Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408506
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-29
Brief Title:
In-patient Comparison of Immediately Loaded and Non-loaded Submerged and Transgingival Healed Implants Within 4 Months
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
In-patient Comparison of Immediately Loaded and Non-loaded Submerged and Transgingival Healed Implants Within 4 Months A Controlled Clinical Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 study involves 20 patients who require implant treatment for the edentulous lower jaw following specific inclusion and exclusion criteria Patients are drawn from the regular pool of those seeking implant therapy with no additional recruitment efforts
This study compares the effects of loaded and non-loaded dental implants Preoperative assessments include medical histories clinical and radiographic examinations of the jaw Participants are thoroughly informed about the study procedures and consent to participate through signed agreements They undergo preoperative diagnostics including panoramic X-rays to evaluate mandibular bone height and complete the OHIP-G 14 questionnaire to establish a baseline for their oral health-related quality of life
The implant placement involves standard outpatient surgical procedures under local anesthesia The implants used are CE-certified and are placed in predetermined positions in the edentulous region During the surgery intraoral scans and conventional impressions are performed Post-operative care includes oral rinses and radiographic assessments with follow-up visits scheduled for suture removal and further assessments using the visual analog scale for pain and swelling
The healing phase spans four months during which patients comfort and oral health are monitored through clinical examinations and additional questionnaires Follow-up after 4 months includes re-entry surgery and further radiographic evaluations and intraoral scans to assess the bones response around the implants Throughout the study adverse events and patient satisfaction are continuously documented
In the later stages regular follow-up visits for up to 24 months post-surgery to monitor implant stability and health through clinical and radiographic check-ups are performed
This study aims to document implant survival rates peri-implant bone regeneration assess biological and technical complications and evaluate patient satisfaction and quality of life throughout the implant process providing valuable data for future dental implant protocols
This study compares the effects of loaded and non-loaded dental implants Preoperative assessments include medical histories clinical and radiographic examinations of the jaw Participants are thoroughly informed about the study procedures and consent to participate through signed agreements They undergo preoperative diagnostics including panoramic X-rays to evaluate mandibular bone height and complete the OHIP-G 14 questionnaire to establish a baseline for their oral health-related quality of life
The implant placement involves standard outpatient surgical procedures under local anesthesia The implants used are CE-certified and are placed in predetermined positions in the edentulous region During the surgery intraoral scans and conventional impressions are performed Post-operative care includes oral rinses and radiographic assessments with follow-up visits scheduled for suture removal and further assessments using the visual analog scale for pain and swelling
The healing phase spans four months during which patients comfort and oral health are monitored through clinical examinations and additional questionnaires Follow-up after 4 months includes re-entry surgery and further radiographic evaluations and intraoral scans to assess the bones response around the implants Throughout the study adverse events and patient satisfaction are continuously documented
In the later stages regular follow-up visits for up to 24 months post-surgery to monitor implant stability and health through clinical and radiographic check-ups are performed
This study aims to document implant survival rates peri-implant bone regeneration assess biological and technical complications and evaluate patient satisfaction and quality of life throughout the implant process providing valuable data for future dental implant protocols
Detailed Description:
The clinical study conducted at the Dental School of the Medical University of Graz is designed to evaluate the effects and outcomes of loaded versus non-loaded dental implants in patients requiring treatment for an edentulous lower jaw This study includes 20 patients who meet specific inclusion and exclusion criteria and are recruited from the regular pool of patients at the facility without any special recruitment efforts
Study Overview The primary objective of this study is to compare the integration and performance of loaded and non-loaded dental implants Before the study procedures begin each participant undergoes a thorough preoperative evaluation which includes a complete medical history review and a detailed clinical and radiographic examination of the recipient site in the jaw These initial assessments are crucial for ensuring patient safety and suitability for the study
Informed Consent and Patient Information All participants receive detailed patient information leaflets that explain the studys purpose procedures potential risks and benefits This is followed by obtaining informed consent through a separate agreement form ensuring that all participants are fully aware and agreeable to the studys terms
Preoperative Procedures The preoperative phase includes radiological diagnostics such as panoramic x-rays to evaluate the mandibular bone and measure residual bone height Additionally participants complete the OHIP-G 14 questionnaire to gauge their oral health-related quality of life at baseline Intraoral photographs are also taken to document each patients initial condition
Surgical Procedure and Implant Placement The surgical procedures are performed under local anesthesia in a septic environment typical of outpatient settings Each patient rinses with a 02 chlorhexidine digluconate solution preoperatively A full-thickness flap is prepared and the bone is assessed for quality and quantity before implant placement The implants all CE-certified and of the same design are placed in six predetermined positions in the interforaminal region of the lower jaw
