Ignite Creation Date:
2024-10-25 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614426
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Surgical Treatment of Peri-implantitis Defects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Electrolysis Decontamination with or Without Leukocyteplatelet Rich Fibrin L-PRF in the Surgical Treatment of Peri-implantitis Defects a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 study is to evaluate the efficacy of implant surface decontamination using electrolysis cleaning system And to evaluate the adjunctive use of L-PRF in promoting soft tissue healing and long-term stability of the peri-implant marginal bone in the surgical treatment of peri-implantitis
Detailed Description:
Research design
Prospective in which participants will be recruited and then followed up throughout a specified period of time
Randomized parallel designed concurrent controlled trial with participants randomly allocated to either control or test groups
Single-blinded as the outcome accessors will be blinded to the intervention
Materials and Methods
Patients attending Dubai Dental Hospital and requiring treatment of peri-implantitis will be invited to take part in this randomized controlled trial based on the following inclusion and exclusion criteria
Inclusion criteria
Aged 18 or over
Require treatment of peri-implantitis defined as the presence of bleeding andor suppuration on gentle probing probing depths of 6 mm presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling
Screw retained implant crown
Good compliance and commitment to attend follow-up review appointments
Willing to provide informed consent
Exclusion criteria
History of surgical therapy of peri-implantitis
Peri-implant defects indicated for regenerative procedure ie contained bony defect
Cement retained implant crown
Systemiclocal antibiotics during the previous 6 months
Bone metabolic disease andor taking medications that affect bone metabolism
History of malignancy radiotherapy or chemotherapy
Pregnant or lactating women
Smokers
The study will be conducted following the ethical standards of the Declaration of Helsinki in 1975 as revised in 2013 and the CONSORT statement will be used as a guideline in reporting this study
Randomization allocation concealment and blinding
The participants will be randomly allocated to three equally sized groups using computer-generated numbers
Control group C Conventional open flap debridement Test group 1 T1 Open flap debridement using GalvoSurge - Straumann Test group 2 T2 Open flap debridement using GalvoSurge - Straumann combined with L-PRF application
Prospective in which participants will be recruited and then followed up throughout a specified period of time
Randomized parallel designed concurrent controlled trial with participants randomly allocated to either control or test groups
Single-blinded as the outcome accessors will be blinded to the intervention
Materials and Methods
Patients attending Dubai Dental Hospital and requiring treatment of peri-implantitis will be invited to take part in this randomized controlled trial based on the following inclusion and exclusion criteria
Inclusion criteria
Aged 18 or over
Require treatment of peri-implantitis defined as the presence of bleeding andor suppuration on gentle probing probing depths of 6 mm presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling
Screw retained implant crown
Good compliance and commitment to attend follow-up review appointments
Willing to provide informed consent
Exclusion criteria
History of surgical therapy of peri-implantitis
Peri-implant defects indicated for regenerative procedure ie contained bony defect
Cement retained implant crown
Systemiclocal antibiotics during the previous 6 months
Bone metabolic disease andor taking medications that affect bone metabolism
History of malignancy radiotherapy or chemotherapy
Pregnant or lactating women
Smokers
The study will be conducted following the ethical standards of the Declaration of Helsinki in 1975 as revised in 2013 and the CONSORT statement will be used as a guideline in reporting this study
Randomization allocation concealment and blinding
The participants will be randomly allocated to three equally sized groups using computer-generated numbers
Control group C Conventional open flap debridement Test group 1 T1 Open flap debridement using GalvoSurge - Straumann Test group 2 T2 Open flap debridement using GalvoSurge - Straumann combined with L-PRF application
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