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-05-08
Brief Title:
Influence of Insertion Torque and Bone Type on Post-operative Pain
Sponsor:
University of Sharjah
Organization:
University of Sharjah
Study Overview
Official Title:
Influence of High Insertion Torque and Type of Bone on Post-operative Pain and Survival Rate of Dental Implants
Status:
COMPLETED
Status Verified Date:
2024-07
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 objectives of this clinical study were to assess the effect of different ITs and bone types on POP levels and survival rates and to investigate the effect of different patient- and site-related factors on POP levels and survival rates
Detailed Description:
This prospective clinical study included 230 patients treated with a single tapered screw implant Bioinnovation Dental Brazil The implants were placed using the appropriate burs with a final master drill of 35 or 45 mm in diameter by one senior oral surgeon These implants were multi-threaded and their surfaces were both sandblasted and acid etched Of the 230 participants 172 received a single 5 x 10-mm implant and 58 received a 4 x 10-mm implant
For the higher torque range 90 - 200 Ncm the maximum IT was recorded with an electronic digital torque measuring device Tohnichi BTGE200CN-G Hitachi Japan while a different gauge Tohnichi BTG90CN-S Hitachi Japan was used for the lower torque range 10 - 90 Ncm All implants were placed at the crestal level and closed with a cover screw and the flap was then sutured with non-resorbable 40 nylon suture Resorba Germany
Pain levels were recorded at day 1 2 and 4 and at week 1 2 and 3 after surgery using visual analog scale VAS ranging from 0 no pain to 10 worst pain ever Implants were classified into 4 groups based on the IT value Low 60 implants 10-29 Ncm mean15 Ncm Regular 102 implants 30-50 Ncm mean42 Ncm High 47 implants 51-100 Ncm mean75 Ncm and Very high 21 implants 101-200 Ncm mean170 Ncm
Implant survival was assessed clinically and radiographically at 3 6 12 24 and 36 months The criteria for implant success according to Buser et al were no radiolucent zone around the implant confirmed individual implant stability and no suppuration pain or ongoing pathologic processes All implants that failed to fulfill these success criteria were regarded as failures
The effect of IT bone type implant location age gender and smoking was measured with regression analysis Kaplan-Meier survival analysis was performed to calculate the overall implant survival probabilities The level of statistical significance was set at p005
For the higher torque range 90 - 200 Ncm the maximum IT was recorded with an electronic digital torque measuring device Tohnichi BTGE200CN-G Hitachi Japan while a different gauge Tohnichi BTG90CN-S Hitachi Japan was used for the lower torque range 10 - 90 Ncm All implants were placed at the crestal level and closed with a cover screw and the flap was then sutured with non-resorbable 40 nylon suture Resorba Germany
Pain levels were recorded at day 1 2 and 4 and at week 1 2 and 3 after surgery using visual analog scale VAS ranging from 0 no pain to 10 worst pain ever Implants were classified into 4 groups based on the IT value Low 60 implants 10-29 Ncm mean15 Ncm Regular 102 implants 30-50 Ncm mean42 Ncm High 47 implants 51-100 Ncm mean75 Ncm and Very high 21 implants 101-200 Ncm mean170 Ncm
Implant survival was assessed clinically and radiographically at 3 6 12 24 and 36 months The criteria for implant success according to Buser et al were no radiolucent zone around the implant confirmed individual implant stability and no suppuration pain or ongoing pathologic processes All implants that failed to fulfill these success criteria were regarded as failures
The effect of IT bone type implant location age gender and smoking was measured with regression analysis Kaplan-Meier survival analysis was performed to calculate the overall implant survival probabilities The level of statistical significance was set at p005
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