Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587048
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Outcome of Bone Window Approach in Endodontic Microsurgery Using Novel Piezoelectric Device
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcome of Bone Window Approach in Endodontic Microsurgery Using Novel Piezoelectric Device Versus Conventional Rotary Burs in the Treatment of Periapical Lesions - a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The Bone window technique provides excellent access to the surgical site while preserving cortical bone in cases of tooth with large periapical lesion and an intact cortical plate Traditionally rotary burs and a bone chisel were used to create a bone window Piezoelectric bone surgery on the other hand is an innovative technique that uses thin osteotomy instrument to selectively cut hard tissue while preserving soft tissues To the best of our knowledge no study comparing the results of a bone lid using a piezoelectric device and a conventional bur is currently available
Detailed Description:
Endodontic microsurgery is the treatment option frequently opted to manage endodontically failed cases with persistent apical periodontitis after nonsurgical root canal treatment 12 Contemporary surgical endodontic therapy using dental operating microscope enables a more precise technique with no or little bevel of root-end excision and retrograde canal preparation with an ultrasonic tip to a depth of 3-4 mm 3 The cumulative loss of cortical bone may further result in slowed or unsuccessful healing at the surgical site as a result of the disease process andor the removal of cortical plates during a surgical procedure 45 According to the animal histologic sections the cortical plate heals slowest with a 70 healing rate at the 6-month follow-up Von Arx et al reported that only 541 of patients demonstrated complete cortical plate healing at the end of one-year follow-up when assessed by cone-beam computed tomography CBCT 6 The degree of cortical plate loss and its limited capacity for regeneration may necessitate the use of regenerative methods involving graft materials
A novel and minimally invasive procedure called the bone window approach to the apical region aims to preserve more bony structure and the structural integrity of the healthy cortical plate The bone window also functions as autologous graft material which has been recognized as the gold standard for regeneration without the need for additional substitute materials 78 For obtaining bone window use of traditional burs in combination with chisels reciprocating or oscillating saws and lasers have been reported in literature Piezoelectric bone surgery is an innovative technology that has gained popularity in recent years It makes use of thin osteotomy instruments that enable selective hard tissue cutting while safeguarding soft tissues 9 This technique is not only clinically effective but histological and histomorphometric evidence of wound healing and bone formation in experimental animal models has shown that tissue response is better in piezo surgery than in conventional bone-cutting techniques such as diamond or carbide rotary instruments 10-12
In cases of large periapical lesions where the buccal cortical plate is intact the application of the piezoelectric device has recently been reported in case reports to create a bony window on buccal bone 13 14 In a recent randomized trial 15 piezo surgery was compared to traditional microsurgery to assess haemorrhage control and patient postoperative quality of life In a recent randomized trial 16 comparing bone lid technique over traditional technique in the surgical management of mandibular lesions the bone lid technique using a piezoelectric device was found to be safe and effective for treating lesions in the posterior mandibular region and was associated with less postoperative complications The bone lid approach has been used in the literature on oral and maxillofacial surgery for a number of procedures including root-end surgery cystic enucleation impacted tooth extraction implant explantation and access to the maxillary sinus for the removal of cysts or foreign bodies The review concluded that the included clinical studies were of low quality evidence and that randomized clinical trials were necessary to compare the effectiveness of the bone lid technique to other methods Furthermore the best cutting tool for fashioning bone lids has not yet been identified 17
The transition of endodontic diagnosis and treatment planning from two dimensions to three dimensions is facilitated by CBCT scanning which also shows the location of anatomical structures in three dimensions provides precise measurements in depth and length and enhances localization of the periapical lesion 18 19 Furthermore CBCT imaging has high sensitivity to detect the presence of a bony defect in the cortical plate and precisely measure its thickness 20 21 22
A novel and minimally invasive procedure called the bone window approach to the apical region aims to preserve more bony structure and the structural integrity of the healthy cortical plate The bone window also functions as autologous graft material which has been recognized as the gold standard for regeneration without the need for additional substitute materials 78 For obtaining bone window use of traditional burs in combination with chisels reciprocating or oscillating saws and lasers have been reported in literature Piezoelectric bone surgery is an innovative technology that has gained popularity in recent years It makes use of thin osteotomy instruments that enable selective hard tissue cutting while safeguarding soft tissues 9 This technique is not only clinically effective but histological and histomorphometric evidence of wound healing and bone formation in experimental animal models has shown that tissue response is better in piezo surgery than in conventional bone-cutting techniques such as diamond or carbide rotary instruments 10-12
In cases of large periapical lesions where the buccal cortical plate is intact the application of the piezoelectric device has recently been reported in case reports to create a bony window on buccal bone 13 14 In a recent randomized trial 15 piezo surgery was compared to traditional microsurgery to assess haemorrhage control and patient postoperative quality of life In a recent randomized trial 16 comparing bone lid technique over traditional technique in the surgical management of mandibular lesions the bone lid technique using a piezoelectric device was found to be safe and effective for treating lesions in the posterior mandibular region and was associated with less postoperative complications The bone lid approach has been used in the literature on oral and maxillofacial surgery for a number of procedures including root-end surgery cystic enucleation impacted tooth extraction implant explantation and access to the maxillary sinus for the removal of cysts or foreign bodies The review concluded that the included clinical studies were of low quality evidence and that randomized clinical trials were necessary to compare the effectiveness of the bone lid technique to other methods Furthermore the best cutting tool for fashioning bone lids has not yet been identified 17
The transition of endodontic diagnosis and treatment planning from two dimensions to three dimensions is facilitated by CBCT scanning which also shows the location of anatomical structures in three dimensions provides precise measurements in depth and length and enhances localization of the periapical lesion 18 19 Furthermore CBCT imaging has high sensitivity to detect the presence of a bony defect in the cortical plate and precisely measure its thickness 20 21 22
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