Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-31 @ 6:06 AM
Study NCT ID:
NCT05559632
Status:
UNKNOWN
Last Update Posted:
2022-09-29
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
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:
Is to compare between the conventional drills versus osseodensification drills for implant stability and peri-implant marginal bone loss in maxillary implant overdenture.
Detailed Description:
Comprehensive clinical examination and understanding of patient's chief complaints and their expectations from the prosthesis.
* medical and dental history
* A complete denture will be constructed for each patient to aid in the scan technique, if the patient has an denture, it will be evaluated to be used.
* The complete denture will be constructed following conventional denture fabrication procedures.
* CBCT radiograph will be taken for bone height and width, and identify the vital structures before implant placement.
* A surgical guide will be used to aid in the implant placement, each patient will be scheduled for surgery to insert four root form implants. Each patient will receive four implants at canine and premolar regions from the same implant manufacturer.
Study group: The osseodensification drilling group (G1), bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion.
Control group: In the conventional drilling group (G2), drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction.
* All patients received 2gm/day amoxicillin, clavulanate and 50 mg/8 hours non-steroidal anti-inflammatory analgesics for 5 days postoperatively. Postoperative instructions included a soft diet and appropriate oral hygiene measures with 0.2% chlorhexidine mouth rinse.
* After four months, the implants will be exposed and attachment (stud attachment) will be screwed to the implants. Then, overdenture pick-up is done. \* Number of visits \& follow up period
* 5 visits for construction of denture
* 1 visit for CBCT
* 1 visit for implant insertion
* 1 visit for attachment placement and pick-up of overdenture
* Patients will be recalled at base line,4 and 7 weeks 4 and 12 months following implant insertion for outcomes assessment
* medical and dental history
* A complete denture will be constructed for each patient to aid in the scan technique, if the patient has an denture, it will be evaluated to be used.
* The complete denture will be constructed following conventional denture fabrication procedures.
* CBCT radiograph will be taken for bone height and width, and identify the vital structures before implant placement.
* A surgical guide will be used to aid in the implant placement, each patient will be scheduled for surgery to insert four root form implants. Each patient will receive four implants at canine and premolar regions from the same implant manufacturer.
Study group: The osseodensification drilling group (G1), bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion.
Control group: In the conventional drilling group (G2), drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction.
* All patients received 2gm/day amoxicillin, clavulanate and 50 mg/8 hours non-steroidal anti-inflammatory analgesics for 5 days postoperatively. Postoperative instructions included a soft diet and appropriate oral hygiene measures with 0.2% chlorhexidine mouth rinse.
* After four months, the implants will be exposed and attachment (stud attachment) will be screwed to the implants. Then, overdenture pick-up is done. \* Number of visits \& follow up period
* 5 visits for construction of denture
* 1 visit for CBCT
* 1 visit for implant insertion
* 1 visit for attachment placement and pick-up of overdenture
* Patients will be recalled at base line,4 and 7 weeks 4 and 12 months following implant insertion for outcomes assessment
Study Oversight
Has Oversight DMC:
True
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?: