Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378112
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
Extraction Socket Augmentation A Clinical Study
Sponsor:
Universidad de Granada
Organization:
Universidad de Granada
Study Overview
Official Title:
Extraction Socket Augmentation Using GTO vs Apatos A Randomized Controlled Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
GTO
Brief Summary:
Extraction socket preservation is defined as alveolar ridge preservation within the bone envelope remaining after tooth extraction meanwhile ridge augmentation is defined as increasing the volume of alveolar ridge beyond the bony envelope at the time of tooth extraction It is recommended to use in cases where extraction socket anatomy is intact In contrast definition extraction socket augmentation defines alveolar ridge restoration when bony walls of the socket are partly or completely lost In the case of severe loss 50 of the buccal bone plate preservation of hard tissue with a prolonged healing time before implant placement has been suggested
The null hypothesis of this experimental work states that i the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure i the two different bone graft materials exhibit similar histological and histomorphometric results Therefore the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation augmentation hard-tissue preservation
The null hypothesis of this experimental work states that i the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure i the two different bone graft materials exhibit similar histological and histomorphometric results Therefore the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation augmentation hard-tissue preservation
Detailed Description:
Patients needing teeth extraction and unitary implant placement will be recruited at the Dental School of the University of Granada Máster de Cirugía Bucal
Two study groups will be stated
Group 1 test group Guided bone regeneration procedure with GTO as bone graft and soft collagenated cortical membrane OsteoBiol Lamina Tecnoss srl as graft stabilizer
Group 2 control Guided bone regeneration procedure with Apatos Mix cortico-cancellous heterologous bone mix OsteoBiol Tecnoss srl as bone graft and soft collagenated cortical membrane OsteoBiol Lamina Tecnoss srl as graft stabilizer
All employed Materials are commercially available and are completely approved to be used in humans They are currently being used in dental practice in Europe USA and many other countries Eurofins Product Testing Italy Srl certifies that the manufacturers full quality assurance system is compliant with Annex II of 9342EEC Medical Devices Directive and subsequent amenaments and upgrades Certificate No EPT0477MDD1932091
Two study groups will be stated
Group 1 test group Guided bone regeneration procedure with GTO as bone graft and soft collagenated cortical membrane OsteoBiol Lamina Tecnoss srl as graft stabilizer
Group 2 control Guided bone regeneration procedure with Apatos Mix cortico-cancellous heterologous bone mix OsteoBiol Tecnoss srl as bone graft and soft collagenated cortical membrane OsteoBiol Lamina Tecnoss srl as graft stabilizer
All employed Materials are commercially available and are completely approved to be used in humans They are currently being used in dental practice in Europe USA and many other countries Eurofins Product Testing Italy Srl certifies that the manufacturers full quality assurance system is compliant with Annex II of 9342EEC Medical Devices Directive and subsequent amenaments and upgrades Certificate No EPT0477MDD1932091
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?:
False
Is an FDA AA801 Violation?:
None