Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305000
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-05
Brief Title:
Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis
Sponsor:
Biruni University
Organization:
Biruni University
Study Overview
Official Title:
Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters The main question it aims to answer is
Would increasing the width of the keratinized mucosa with free gingival graft FGG in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone
Our study consists of 4 groups
Peri-implant healthy group with sufficient keratinized mucosa 2mm n16 peri-implant mucositis group with sufficient keratinized mucosa n16 peri-implant mucositis group with insufficient keratinized mucosa 2mm receiving only non-surgical treatment n16 peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment n16 Clinical and biochemical measurements will be recorded at the baseline 1st month 4th month and 7th month of the study Peri-implant crevicular fluid samples will be collected at baseline 1st month 4th month and 7th month IL-1β RANKL OPG levels and RANKLOPG ratio will be analyzed from collected samples
Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis
Would increasing the width of the keratinized mucosa with free gingival graft FGG in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone
Our study consists of 4 groups
Peri-implant healthy group with sufficient keratinized mucosa 2mm n16 peri-implant mucositis group with sufficient keratinized mucosa n16 peri-implant mucositis group with insufficient keratinized mucosa 2mm receiving only non-surgical treatment n16 peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment n16 Clinical and biochemical measurements will be recorded at the baseline 1st month 4th month and 7th month of the study Peri-implant crevicular fluid samples will be collected at baseline 1st month 4th month and 7th month IL-1β RANKL OPG levels and RANKLOPG ratio will be analyzed from collected samples
Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis
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