Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT07068750
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla (Randomized Controlled Clinical Trial)
Sponsor:
ALZAHRANI,MOHAMMED AHMED Y
Organization:
Study Overview
Official Title:
Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla (Randomized Controlled Clinical Trial)
Status:
COMPLETED
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 rationale for conducting this study is to compare between three implant drilling systems (conventional sequential system, single drilling system and osseodensification surgical drills) for implant site preparation in the posterior maxillay region through measuring implant stability and bone density around dental implants. Therefore, the primary objective of this study is to evaluate the primary and secondary implant stability performed by the three types through measuring implant stability quotient (ISQ), whereas the secondary objective is to assess marginal bone loss, the operation time for the osteotomy preparation, and finally bone density through measuring grey values on CBCT around implants for all drilling methods at different evaluation intervals of the study.
Detailed Description:
Primary stability is a critical factor that determines the long-term success of dental implants. It is responsible for preventing the micro- motion of the implant in the bone site, promoting natural healing and effective bone formation until adequate biological stability has been established. Primary stability of dental implants is highly dependent on implant design, surgical technique and the bone density and quality. Conventional implant shaping drills are widely used because they are easy to handle, time-efficient, and not expensive. Nevertheless, the heat that they generate might cause tissue damage, necrosis to the surrounding structures, difficulty in providing a proper three-dimensional positioning and the risk of invading and injuring important anatomical structures such as the inferior alveolar nerve and the Schneiderian membrane. Hence, several studies introduce different techniques and methods to resolve these problems. Recently, new hollow drill in a single drilling system was developed. It was hypothesized that hollow drill design with single drilling system results in decreasing the time for surgery (faster implant placement) and minimum bone removal for implant site preparation. Moreover, it was found that it reduces bone trauma, micro-fractures and allow fasters healing time. Moreover, the hollow design of the single drilling system allows harvesting of the bone core, that bone which result during the osteotomy site preparation can be used in bone grafting as autogenous bone grafting material. Osseodensification (OD) is also a new method of biomechanical bone preparation performed for dental implant placement. The procedure is characterized by low plastic deformation of bone that is created by rolling and sliding contact using a densifying bur that is fluted such that it densifies the bone with minimal heat elevation. OD, a bone nonextraction technique, was developed by Huwais 2013 and done using specially designed burs (Densah™ burs) that help densify bone as they prepare an osteotomy these burs provide advantages of both osteotomes combining the speed along with improved tactile control of the drills during osteotomy.
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?: