Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519773
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Modified Periosteal Inhibition With Simultaneous Implant Placement in Aesthetic Zone
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Modified Periosteal Inhibition Utilizing Bone Graft Versus Collagen Sponge With Simultaneous Implant Placement in Aesthetic Zone
Status:
RECRUITING
Status Verified Date:
2024-07
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:
A randomized controlled clinical and radiographic trial Twenty sites with remaining roots or non-restorable teeth in the maxillary anterior region that fulfill the inclusion criteria will be selected from the Periodontology Clinic Faculty of Dentistry Tanta University These sites will be divided into two groups each of which has ten surgical sites After phase I therapy a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue
Once the tooth is extracted the socket is gently debrided and irrigated using sterile saline solution Then the dental implant is placed in the best prosthetic driven position following the guidelines for immediate implants using prefabricated computer guided surgical template
After accurate implant placement a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope A bone lamina 1 mm thickness will be trimmed and hydrated in sterile saline solution for 30 s to soften it it should be 1-2 mm larger and deeper than the vestibular bone
Once the tooth is extracted the socket is gently debrided and irrigated using sterile saline solution Then the dental implant is placed in the best prosthetic driven position following the guidelines for immediate implants using prefabricated computer guided surgical template
After accurate implant placement a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope A bone lamina 1 mm thickness will be trimmed and hydrated in sterile saline solution for 30 s to soften it it should be 1-2 mm larger and deeper than the vestibular bone
Detailed Description:
A randomized controlled clinical and radiographic trial The purpose of the present study will be explained to the patients and informed consents will be obtained according to guidelines adopted by the Research Ethics Committee Faculty of Dentistry Tanta University Twenty sites with remaining roots or non-restorable teeth in the maxillary anterior region that fulfill the inclusion criteria will be selected from the Periodontology Clinic Faculty of Dentistry Tanta University Twenty surgical sites will be divided into two groups each of which has ten surgical sites Grouping will be done randomly sequentially numbered opaque sealed envelopes SNOSE
1 Phase I therapy
Full mouth supra and subgingival scaling and root planing will be performed to all enrolled patients Patients will be instructed to rinse twice daily with 012 chlorohexidine mouth wash for 2 weeks
Before tooth extraction initial radiographic records by cone beam computed tomography CBCT scans of the maxillary arch will be made The pre-extraction measurements will be taken from CBCT scans to evaluate the presence of a fully intact labial plate of bone 1 mm The labial plate thickness of the tooth to be extracted will be measured on cross sectional cuts at three levels below the labial bone crest 0 2 and 5 mm
2 Surgical technique
After local anathesia a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue
Once the tooth is extracted the socket is gently debrided and irrigated using sterile saline solution Then the dental implant provided by Auto Fit Dental Implant is placed in the best prosthetic driven position following the guidelines for immediate implants using prefabricated computer guided surgical template
After accurate implant placement a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope A bone lamina provided by GRANNTIE 1 mm thickness will be trimmed and hydrated in sterile saline solution for 30 s to soften it it should be 1-2 mm larger and deeper than the vestibular bone
The labial gap will be filled either with bone graft Regeinoss cortico cancelleous granules with collagen- xenograft GRANNTIE or collagen sponge
The socket orifice will be sealed using a customized healing abutment screwed to the implant adequately finished and polished to ensure a proper soft tissue emergence profile The papilla will be sutured back using 50 polypropylene sling suture For all cases the sutures will be removed after 2 weeks
3 Postoperative Phase -All subjects will receive postoperative instructions including
Rinsing with 01 Chlorhexidine mouth rinse twice daily for two weeks
Antibiotics combination of 500 mg Metronidazole along with Amoxicillin Clavulanate Augmentin 1g every 12 hours one day preoperatively and continuing for 5 days after extraction
Non-steroidal anti-inflammatory NSAID medication of Ibuprofen 400 mg twice daily for one week
1 Phase I therapy
Full mouth supra and subgingival scaling and root planing will be performed to all enrolled patients Patients will be instructed to rinse twice daily with 012 chlorohexidine mouth wash for 2 weeks
Before tooth extraction initial radiographic records by cone beam computed tomography CBCT scans of the maxillary arch will be made The pre-extraction measurements will be taken from CBCT scans to evaluate the presence of a fully intact labial plate of bone 1 mm The labial plate thickness of the tooth to be extracted will be measured on cross sectional cuts at three levels below the labial bone crest 0 2 and 5 mm
2 Surgical technique
After local anathesia a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue
Once the tooth is extracted the socket is gently debrided and irrigated using sterile saline solution Then the dental implant provided by Auto Fit Dental Implant is placed in the best prosthetic driven position following the guidelines for immediate implants using prefabricated computer guided surgical template
After accurate implant placement a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope A bone lamina provided by GRANNTIE 1 mm thickness will be trimmed and hydrated in sterile saline solution for 30 s to soften it it should be 1-2 mm larger and deeper than the vestibular bone
The labial gap will be filled either with bone graft Regeinoss cortico cancelleous granules with collagen- xenograft GRANNTIE or collagen sponge
The socket orifice will be sealed using a customized healing abutment screwed to the implant adequately finished and polished to ensure a proper soft tissue emergence profile The papilla will be sutured back using 50 polypropylene sling suture For all cases the sutures will be removed after 2 weeks
3 Postoperative Phase -All subjects will receive postoperative instructions including
Rinsing with 01 Chlorhexidine mouth rinse twice daily for two weeks
Antibiotics combination of 500 mg Metronidazole along with Amoxicillin Clavulanate Augmentin 1g every 12 hours one day preoperatively and continuing for 5 days after extraction
Non-steroidal anti-inflammatory NSAID medication of Ibuprofen 400 mg twice daily for one week
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