Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392256
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-26
Brief Title:
Effect of Free Gingival Grafting on Peri-implant Health
Sponsor:
Gazi University
Organization:
Gazi University
Study Overview
Official Title:
The Influence of Soft Tissue Phenotype Modification Following Free Gingival Grafting on the Treatment of Peri-implant Mucositis
Status:
ACTIVE_NOT_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:
The goal of this randomized-controlled clinical study is to investigate the impact of soft tissue phenotype modification following free gingival grafting FGG in addition to the non-surgical mechanical therapy of peri-implant mucositis PM with keratinized mucosa width KMW 2 mm over a 6-month follow-up period Therefore the following questions related to the study are raised
Does soft tissue modification following free gingival grafting around the implants in addition to non-surgical mechanical therapy of PM affect the complete disease resolution
Does the presence of KMW 2 mm around the implants exhibit similar outcomes compared to the sites with sufficient KMW ie 2 mm for professional mechanical plaque removal
Patients who apply to the Department of Periodontology Faculty of Dentistry Gazi University are systemically healthy have implant-supported fixed restorations installed at least one year prior to their enrollment and are diagnosed with PM on these implants will be selected for the study Patients with KMW 2 mm at the respective implant sites will be treated with non-surgical mechanical treatment combined with soft tissue augmentation with FGG or non-surgical mechanical treatment alone As a positive control group those who apply to the same department have implants in function as noted during routine annual maintenance appointments and are diagnosed as healthy will be selected
Does soft tissue modification following free gingival grafting around the implants in addition to non-surgical mechanical therapy of PM affect the complete disease resolution
Does the presence of KMW 2 mm around the implants exhibit similar outcomes compared to the sites with sufficient KMW ie 2 mm for professional mechanical plaque removal
Patients who apply to the Department of Periodontology Faculty of Dentistry Gazi University are systemically healthy have implant-supported fixed restorations installed at least one year prior to their enrollment and are diagnosed with PM on these implants will be selected for the study Patients with KMW 2 mm at the respective implant sites will be treated with non-surgical mechanical treatment combined with soft tissue augmentation with FGG or non-surgical mechanical treatment alone As a positive control group those who apply to the same department have implants in function as noted during routine annual maintenance appointments and are diagnosed as healthy will be selected
Detailed Description:
The primary goal of treating peri-implant mucositis PM is to disturb the dental implant biofilm and resolve inflammatory conditions This aims to achieve treatment success or complete disease resolution preventing its progression to peri-implantitis Indeed regardless of the non-surgical mechanicalphysical instrumentation approaches and despite noticeable clinical improvements none of the existing procedures would result in complete disease resolution ie absence of bleeding on probing BOP in peri-implant mucositis Taking this into account the execution of interventions targeted at managing modifiable risk factors plays a pivotal role in maintaining peri-implant health
Despite the increasing evidence documenting that implant sites exhibiting either a lacking or a reduced keratinized mucosa KM of 2 mm demonstrate difficulties in eliminating bacterial biofilm leading to inflammation around the soft tissue the requirement for a minimum peri-implant KM width KMW to avoid peri-implant diseases has been a highly debated topic Indeed KM augmentation at implant sites with a reduced KMW has been reported to be associated with statistically significant lower plaque and gingival scores as well as peri-implant probing depths PPD when compared with non-augmented sites However there is no study evaluating primarily the effect of KM augmentation on maintaining peri-implant health and preventing peri-implant diseases
Therefore the aim of this study is to investigate the impact of soft tissue phenotype modification following free gingival grafting in addition to the non-surgical submarginal instrumentation of peri-implant mucositis over a 6-month follow-up period
Despite the increasing evidence documenting that implant sites exhibiting either a lacking or a reduced keratinized mucosa KM of 2 mm demonstrate difficulties in eliminating bacterial biofilm leading to inflammation around the soft tissue the requirement for a minimum peri-implant KM width KMW to avoid peri-implant diseases has been a highly debated topic Indeed KM augmentation at implant sites with a reduced KMW has been reported to be associated with statistically significant lower plaque and gingival scores as well as peri-implant probing depths PPD when compared with non-augmented sites However there is no study evaluating primarily the effect of KM augmentation on maintaining peri-implant health and preventing peri-implant diseases
Therefore the aim of this study is to investigate the impact of soft tissue phenotype modification following free gingival grafting in addition to the non-surgical submarginal instrumentation of peri-implant mucositis over a 6-month follow-up period
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