Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430268
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-21
Brief Title:
Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants
Sponsor:
Andrea Ravida
Organization:
University of Pittsburgh
Study Overview
Official Title:
Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants A Randomized Clinical Trial
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 will compare 2 methods to clean contaminated implant surfaces air-polishing device versus titanium curette Both of these methods will be used in the non-surgical and surgical setting followed by implant removal Then in-vitro analysis to assess the efficacy of surface decontamination will be performed
Detailed Description:
A screening visit will be performed to determine the elegibility of the individuals to participate in the study Information related to the target implant eg brand material surface dimensions time of function history of treatment of peri-implantitis and reconstruction eg cemented or screwed prosthesis single multi-unit or full-arch will be collected Intra-oral radiographs will be obtained or exported from patients dental records and the marginal bone level MBL will be measured at the mesial and distal aspects of the implants by one calibrated investigator using an image analysis software Image J National Institutes of Health Bethesda MD USA The anatomy of the bone defect will be determined
Randomization will be performed in a stratified manner in sets of 10 implants by a computer software to obtain equally balanced groups based on implant characteristics site brand design A researcher not involved in the clinical interventions will be responsible for randomization
At the day of implant removal a single calibrated examiner will assess the following parameters at six sites around each experimental implant using an UNC 15 periodontal probe 1 Plaque accumulation using the modified plaque index mPI 2 Probing depth mm 3 Bleeding on probing using the modified gingival index mGI 4 Suppuration 5 Recession mm The width of keratinized mucosa KM will be obtained in the mid-buccal and mid-lingal aspect of the implants mm A standard tessellation language STL file of the arch of interest using an intraoral optical scanner Trios 3 3Shape Denmark will be obtained
Surface decontamination protocols
All cleaning procedures will be performed without the suprastructures A notch will be performed on the buccal side of all implant shoulders with the aid of a bur in order to distinguish the different implant surfaces during the microbiological and biocompatibility analysis phases
Following local anesthesia implants will be randomly assigned to the following study groups
1 Non-surgical decontamination with titanium curettes prior to implant removal n 20
2 Non-surgical decontamination with erythritol powder prior to implant removal n 20
3 Surgical decontamination with titanium curettes prior to implant removal n 20
4 Surgical decontamination with erythritol powder prior to implant removal n 20
5 No decontamination prior to implant removal n10
In the surgical groups intra-sulcular and if necessary vertical releasing incisions will be performed Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed
All giant visible calculus will be removed with an ultrasonic tip in advance without touching the implant surface directly Copious irrigation with saline will be performed in both groups prior to implant decontamination All implants will be cleaned by the same operator with the aid of dental surgical loupes The time needed for the operator to consider the implant surface clean will be recorded
Titanium curettes Hu-Friedy Chicago Illinois USA will be used for supra and submucosal around the implants
Air-polishing Airflow Prophylaxis Master EMS Nyon Switzerland will be carried out with AIR-FLOW powder PLUS EMS containing erythritol sugar alcohol 14 μm amorphous silica and 03 chlorhexidine The device will be adjusted to a power setting of 5 bar static pressure and a maximum level of irrigation with water
Non-surgical group The supramucosal implant surfaces will be cleaned with the Airflow handpiece while for the submucosal areas a Perioflow handpiece and nozzle for submucosal instrumentation will be used The nozzle will be changed after cleaning each implant
Surgical group The Airflow handpiece will be moved in a horizontal direction along implant threads from an apical to a coronal position The angulation of the handpiece and working distance will not be standardized as they may vary according to the area being cleaned
Implant removal
Once the decontamination procedure has been completed all the implants will be explanted with the aid of a reverse torque device Implant Removal Kit Zimmer Biomet no trephines will be used During the procedure care will be taken to avoid damage to the implant and its surface The retrieved implants will be immersed in a transport medium Dulbeccos Modified Eagle Medium and stored in sterile plastic vials at 4C until further analysis
In all study groups the explanted sites will be again curetted and the soft tissues will be sutured with interrupted or crossed sutures Subjects will receive detailed verbal and written postoperative instructions as well as a prescription for anti-inflammatory medication ibuprofen 600mg for 3-5 days as needed for pain control Patients will be instructed to rinse gently with 012 chlorhexidine twice daily for 1 week Sutures will be removed after 2 weeks
