Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552715
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Pilot Study on the Effectiveness of a Flexible Hydroxyapatite-Based Composite for Jaw Bone Regeneration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Clinical Study on the Efficacy of a Flexible Hydroxyapatite-Based Composite for the Regeneration of Jaw Bone Defects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Flexi2024
Brief Summary:
Following a review of the scientific literature it was found that there are no clinical studies but only in vitro and in vivo studies which show promising results in terms of bone formation and integration However it is necessary to evaluate how well the regenerated bone maintains its structural integrity over time considering masticatory function and real-life biomechanics Factors such as mechanical load remodeling dynamics and interactions with surrounding tissues could influence the long-term stability of the regenerated bone Additionally another important aspect to study is the potential complications and adverse effects associated with the use of the flexible HAp-based composite
Detailed Description:
Following a review of the scientific literature it was found that there are no clinical studies but only in vitro and in vivo studies which show promising results in terms of bone formation and integration However it is necessary to evaluate how well the regenerated bone maintains its structural integrity over time considering masticatory function and biomechanics in real-life scenarios Factors such as mechanical load remodeling dynamics and interactions with surrounding tissues could influence the long-term stability of the regenerated bone Additionally another important aspect to study is the potential complications and adverse effects associated with the use of the flexible HAp-based composite
Study Objectives The primary objective is to evaluate the efficacy in terms of regenerated bone volume using the new flexible HAp-based composite in mixed bone defects of the jawbones
Primary Outcome Measures The volume of regenerated bone will be measured using CBCT scans before device placement immediately after the surgical procedure and at 8 months post-procedure The percentage of regenerated bone obtained compared to the initially planned augmentation ie the mean volume difference will be calculated before the surgical procedure immediately after device placement and at 8 months
Secondary Objectives These include evaluating intraoperative and postoperative complications occurring at the time of placement or after device placement assessing the conditions of peri-implant hard and soft tissues measuring overall patient satisfaction with the treatment analyzing the correlation between implant survival and various systemic and clinical patient factors and conducting a histological evaluation of vascularization and new bone formation in samples of regenerated bone taken during implant site preparation
Secondary Outcome Measures The condition of hard tissues will be assessed based on periapical intraoral radiographs For soft tissue conditions for each implant site peri-implant probing depth PPD bleeding on probing BOP presence of peri-implant plaque mPLI and the amount of keratinized gingiva will be considered at m3 m6 m9 and m12 from implant placement Any pathological events such as neurological lesions exposures infections inflammation fractures or loosening of prosthetic screws and prosthesis fractures reported in the clinical record during or after device placement and throughout the clinical follow-up will be evaluated as outcomes of intraoperative and postoperative complications at m3 m6 m9 and m12 from device placement To evaluate overall patient satisfaction two validated questionnaires will be analyzed the Oral Health Impact Profile OHIP-14 and a Patient Satisfaction questionnaire To assess the correlation between implant survival and certain systemic and clinical patient factors the following independent variables will be studied age gender smoking status jaw in which the implants were placed type of implant implant length implant diameter and compared with implant survival data Histological and histomorphometric analysis will be conducted on samples of regenerated bone collected during implant site preparation at the passage of the first preparation drill
Study Plan A total of 20 patients will be included in the study
Study Design This is a spontaneous prospective interventional clinical investigation with post-marketing medical device analysis enrolling patients with jaw bone atrophy at the Oral Surgery Unit of the Dental Clinic University of Bologna Collaboration with the laboratory at the University of Chieti-Pescara Department of Medical Oral and Biotechnological Sciences is planned Insurance will be covered by university funds for Oral Surgery
Study Start DateEnrollment After Ethics Committee approval and obtaining corporate clearance Prospective Period 1 year Total Study Duration 5 years including individual follow-ups and data processing
Study Population Inclusion Criteria Patients with partially edentulous and atrophic jaws requiring implant-prosthetic rehabilitation from 1 to 3 implants classified as Seibert Class II or III and needing a GBR bone regeneration intervention with defects not exceeding 7 mm in height Patients must be 18 years or older and must provide informed consent
Exclusion Criteria General contraindications to implant surgery Patients who have received head and neck irradiation of more than 70 Gray Immunocompromised and immunosuppressed patients Patients treated or under treatment with intravenous amino-bisphosphonates Patients with poor oral hygiene and motivation Uncontrolled diabetes Pregnancy or breastfeeding Drug or alcohol dependency Psychiatric conditions that contraindicate surgical treatment Limited mouth opening less than 35 cm between the two arches in the anterior region Patients with acute or chronic inflammationinfection at the implant site Patients referred solely for implant placement
Medical Device Under Study The study focuses on a bio-composite bone substitute based on hydroxyapatite Flexi-Oss Medical Inventi SA Lublin Poland This is a biphasic material comprising hydroxyapatite and a polymer component
Statistical Methods Sample Size The mean regenerated bone volume using a semi-occlusive CADCAM titanium device from a previous study was 1524 mm³ Considering an estimate of 1380 mm³ of regenerated bone using the hydroxyapatite-based bio-composite bone substitute with a standard deviation of 200 mm³ a significance level alpha of 005 and a statistical power of 80 using the two-sided Z test it was determined that 16 patients need to be enrolled Considering a potential dropout rate of 20 the number of patients to be included in the study has been increased to 20
Study Objectives The primary objective is to evaluate the efficacy in terms of regenerated bone volume using the new flexible HAp-based composite in mixed bone defects of the jawbones
Primary Outcome Measures The volume of regenerated bone will be measured using CBCT scans before device placement immediately after the surgical procedure and at 8 months post-procedure The percentage of regenerated bone obtained compared to the initially planned augmentation ie the mean volume difference will be calculated before the surgical procedure immediately after device placement and at 8 months
Secondary Objectives These include evaluating intraoperative and postoperative complications occurring at the time of placement or after device placement assessing the conditions of peri-implant hard and soft tissues measuring overall patient satisfaction with the treatment analyzing the correlation between implant survival and various systemic and clinical patient factors and conducting a histological evaluation of vascularization and new bone formation in samples of regenerated bone taken during implant site preparation
Secondary Outcome Measures The condition of hard tissues will be assessed based on periapical intraoral radiographs For soft tissue conditions for each implant site peri-implant probing depth PPD bleeding on probing BOP presence of peri-implant plaque mPLI and the amount of keratinized gingiva will be considered at m3 m6 m9 and m12 from implant placement Any pathological events such as neurological lesions exposures infections inflammation fractures or loosening of prosthetic screws and prosthesis fractures reported in the clinical record during or after device placement and throughout the clinical follow-up will be evaluated as outcomes of intraoperative and postoperative complications at m3 m6 m9 and m12 from device placement To evaluate overall patient satisfaction two validated questionnaires will be analyzed the Oral Health Impact Profile OHIP-14 and a Patient Satisfaction questionnaire To assess the correlation between implant survival and certain systemic and clinical patient factors the following independent variables will be studied age gender smoking status jaw in which the implants were placed type of implant implant length implant diameter and compared with implant survival data Histological and histomorphometric analysis will be conducted on samples of regenerated bone collected during implant site preparation at the passage of the first preparation drill
Study Plan A total of 20 patients will be included in the study
Study Design This is a spontaneous prospective interventional clinical investigation with post-marketing medical device analysis enrolling patients with jaw bone atrophy at the Oral Surgery Unit of the Dental Clinic University of Bologna Collaboration with the laboratory at the University of Chieti-Pescara Department of Medical Oral and Biotechnological Sciences is planned Insurance will be covered by university funds for Oral Surgery
Study Start DateEnrollment After Ethics Committee approval and obtaining corporate clearance Prospective Period 1 year Total Study Duration 5 years including individual follow-ups and data processing
Study Population Inclusion Criteria Patients with partially edentulous and atrophic jaws requiring implant-prosthetic rehabilitation from 1 to 3 implants classified as Seibert Class II or III and needing a GBR bone regeneration intervention with defects not exceeding 7 mm in height Patients must be 18 years or older and must provide informed consent
Exclusion Criteria General contraindications to implant surgery Patients who have received head and neck irradiation of more than 70 Gray Immunocompromised and immunosuppressed patients Patients treated or under treatment with intravenous amino-bisphosphonates Patients with poor oral hygiene and motivation Uncontrolled diabetes Pregnancy or breastfeeding Drug or alcohol dependency Psychiatric conditions that contraindicate surgical treatment Limited mouth opening less than 35 cm between the two arches in the anterior region Patients with acute or chronic inflammationinfection at the implant site Patients referred solely for implant placement
Medical Device Under Study The study focuses on a bio-composite bone substitute based on hydroxyapatite Flexi-Oss Medical Inventi SA Lublin Poland This is a biphasic material comprising hydroxyapatite and a polymer component
Statistical Methods Sample Size The mean regenerated bone volume using a semi-occlusive CADCAM titanium device from a previous study was 1524 mm³ Considering an estimate of 1380 mm³ of regenerated bone using the hydroxyapatite-based bio-composite bone substitute with a standard deviation of 200 mm³ a significance level alpha of 005 and a statistical power of 80 using the two-sided Z test it was determined that 16 patients need to be enrolled Considering a potential dropout rate of 20 the number of patients to be included in the study has been increased to 20
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