Postoperative Care and Assessments After implant placement excessive bleeding is controlled and the surgical sites condition is documented with intraoperative photographs and radiographs Probing to assess the peri-implant bone height is applied as well as intraoral scanning and conventional impressions are performed A panoramic x-ray and individual x-rays of the implants are taken immediately post-surgery The implants placed are either immediately loaded with a rotating gold bars or left to heal submerged or transgingival based on their predetermined positions Postoperative care includes prescribing antibiotics and anti-inflammatory medications as necessary and the administration of these drugs is meticulously documented
Follow-up Visits and Ongoing Evaluations The follow-up phase includes several visits where the integration of the prosthetic components to the loaded implants is assessed and sutures are removed The patients perceptions and acceptance of the implant and prosthetic fit are evaluated using a visual analog scale for pain and swelling The quality of life is continuously monitored through repeated administration of the OHIP-G 14 questionnaire
Healing Period A four-month healing period follows during which the implants are monitored through regular clinical checks These include sensitivity tests patient comfort tests and evaluations of general patient satisfaction
Secondary Surgery and Long-Term Follow-up A secondary surgery for exposing the remaining implants assessment of peri-implant bone remodeling using periodontal probes and intraoral scans as well as conventional impressions and further radiographic and clinical assessments are scheduled The study concludes with long-term follow-up visits which include professional tooth cleaning and routine check-ups to monitor the implants stability and the peri-implant conditions
Data Collection and Analysis Throughout the study data is collected on implant survival rates incidence of biological and technical complications and patient satisfaction Standardized periapical and panoramic radiographs are taken at various stages to serve as routine clinical assessments and a detailed scan analysis is performed to document bone quantity changes around the implants
Conclusion This comprehensive study aims to provide valuable insights into the comparative effectiveness of loaded and non-loaded implants contributing to the optimization of treatment protocols for dental implant therapy Through meticulous documentation and rigorous follow-up the study seeks to enhance understanding of the factors that influence implant success and patient satisfaction ultimately improving outcomes in dental implantology
Study Overview The primary objective of this study is to compare the integration and performance of loaded and non-loaded dental implants Before the study procedures begin each participant undergoes a thorough preoperative evaluation which includes a complete medical history review and a detailed clinical and radiographic examination of the recipient site in the jaw These initial assessments are crucial for ensuring patient safety and suitability for the study
Informed Consent and Patient Information All participants receive detailed patient information leaflets that explain the studys purpose procedures potential risks and benefits This is followed by obtaining informed consent through a separate agreement form ensuring that all participants are fully aware and agreeable to the studys terms
Preoperative Procedures The preoperative phase includes radiological diagnostics such as panoramic x-rays to evaluate the mandibular bone and measure residual bone height Additionally participants complete the OHIP-G 14 questionnaire to gauge their oral health-related quality of life at baseline Intraoral photographs are also taken to document each patients initial condition
Surgical Procedure and Implant Placement The surgical procedures are performed under local anesthesia in a septic environment typical of outpatient settings Each patient rinses with a 02 chlorhexidine digluconate solution preoperatively A full-thickness flap is prepared and the bone is assessed for quality and quantity before implant placement The implants all CE-certified and of the same design are placed in six predetermined positions in the interforaminal region of the lower jaw
Postoperative Care and Assessments After implant placement excessive bleeding is controlled and the surgical sites condition is documented with intraoperative photographs and radiographs Probing to assess the peri-implant bone height is applied as well as intraoral scanning and conventional impressions are performed A panoramic x-ray and individual x-rays of the implants are taken immediately post-surgery The implants placed are either immediately loaded with a rotating gold bars or left to heal submerged or transgingival based on their predetermined positions Postoperative care includes prescribing antibiotics and anti-inflammatory medications as necessary and the administration of these drugs is meticulously documented
Follow-up Visits and Ongoing Evaluations The follow-up phase includes several visits where the integration of the prosthetic components to the loaded implants is assessed and sutures are removed The patients perceptions and acceptance of the implant and prosthetic fit are evaluated using a visual analog scale for pain and swelling The quality of life is continuously monitored through repeated administration of the OHIP-G 14 questionnaire
Healing Period A four-month healing period follows during which the implants are monitored through regular clinical checks These include sensitivity tests patient comfort tests and evaluations of general patient satisfaction
Secondary Surgery and Long-Term Follow-up A secondary surgery for exposing the remaining implants assessment of peri-implant bone remodeling using periodontal probes and intraoral scans as well as conventional impressions and further radiographic and clinical assessments are scheduled The study concludes with long-term follow-up visits which include professional tooth cleaning and routine check-ups to monitor the implants stability and the peri-implant conditions
Data Collection and Analysis Throughout the study data is collected on implant survival rates incidence of biological and technical complications and patient satisfaction Standardized periapical and panoramic radiographs are taken at various stages to serve as routine clinical assessments and a detailed scan analysis is performed to document bone quantity changes around the implants
Conclusion This comprehensive study aims to provide valuable insights into the comparative effectiveness of loaded and non-loaded implants contributing to the optimization of treatment protocols for dental implant therapy Through meticulous documentation and rigorous follow-up the study seeks to enhance understanding of the factors that influence implant success and patient satisfaction ultimately improving outcomes in dental implantology
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