Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632548
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Retention of Three Different Types of Telescopic Attachments
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retention of Three Different Secondary Copings in Telescopic Attchments Used to Stabilize Implant Retained Mandibular Overdenture a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Overdenture
Brief Summary:
This study was conducted on thirty patients These patients were divided into three groups in a random manner to compare the retention forces between three different types of secondary crowns used to stabilize two implant mandibular overdentures in all groups the primary coping was fabricated from milled titanium while the secondary coping was milled titanium in first group 3D printed cobalt chromium in the second group and milled poly ether ketone ketone in the third group the retention forces was measured using forcemeter immediately after insertion and after 36 months
Detailed Description:
A thirty edentulous patients Was selected from outpatient clinic of
Exclusion criteria
1 systemic and metabolic disorders that may complicate osseointegration
2 Patients receiving bisphosphonates
3 patients receiving radiotherapy The patients was assigned into three groups using balanced randomly Patients was randomly allocated into one of three groups using random numbers generated using Excel program
Group I included patients who received 2 implants and telescopic overdentures with milled titanium primary and secondary coping Group II included patients who received telescopic overdentures with milled titanium primary coping and three dimensionally printed secondary coping GroupIII patients recived milled titanium primary coping and poly ether ketone ketone secondary copings PEKK secondary coping All patients signed an informed consent
Surgical and prosthetic protocols
A radiographic stent with gutta percha markers at the canine region was fabricated and the patient was instructed to wear it during cone beam radiographic evaluation to evaluate proposed implant sites regarding bone height and thickness and approximation to vital structures mental foramen
Radiographic template was converted to surgical template
The two implants was inserted nearly parallel as possible If inclination of the implants was inevitable buccally or lingually due to mandibular concavities the inclination was compensated later during design of primary copings
The implants was inserted in the canine region with two steps surgical protocol After three months of the insertion and osseointegration implants was exposed and healing abutments was inserted after gingival healing implant level impression will be taken
The metallic primary coping was milled with 2-degree convergence for all cases while the second coping was milled titanium or 3D printed cobalt chromium or milled PEKK according the patient group
the primary copings was screwed to the implants and the secondary coping pick up was done and patient was instructed to follow oral hygiene measures and was scheduled for periodic follow up every 3 months
Evaluation of overdenture retention
Force meter device was used to measure the retention of the mandibular overdenture in Newton
The patient was seated on upright position and asked to open his mouth until the occlusal surface of the lower denture is parallel to the floor and the maximum dislodging force to remove the denture is recorded using digital forcemeter
Measurement of retention forces was made immediately after overdenture insertion and repeated at 369and 12 months after insertion after by independent dental personnel blinded to treatment groups
Exclusion criteria
1 systemic and metabolic disorders that may complicate osseointegration
2 Patients receiving bisphosphonates
3 patients receiving radiotherapy The patients was assigned into three groups using balanced randomly Patients was randomly allocated into one of three groups using random numbers generated using Excel program
Group I included patients who received 2 implants and telescopic overdentures with milled titanium primary and secondary coping Group II included patients who received telescopic overdentures with milled titanium primary coping and three dimensionally printed secondary coping GroupIII patients recived milled titanium primary coping and poly ether ketone ketone secondary copings PEKK secondary coping All patients signed an informed consent
Surgical and prosthetic protocols
A radiographic stent with gutta percha markers at the canine region was fabricated and the patient was instructed to wear it during cone beam radiographic evaluation to evaluate proposed implant sites regarding bone height and thickness and approximation to vital structures mental foramen
Radiographic template was converted to surgical template
The two implants was inserted nearly parallel as possible If inclination of the implants was inevitable buccally or lingually due to mandibular concavities the inclination was compensated later during design of primary copings
The implants was inserted in the canine region with two steps surgical protocol After three months of the insertion and osseointegration implants was exposed and healing abutments was inserted after gingival healing implant level impression will be taken
The metallic primary coping was milled with 2-degree convergence for all cases while the second coping was milled titanium or 3D printed cobalt chromium or milled PEKK according the patient group
the primary copings was screwed to the implants and the secondary coping pick up was done and patient was instructed to follow oral hygiene measures and was scheduled for periodic follow up every 3 months
Evaluation of overdenture retention
Force meter device was used to measure the retention of the mandibular overdenture in Newton
The patient was seated on upright position and asked to open his mouth until the occlusal surface of the lower denture is parallel to the floor and the maximum dislodging force to remove the denture is recorded using digital forcemeter
Measurement of retention forces was made immediately after overdenture insertion and repeated at 369and 12 months after insertion after by independent dental personnel blinded to treatment groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None