Ignite Creation Date:
2024-07-17 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478511
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-06-24
Brief Title:
Subepithelial Connective Tissue Graft Versus Socket Shield Technique In Immediately Placed Implants
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Subepithelial Connective Tissue Graft Versus Socket Shield Technique In Immediately Placed Implants In Maxillary Esthetic Region A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-06
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 purposes of study are
1 To assess the efficacy of immediate implant placement in preserving hard and soft tissue around implants clinically and radiographically
2 To assess the efficacy of immediate implant placement combined with subepithelial connective tissue graft in preserving hard and soft tissue around implants clinically and radiographically
3 To assess the efficacy of implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically
4 To compare immediate implant placement versus implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically
1 To assess the efficacy of immediate implant placement in preserving hard and soft tissue around implants clinically and radiographically
2 To assess the efficacy of immediate implant placement combined with subepithelial connective tissue graft in preserving hard and soft tissue around implants clinically and radiographically
3 To assess the efficacy of implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically
4 To compare immediate implant placement versus implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically
Detailed Description:
Patients selection
Patients in this study will be selected from the outpatient clinic of Oral Medicine and Periodontology department Faculty of Dentistry Mansoura University
Patients participating in this study will sign an informed consent demonstrating the purpose of this study treatment procedure probable risks and benefits from this treatment procedure The study proposal will be reviewed by the facultys Research Ethics Committee
All the selected patients will receive full mouth scaling preoperative periapical x-ray and cone beam computed
Surgical procedures
Before surgery Preoperative antibiotics will be given orally one hour prior to surgery amoxicillin 2g or clindamycin 600 mg for patients allergic to penicillin the patients will be advised to rinse for one minute with chlorhexidiene mouthwash After local anesthesia administration In group 1 the teeth will be extracted gently using periotomes in an attempt to preserve facial and lingual bone plates The sockets will be debrided of soft tissue and irrigated Then all walls of the socket will be inspected and checked for the presence of fenestration or dehiscence defects in bone The length and width of extracted roots will be measured to determine the length and diameter of implants placed The osteotomy sites will be prepared and the drills will be used in proper sequence according to manufacturers instructions with maximum use of bone apical to the extraction sockets The drills will extend 3 to 5 mm beyond the apex of the socket to ensure primary stability after placement taking care of the anatomical boundaries After the osteotomy sites had been prepared the implants will be placed
In group 2 concerning the donor site of the connective tissue connective tissue graft was harvested from palate using trap door technique 27 utilizing a horizontal incision 3-4 mm away from the gingival margin with two vertical incisions on the either end of the first incision creating a door the door is then undermined and opened using a sharp dissection the underlying connective tissue is then harvested using a periosteal elevator and the door was then sutured using 4 0 silk sutures Finally the connective tissue graft was immediately placed into the recipient site after a tunneling procedure and sutured with 6-0 nonresorbable monofilament sutures
In group 3 the crown of the involved tooth will be removed and the root will be then sectioned in a mesiodistal direction along its long axis as far apical as was possible using a long shank fissure bur coupled to a hydrated high-speed handpiece Sectioning will divide the tooth root into facial and palatal halves with the intention of preserving the facial root section unmanipulated and attached to the tooth socket Periotomes will be then inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root will be then carefully delivered with so as not to disturb the facial root section
The remaining root section will be then reduced coronally to 1 mm above the alveolar crest and will be thinned slightly to a concave contour by careful application in an apico-coronal and mesiodistal direction with a long shanked round diamond The tooth sockets palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section will be checked for immobility with a sharp probe With the preparation steps complete the tooth root hereafter will be known as the socket-shield An osteotomy will be then sequentially prepared and internal conical connection implant was inserted palatal to the socket shield with the implant 2 mm below the facial crest
Immediate temporary dentures were fabricated using plastic and inserted on the day of implantation Patients were instructed to consume soft food for eight weeks Following a healing period of 6 months the final restorations will be delivered
Patients in this study will be selected from the outpatient clinic of Oral Medicine and Periodontology department Faculty of Dentistry Mansoura University
Patients participating in this study will sign an informed consent demonstrating the purpose of this study treatment procedure probable risks and benefits from this treatment procedure The study proposal will be reviewed by the facultys Research Ethics Committee
All the selected patients will receive full mouth scaling preoperative periapical x-ray and cone beam computed
Surgical procedures
Before surgery Preoperative antibiotics will be given orally one hour prior to surgery amoxicillin 2g or clindamycin 600 mg for patients allergic to penicillin the patients will be advised to rinse for one minute with chlorhexidiene mouthwash After local anesthesia administration In group 1 the teeth will be extracted gently using periotomes in an attempt to preserve facial and lingual bone plates The sockets will be debrided of soft tissue and irrigated Then all walls of the socket will be inspected and checked for the presence of fenestration or dehiscence defects in bone The length and width of extracted roots will be measured to determine the length and diameter of implants placed The osteotomy sites will be prepared and the drills will be used in proper sequence according to manufacturers instructions with maximum use of bone apical to the extraction sockets The drills will extend 3 to 5 mm beyond the apex of the socket to ensure primary stability after placement taking care of the anatomical boundaries After the osteotomy sites had been prepared the implants will be placed
In group 2 concerning the donor site of the connective tissue connective tissue graft was harvested from palate using trap door technique 27 utilizing a horizontal incision 3-4 mm away from the gingival margin with two vertical incisions on the either end of the first incision creating a door the door is then undermined and opened using a sharp dissection the underlying connective tissue is then harvested using a periosteal elevator and the door was then sutured using 4 0 silk sutures Finally the connective tissue graft was immediately placed into the recipient site after a tunneling procedure and sutured with 6-0 nonresorbable monofilament sutures
In group 3 the crown of the involved tooth will be removed and the root will be then sectioned in a mesiodistal direction along its long axis as far apical as was possible using a long shank fissure bur coupled to a hydrated high-speed handpiece Sectioning will divide the tooth root into facial and palatal halves with the intention of preserving the facial root section unmanipulated and attached to the tooth socket Periotomes will be then inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root will be then carefully delivered with so as not to disturb the facial root section
The remaining root section will be then reduced coronally to 1 mm above the alveolar crest and will be thinned slightly to a concave contour by careful application in an apico-coronal and mesiodistal direction with a long shanked round diamond The tooth sockets palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section will be checked for immobility with a sharp probe With the preparation steps complete the tooth root hereafter will be known as the socket-shield An osteotomy will be then sequentially prepared and internal conical connection implant was inserted palatal to the socket shield with the implant 2 mm below the facial crest
Immediate temporary dentures were fabricated using plastic and inserted on the day of implantation Patients were instructed to consume soft food for eight weeks Following a healing period of 6 months the final restorations will be delivered
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