Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
Study NCT ID:
NCT06891261
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-02-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
One Stage Ridge Splitting Using 2 Different Techniques in Maxilla
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Evaluation of Endosseous Implants in One Stage Ridge Splitting Using the Conventional Technique Versus the Use of Piezo Surgery in the Maxilla
Status:
RECRUITING
Status Verified Date:
2025-07
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 selected patients will be informed of the nature of the research work and informed consent will be obtained.
* Patients of both groups will be subjected to CBCT.
* Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
* Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)
Both the study and control group will receive:
* In Recipient site, full thickness mucoperiosteal flap pyramidal flap, reflection using mucoperiosteal elevator.
* The defective site is reevaluated.
* Flap advancement inorder to allow tension free flap closure.
* In the Study group: Piezo surgery bone inserts is used to cut crestal osteotomies.
* In the Control group: Bone discs diameter is used.
* Followed by, the use of bone chisels.
* The point and pilot implant drills are used followed by bone expanders. Based on the preexisting bone, the defect morphology and bone quality. The implant is submerged below the alveolar crest to compensate for crestal bone resorption.
* Following partial immobilization of the buccal bone segment either book or island pattern. The fixture is inserted submerged below the alveolar bone crest.
Followed by bone smoothening and roundation under external saline irrigation at recommended speed of 38000rpm and gear ratio 1:1 calibrated on fesiodespenser.
* Xenogenic bone particle size of 0.5 mm to 1mm is going to be condensed into the dead space.
* Recheck adequate flap advancement to allow tension free closure.
* Double line closure using horizontal mattress followed by interrupted sutures to allow contact area and wound edge eversion.
* Patients of both groups will be subjected to CBCT.
* Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
* Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)
Both the study and control group will receive:
* In Recipient site, full thickness mucoperiosteal flap pyramidal flap, reflection using mucoperiosteal elevator.
* The defective site is reevaluated.
* Flap advancement inorder to allow tension free flap closure.
* In the Study group: Piezo surgery bone inserts is used to cut crestal osteotomies.
* In the Control group: Bone discs diameter is used.
* Followed by, the use of bone chisels.
* The point and pilot implant drills are used followed by bone expanders. Based on the preexisting bone, the defect morphology and bone quality. The implant is submerged below the alveolar crest to compensate for crestal bone resorption.
* Following partial immobilization of the buccal bone segment either book or island pattern. The fixture is inserted submerged below the alveolar bone crest.
Followed by bone smoothening and roundation under external saline irrigation at recommended speed of 38000rpm and gear ratio 1:1 calibrated on fesiodespenser.
* Xenogenic bone particle size of 0.5 mm to 1mm is going to be condensed into the dead space.
* Recheck adequate flap advancement to allow tension free closure.
* Double line closure using horizontal mattress followed by interrupted sutures to allow contact area and wound edge eversion.
Detailed Description:
* The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group conventional ridge splitting and study ridge splitting using piezo surgery.
* Patients of both groups will be subjected to CBCT (diagnostic for upper arch), diagnostic wax-up and stent fabrication.
* Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
* Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
* Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)
Both the study and control group will receive:
* In Recipient site, using 15C blade on Bard Parker handle incision of full thickness mucoperiosteal flap inorder to obtain, three-line pyramidal flap, reflection using mucoperiosteal elevator molt 9.
* The defective site is reevaluated after its primary evaluation on CBCT using UNC periodontal probe.
* Flap advancement using periosteal releasing incision inorder to allow later tension free flap closure.
* In the Study group: Piezo surgery bone inserts is used to cut crestal osteotomy in the center of the alveolar bone ridge bucco-lingual traversing the compact bone into the spongiosa Followed by two semi vertical osteotomies at least 1.5mm away from the adjacent teeth.
* In the Control group: Bone discs diameter 7mm mounted on contra angled 1:1 is used to cut crestal osteotomy in the center of the alveolar bone ridge bucco-lingual traversing the compact bone into the spongiosa Followed by two semi vertical osteotomies at least 1.5mm away from the adjacent teeth using bone discs diameter 6.5mm mounted on external irrigation straight hand piece.
* First, the spatula bone chisels are used to make sure of extension of osteotomies into the spongy bone in addition to, adequate free of the cut corners, followed by sequential use of tapered bi-angled bone chisels and hammering with bone mallet 3mm shorter than the length of the proposed implant to gain adequate 1ry stability with concurrent support of the buccal plate of bone.
* The point and pilot implant drills are used followed by the sequential use of bone expanders diameters 2.6, 3, 3.4, 3.8 to place an implant of diameter 3.7 or 4.1mm. Based on the preexisting bone, the defect morphology and bone quality. The implant is submerged about 2mm to 3mm below the alveolar crest to compensate for crestal bone resorption.
* Following partial immobilization of the buccal bone segment either book or island pattern. The fixture is inserted submerged below the alveolar bone crest by 2mm to 3mm. Followed by bone smoothening and roundation using large round diamond stone mounted on straight hand piece with external saline irrigation at recommended speed of 38000rpm and gear ratio 1:1 calibrated on fesiodespenser. To avoid soft tissue irritation.
* Xenogenic bone particle size of 0.5 mm to 1mm is going to be condensed into the dead space. To act as a scaffold for the formation of autogenous bone.
* Recheck adequate flap advancement by visualizing passive flap approximation, to allow tension free closure.
* Double line closure using horizontal mattress placed 5mm away from flap margins followed by interrupted sutures on top to allow contact area which is preferred to point contact and wound edge eversion.
* Patients of both groups will be subjected to CBCT (diagnostic for upper arch), diagnostic wax-up and stent fabrication.
* Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
* Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
* Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)
Both the study and control group will receive:
* In Recipient site, using 15C blade on Bard Parker handle incision of full thickness mucoperiosteal flap inorder to obtain, three-line pyramidal flap, reflection using mucoperiosteal elevator molt 9.
* The defective site is reevaluated after its primary evaluation on CBCT using UNC periodontal probe.
* Flap advancement using periosteal releasing incision inorder to allow later tension free flap closure.
* In the Study group: Piezo surgery bone inserts is used to cut crestal osteotomy in the center of the alveolar bone ridge bucco-lingual traversing the compact bone into the spongiosa Followed by two semi vertical osteotomies at least 1.5mm away from the adjacent teeth.
* In the Control group: Bone discs diameter 7mm mounted on contra angled 1:1 is used to cut crestal osteotomy in the center of the alveolar bone ridge bucco-lingual traversing the compact bone into the spongiosa Followed by two semi vertical osteotomies at least 1.5mm away from the adjacent teeth using bone discs diameter 6.5mm mounted on external irrigation straight hand piece.
* First, the spatula bone chisels are used to make sure of extension of osteotomies into the spongy bone in addition to, adequate free of the cut corners, followed by sequential use of tapered bi-angled bone chisels and hammering with bone mallet 3mm shorter than the length of the proposed implant to gain adequate 1ry stability with concurrent support of the buccal plate of bone.
* The point and pilot implant drills are used followed by the sequential use of bone expanders diameters 2.6, 3, 3.4, 3.8 to place an implant of diameter 3.7 or 4.1mm. Based on the preexisting bone, the defect morphology and bone quality. The implant is submerged about 2mm to 3mm below the alveolar crest to compensate for crestal bone resorption.
* Following partial immobilization of the buccal bone segment either book or island pattern. The fixture is inserted submerged below the alveolar bone crest by 2mm to 3mm. Followed by bone smoothening and roundation using large round diamond stone mounted on straight hand piece with external saline irrigation at recommended speed of 38000rpm and gear ratio 1:1 calibrated on fesiodespenser. To avoid soft tissue irritation.
* Xenogenic bone particle size of 0.5 mm to 1mm is going to be condensed into the dead space. To act as a scaffold for the formation of autogenous bone.
* Recheck adequate flap advancement by visualizing passive flap approximation, to allow tension free closure.
* Double line closure using horizontal mattress placed 5mm away from flap margins followed by interrupted sutures on top to allow contact area which is preferred to point contact and wound edge eversion.
Study Oversight
Has Oversight DMC:
False
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?: