Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404944
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-04-29
Brief Title:
Using of Implants With a Sloped Platform Edge
Sponsor:
IM Sechenov First Moscow State Medical University
Organization:
IM Sechenov First Moscow State Medical University
Study Overview
Official Title:
The Use of Implants With a Sloped Platform Edge in Patients With Ridge Atrophy
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:
An interventional prospective randomized clinical trial RCT was conducted in parallel groups The sample size consisted of 30 patients who were randomly assigned to two groups based on the type of surgical intervention The first group received implants with a sloped edge platform Dentsply Sirona CIS ASTRA TECH Implant System registered in Russia on 21122019 No РЗН 20153214 The second group received implants with bone grafting The assessment in the postoperative period included evaluating the condition of the soft tissues bone resorption number of analgesics duration of the operation edema keratinized mucosa width implant stability quotient pain severity and quality of life
Detailed Description:
The research aimed to compare the clinical and radiological assessment of soft and hard tissues surrounding implants with a sloped edge platform Thirty patients with alveolar ridge atrophy were examined at the Department of Surgical Dentistry of the EV Borovsky Institute of Dentistry IM Sechenov First Moscow State Medical University These patients displayed a deficiency in hard tissue width necessitating augmentation for dental implant placement Patients were randomly divided into two groups based on treatment methods The first group received implants with a sloped edge platform Dentsply Sirona CIS ASTRA TECH Implant System registered in Russia on 21122019 No РЗН 20153214 The second group underwent treatment with implants of a standard design combined with bone grafting Gender and age characteristics were matched between the groups for comparability
Patients in the first group were implanted with sloped edge platform implants while the second group received implants with a different design Dentsply Sirona CIS ASTRA TECH Implant System registered in Russia on 21122019 No РЗН 20153214 incorporating guided bone regeneration All groups underwent muco-periosteal flap mobilization followed by wound closure without tension using simple interrupted sutures
In the early postoperative phase antibacterial and anti-inflammatory therapy was combined with the use of local antiseptics for daily care Implant uncovering with healing abutment installation occurred 4-6 months post-intervention The postoperative assessments included evaluating soft tissue condition bone resorption analgesic consumption operation duration edema keratinized mucosa width implant stability quotient pain severity and quality of life
Patients in the first group were implanted with sloped edge platform implants while the second group received implants with a different design Dentsply Sirona CIS ASTRA TECH Implant System registered in Russia on 21122019 No РЗН 20153214 incorporating guided bone regeneration All groups underwent muco-periosteal flap mobilization followed by wound closure without tension using simple interrupted sutures
In the early postoperative phase antibacterial and anti-inflammatory therapy was combined with the use of local antiseptics for daily care Implant uncovering with healing abutment installation occurred 4-6 months post-intervention The postoperative assessments included evaluating soft tissue condition bone resorption analgesic consumption operation duration edema keratinized mucosa width implant stability quotient pain severity and quality of life
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