Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637930
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Comparing Cobalt-Chromium Versus PEEK Secondary Telescopic Crowns on Implant Retained Mandibular Overdenture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical and Radiographic Evaluations of Implant Retained Mandibular Overdenture Using CADCAM Fabricated Telescopic Crown Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-10
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:
None
Brief Summary:
The aim of this randomized clinical trial was to compare
I- The clinical behavior of implant retained removable overdenture using telescopic retention system fabricated using CADCAM techniques where the effects of the different material combinations were examined in regard to
1 Retention of the mandibular over-denture
2 Plaque accumulation presence of calculus bleeding tendency health of peri-implant mucosa and probing depth
II - The radiographic behavior regarding marginal bone level and bone density
I- The clinical behavior of implant retained removable overdenture using telescopic retention system fabricated using CADCAM techniques where the effects of the different material combinations were examined in regard to
1 Retention of the mandibular over-denture
2 Plaque accumulation presence of calculus bleeding tendency health of peri-implant mucosa and probing depth
II - The radiographic behavior regarding marginal bone level and bone density
Detailed Description:
This study compared implant-retained telescopic mandibular overdentures reinforced with milled metal framework Co-Cr and milled polymer PEEK in terms of retention periimplant mucosal health and radiographic changes in twelve patients
Initially all patients received conventional complete dentures A CBCT was conducted prior to the implant surgical phase using a radiographic stent Two implants were inserted interforaminally using a flapless method The implants were then left for three months to allow for osseointegration and the patients were instructed to wear their complete dentures during the healing process
Following the osseointegration period the prosthetic phase began with all patients obtaining primary crowns constructed from titanium alloys The patients were then randomly divided into two groups 6 patients in each group Group A received a COCR framework that included secondary crowns while group B received a PEEK framework and secondary crowns
Retention was tested for each group baseline 6 months 9 months and 12 months using a digital force gauge The pulling force gradually increased until the denture was dislodged The retentive force was measured during the initial separation of the telescopic crown
Soft tissue conditions was assessed using single coded probe for each group baseline 6 months 9 months and 12 monthsBleeding tendency on probing plaque accumulation calculus deposition perimplant mucosal health were the parameters for each group evaluation
While the radiographic assessment was performed for each group baseline 6months 9 months and12 months using digital periapical radiographs by the means of XCP instrument and digital sensor The marginal bone level was measured by evaluating the difference of bone level at the neck of the implant The bone density was evaluated at three areas surrounding the implants
Initially all patients received conventional complete dentures A CBCT was conducted prior to the implant surgical phase using a radiographic stent Two implants were inserted interforaminally using a flapless method The implants were then left for three months to allow for osseointegration and the patients were instructed to wear their complete dentures during the healing process
Following the osseointegration period the prosthetic phase began with all patients obtaining primary crowns constructed from titanium alloys The patients were then randomly divided into two groups 6 patients in each group Group A received a COCR framework that included secondary crowns while group B received a PEEK framework and secondary crowns
Retention was tested for each group baseline 6 months 9 months and 12 months using a digital force gauge The pulling force gradually increased until the denture was dislodged The retentive force was measured during the initial separation of the telescopic crown
Soft tissue conditions was assessed using single coded probe for each group baseline 6 months 9 months and 12 monthsBleeding tendency on probing plaque accumulation calculus deposition perimplant mucosal health were the parameters for each group evaluation
While the radiographic assessment was performed for each group baseline 6months 9 months and12 months using digital periapical radiographs by the means of XCP instrument and digital sensor The marginal bone level was measured by evaluating the difference of bone level at the neck of the implant The bone density was evaluated at three areas surrounding the implants
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