Subsequently a second randomization will take place to direct each implant n 10 in each decontamination group for microbiologicalelementary composition analysis and biocompatibility analysis In-vitro analysis post surface decontamination includes assessing the cleaning efficacy microbiological analysis biocompatibility analysis including cultivation of cells RNA extraction Reverse Transcription RT and Real-Time RT-Polymerase Chain Reaction Real-Time RT-PCR and elementary composition analysis including implant surface degradation corrosion performance and atomic composition
Randomization will be performed in a stratified manner in sets of 10 implants by a computer software to obtain equally balanced groups based on implant characteristics site brand design A researcher not involved in the clinical interventions will be responsible for randomization
At the day of implant removal a single calibrated examiner will assess the following parameters at six sites around each experimental implant using an UNC 15 periodontal probe 1 Plaque accumulation using the modified plaque index mPI 2 Probing depth mm 3 Bleeding on probing using the modified gingival index mGI 4 Suppuration 5 Recession mm The width of keratinized mucosa KM will be obtained in the mid-buccal and mid-lingal aspect of the implants mm A standard tessellation language STL file of the arch of interest using an intraoral optical scanner Trios 3 3Shape Denmark will be obtained
Surface decontamination protocols
All cleaning procedures will be performed without the suprastructures A notch will be performed on the buccal side of all implant shoulders with the aid of a bur in order to distinguish the different implant surfaces during the microbiological and biocompatibility analysis phases
Following local anesthesia implants will be randomly assigned to the following study groups
1 Non-surgical decontamination with titanium curettes prior to implant removal n 20
2 Non-surgical decontamination with erythritol powder prior to implant removal n 20
3 Surgical decontamination with titanium curettes prior to implant removal n 20
4 Surgical decontamination with erythritol powder prior to implant removal n 20
5 No decontamination prior to implant removal n10
In the surgical groups intra-sulcular and if necessary vertical releasing incisions will be performed Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed
All giant visible calculus will be removed with an ultrasonic tip in advance without touching the implant surface directly Copious irrigation with saline will be performed in both groups prior to implant decontamination All implants will be cleaned by the same operator with the aid of dental surgical loupes The time needed for the operator to consider the implant surface clean will be recorded
Titanium curettes Hu-Friedy Chicago Illinois USA will be used for supra and submucosal around the implants
Air-polishing Airflow Prophylaxis Master EMS Nyon Switzerland will be carried out with AIR-FLOW powder PLUS EMS containing erythritol sugar alcohol 14 μm amorphous silica and 03 chlorhexidine The device will be adjusted to a power setting of 5 bar static pressure and a maximum level of irrigation with water
Non-surgical group The supramucosal implant surfaces will be cleaned with the Airflow handpiece while for the submucosal areas a Perioflow handpiece and nozzle for submucosal instrumentation will be used The nozzle will be changed after cleaning each implant
Surgical group The Airflow handpiece will be moved in a horizontal direction along implant threads from an apical to a coronal position The angulation of the handpiece and working distance will not be standardized as they may vary according to the area being cleaned
Implant removal
Once the decontamination procedure has been completed all the implants will be explanted with the aid of a reverse torque device Implant Removal Kit Zimmer Biomet no trephines will be used During the procedure care will be taken to avoid damage to the implant and its surface The retrieved implants will be immersed in a transport medium Dulbeccos Modified Eagle Medium and stored in sterile plastic vials at 4C until further analysis
In all study groups the explanted sites will be again curetted and the soft tissues will be sutured with interrupted or crossed sutures Subjects will receive detailed verbal and written postoperative instructions as well as a prescription for anti-inflammatory medication ibuprofen 600mg for 3-5 days as needed for pain control Patients will be instructed to rinse gently with 012 chlorhexidine twice daily for 1 week Sutures will be removed after 2 weeks
Subsequently a second randomization will take place to direct each implant n 10 in each decontamination group for microbiologicalelementary composition analysis and biocompatibility analysis In-vitro analysis post surface decontamination includes assessing the cleaning efficacy microbiological analysis biocompatibility analysis including cultivation of cells RNA extraction Reverse Transcription RT and Real-Time RT-Polymerase Chain Reaction Real-Time RT-PCR and elementary composition analysis including implant surface degradation corrosion performance and atomic composition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None