Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382337
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-10
Brief Title:
Immediate Dental Implants in The Upper Anterior Region
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Maxillary Anterior Teeth Replacement With Immediate Dental Implants Utilizing Vestibular Socket Therapy Versus Ice Cream Cone Technique
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically
Detailed Description:
Tooth loss is the endpoint of oral diseases such as dental caries and periodontitis and reflects the utilization of dental services during a lifetime
The incidence of tooth loss has significantly declined at the global levels However tooth loss and oral diseases are still a major public health concern worldwide
In the anterior region the common reason for tooth loss is due to traumatic injury or congenital anomaly loss of a single tooth may cause functional and esthetic deficits to the patient Tooth extraction usually accompanies alveolar ridge resorption along with loss of preexisting tissue morphology
There is a new developed a post-extraction fresh socket classification system as follows Type 1 The facial soft tissue and buccal plate of bone are at normal levels in relation to the cement enamel junction of the pre-extracted tooth and remain intact post extraction
Type 2 Facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth Type 3 The facial soft tissue and the buccal plate of the bone are both markedly reduced after tooth extraction This classification enabled ordering and classifying of post-extraction sockets
A recently published sub-classification of type 2 now allows even greater clarity to plan regeneration Type 2 A Absence of the coronal one-third of labial bone plate of the extraction socket 5mm to 6mm from the free gingival margin Type 2 B Absence of the middle to coronal two thirds of the labial bone plate of the extraction socket approximately 7mm to 9mm from the free gingival margin
Type 2 C Absence of the apical one-third of the labial bone plate of the extraction socket 10 mm or more from the free gingival margin For the management of socket defects after extraction numerous techniques have been developed to allow for optimum esthetic and functional outcomes Among those techniques are ice cream cone technique described by Deniss Tarnow and the more recently introduce vestibular socket therapy VST introduced by Abd Salam Elaskary Deniss Tarnow invented his technique ice cream cone to augment the socket with buccal dehiscence in this technique socket preservation was done using a collagen membrane shaped into an ice cream cone and placing it inside the extraction socket to cover the dehiscence site and the socket occlusally at the same time
The regeneration of the buccal plate using the ice cream cone technique was possible in the dental extraction and by the immediate implant in an infected site in a case report of a 53 years old patient and also in a clinical case series But this technique is only recommended for simple dehiscence and not a wall defect This technique is not applicable for a completely defective or missing bone wall unless a flap is raised and GBR procedure is performed Difficulty in placing the membrane as it become softened when exposed to fluid In 2020 Abd salam Elaskary introduced vestibular socket therapy VST a novel minimally invasive surgical technique that allowed placement of immediate implant in maxillary class I and class II fresh extraction sockets with or without infective signs
A 1-cm long vestibular access incision was made using a 15 blade 5-6 mm apical to the mucogingival junction of the socket exposing the alveolar bone The vestibular tissues were dissected in a coronal direction to detach the periosteum forming a sub-periosteal tunnel connecting the vestibular incision to the socket orificebone graft was then introduced through the vestibular access incision to augment the labial plate of bone and fill any jumping gap A flexible cortical membrane of 06 mm thickness was inserted and positioned 1 mm apical to the soft tissue margin and secured using two tacks apically A customized healing abutment was fabricated to cover the implant and seal the socket
This technique has many advantages firstly the nature of the vestibular extraction approach does not cause any trauma pressure or laceration to the soft tissue margin which in turn has a positive impact on enhancing the mid-facial soft tissue levels as the root was only pushed in an incisal direction through the created 6vestibular pouch thus minimizing the osteoclastic activity around the socket rim
so it overcomes the remodeling sequelae of tooth extraction and to minimize the mid facial peri-implant gingival recession
Secondly the use of a slowly resorbing flexible labial shield allowed for remodeling of the underlying labial bone plate while maintaining the socket dimensions and contours throughout the follow-up period Thirdly the membrane fixation which is known to be pivotal for the GBR stability and regenerative outcomes and finally connective tissue grafting can be done in type II sockets exhibiting a thin biotype In these cases the soft tissue graft counteracted the detrimental effect of the thin gingival phenotype on horizontal bone loss and midfacial mucosal recession
