Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643676
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Targeted endodontic microsurgery represents precise and advanced approach to resolving persisting chronic periapical periodontitis after non- surgical root canal treatment This specialised procedure involves accessing the root tip of the tooth under high magnification using dental operating microscopes and employing microsurgical instruments to remove infected or inflamed tissue as well as any pathological lesions present in the periapical region Targeted Endodontic Microsurgery is useful for osteotomy and root- end resection when exacting control of depth diameter and angulation of osteotomy and root end resection is necessary Using a CBCTcone beam computed tomography designed 3D - printed surgical guideis a more accurate method for access to the apical portion of the root during surgical endodontics compared with a freehand CBCT - approximated conventional method These guided have the potential to increase accuracy and precision and to reduce intraoperative time as well as postoperative complications Additionally it provides a viable treatment option for patients who may not be candidates for traditional root canal therapy or retreatment due to anatomical complexities or previous treatment failures
Detailed Description:
Conventional Endodontic microsurgery takes use of a preoperative scan and manual drilling of the osteotomy site with arbitrary measurements followed by retropreparation and forming the apical seal One of the most critical disadvantages of conventional root-end resection include the damage to anatomically vital structures such as inferior dental nerve mental nerve adjacent root and maxillary sinus In contrast endodontic microsurgery using the guide template significantly reduces these damages Pinsky et al confirmed in their in vitro study that the greater accuracyand consistency was achieved during endodontic surgery with surgical guidance without damaging vital structures An error greater than 3 mm occurred over 22 of the time with freehand whereas none of errors occurred with surgical guidance
Consequently targeted endodontic microsurgery has garnered increasing attention as a viable alternative offering a refined and precise approach to address such challenges
Even the most skilled surgeons may find endodontic microsurgery difficult Some medical professionals steer clear using freehand FH Endodontic microsurgery in regions where there is a chance of harming important anatomical features including the maxillary sinus the mental foramen and arteries It is Perceived as complex sites include those with limited access no direct sight and areas where the apex is placed distant from the buccal cortical bone without any cortical plate fenestratio Surgeons may be able to perform precise procedures in difficult-to-reach regions with guided Endodontic Microsurgery
Guided Endodontic Microsurgery is virtually planned on 3D software on the preoperative CBCT scan and the surgeon executes the osteotomy and root-end resection RER under static or dynamic navigation
Static navigation requires a customized 3D-printed surgical guide 3D-SG to guide the drilling duringosteotomy and RER Surgical guides contain a guide template that refers to the 3D location of the virtual Endodontic Microsurgery planned in the CBCT to drill accurately Prior research has demonstrated that 3D-SG can reduce the risk of intra-operative complications whileincreasing the precision and effectiveness of EMS In comparison to free hand Endodontic Microsurgery guided Endodontic Microsurgery with 3D-Surgical Guide shortens the surgical time provides superior control over the resection level and bevel off the root and enables a tailored osteotomy size
Trephine burs have been used for the removal of failed implants and autogenous bone graft harvesting but have not previously been described in Endodontic Microsurgery
Targeted Endodontic Microsurgery produces a single-step osteotomy root-end resection and biopsy with a defined perforation site angulation depth and diameter Previous reports have used 3D Surgical Guides to locate an ideal bone perforation site but none have used trephine burs within a stent to define all parameters of osteotomy and root-end resection
Also no clinical study assessing the targeted approach of endodontic microsurgery with Oral health related quality of life has been done Some of the RCTs are conducted assessing quality of life in patients after conventional periapical surgery only two retrospective studies considering Targeted Endodontic Microsurgery have been done and a lack of RCTs comparing targeted Endodontic Microsurgery with conventionalEMS warrants further research
The aim of this study is to compare the effect of a static computer-aided surgical technique using a 3D- printed guide with a fully guided drill protocol on Oral Health Related Quality of Life against the conventional endodontic microsurgery in mandibular molars
Consequently targeted endodontic microsurgery has garnered increasing attention as a viable alternative offering a refined and precise approach to address such challenges
Even the most skilled surgeons may find endodontic microsurgery difficult Some medical professionals steer clear using freehand FH Endodontic microsurgery in regions where there is a chance of harming important anatomical features including the maxillary sinus the mental foramen and arteries It is Perceived as complex sites include those with limited access no direct sight and areas where the apex is placed distant from the buccal cortical bone without any cortical plate fenestratio Surgeons may be able to perform precise procedures in difficult-to-reach regions with guided Endodontic Microsurgery
Guided Endodontic Microsurgery is virtually planned on 3D software on the preoperative CBCT scan and the surgeon executes the osteotomy and root-end resection RER under static or dynamic navigation
Static navigation requires a customized 3D-printed surgical guide 3D-SG to guide the drilling duringosteotomy and RER Surgical guides contain a guide template that refers to the 3D location of the virtual Endodontic Microsurgery planned in the CBCT to drill accurately Prior research has demonstrated that 3D-SG can reduce the risk of intra-operative complications whileincreasing the precision and effectiveness of EMS In comparison to free hand Endodontic Microsurgery guided Endodontic Microsurgery with 3D-Surgical Guide shortens the surgical time provides superior control over the resection level and bevel off the root and enables a tailored osteotomy size
Trephine burs have been used for the removal of failed implants and autogenous bone graft harvesting but have not previously been described in Endodontic Microsurgery
Targeted Endodontic Microsurgery produces a single-step osteotomy root-end resection and biopsy with a defined perforation site angulation depth and diameter Previous reports have used 3D Surgical Guides to locate an ideal bone perforation site but none have used trephine burs within a stent to define all parameters of osteotomy and root-end resection
Also no clinical study assessing the targeted approach of endodontic microsurgery with Oral health related quality of life has been done Some of the RCTs are conducted assessing quality of life in patients after conventional periapical surgery only two retrospective studies considering Targeted Endodontic Microsurgery have been done and a lack of RCTs comparing targeted Endodontic Microsurgery with conventionalEMS warrants further research
The aim of this study is to compare the effect of a static computer-aided surgical technique using a 3D- printed guide with a fully guided drill protocol on Oral Health Related Quality of Life against the conventional endodontic microsurgery in mandibular molars
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