VST can manage both type I and II socket defects and could shorten the treatment time by up to two-thirds of that required for bone grafting and delayed implant placement
The incidence of tooth loss has significantly declined at the global levels However tooth loss and oral diseases are still a major public health concern worldwide
In the anterior region the common reason for tooth loss is due to traumatic injury or congenital anomaly loss of a single tooth may cause functional and esthetic deficits to the patient Tooth extraction usually accompanies alveolar ridge resorption along with loss of preexisting tissue morphology
There is a new developed a post-extraction fresh socket classification system as follows Type 1 The facial soft tissue and buccal plate of bone are at normal levels in relation to the cement enamel junction of the pre-extracted tooth and remain intact post extraction
Type 2 Facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth Type 3 The facial soft tissue and the buccal plate of the bone are both markedly reduced after tooth extraction This classification enabled ordering and classifying of post-extraction sockets
A recently published sub-classification of type 2 now allows even greater clarity to plan regeneration Type 2 A Absence of the coronal one-third of labial bone plate of the extraction socket 5mm to 6mm from the free gingival margin Type 2 B Absence of the middle to coronal two thirds of the labial bone plate of the extraction socket approximately 7mm to 9mm from the free gingival margin
Type 2 C Absence of the apical one-third of the labial bone plate of the extraction socket 10 mm or more from the free gingival margin For the management of socket defects after extraction numerous techniques have been developed to allow for optimum esthetic and functional outcomes Among those techniques are ice cream cone technique described by Deniss Tarnow and the more recently introduce vestibular socket therapy VST introduced by Abd Salam Elaskary Deniss Tarnow invented his technique ice cream cone to augment the socket with buccal dehiscence in this technique socket preservation was done using a collagen membrane shaped into an ice cream cone and placing it inside the extraction socket to cover the dehiscence site and the socket occlusally at the same time
The regeneration of the buccal plate using the ice cream cone technique was possible in the dental extraction and by the immediate implant in an infected site in a case report of a 53 years old patient and also in a clinical case series But this technique is only recommended for simple dehiscence and not a wall defect This technique is not applicable for a completely defective or missing bone wall unless a flap is raised and GBR procedure is performed Difficulty in placing the membrane as it become softened when exposed to fluid In 2020 Abd salam Elaskary introduced vestibular socket therapy VST a novel minimally invasive surgical technique that allowed placement of immediate implant in maxillary class I and class II fresh extraction sockets with or without infective signs
A 1-cm long vestibular access incision was made using a 15 blade 5-6 mm apical to the mucogingival junction of the socket exposing the alveolar bone The vestibular tissues were dissected in a coronal direction to detach the periosteum forming a sub-periosteal tunnel connecting the vestibular incision to the socket orificebone graft was then introduced through the vestibular access incision to augment the labial plate of bone and fill any jumping gap A flexible cortical membrane of 06 mm thickness was inserted and positioned 1 mm apical to the soft tissue margin and secured using two tacks apically A customized healing abutment was fabricated to cover the implant and seal the socket
This technique has many advantages firstly the nature of the vestibular extraction approach does not cause any trauma pressure or laceration to the soft tissue margin which in turn has a positive impact on enhancing the mid-facial soft tissue levels as the root was only pushed in an incisal direction through the created 6vestibular pouch thus minimizing the osteoclastic activity around the socket rim
so it overcomes the remodeling sequelae of tooth extraction and to minimize the mid facial peri-implant gingival recession
Secondly the use of a slowly resorbing flexible labial shield allowed for remodeling of the underlying labial bone plate while maintaining the socket dimensions and contours throughout the follow-up period Thirdly the membrane fixation which is known to be pivotal for the GBR stability and regenerative outcomes and finally connective tissue grafting can be done in type II sockets exhibiting a thin biotype In these cases the soft tissue graft counteracted the detrimental effect of the thin gingival phenotype on horizontal bone loss and midfacial mucosal recession
VST can manage both type I and II socket defects and could shorten the treatment time by up to two-thirds of that required for bone grafting and delayed implant placement
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