Implant Placement Using a Newly Designed Single Drill Versus Conventional Sequential Drills
Single Drill Vrs Sequential Drill Dental Implants Placement
1 other identifier
interventional
61
1 country
1
Brief Summary
dental implants are usually placed by sequential set of drills which could increase the time of the surgery and could raise the temperature of the osteotomy preparation so a new drill was designed to place the implants fast and easy way
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2021
CompletedFirst Submitted
Initial submission to the registry
May 1, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedMay 7, 2021
May 1, 2021
4 years
May 1, 2021
May 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
osseointegration of the dental implants
healing and union of the dental implants with the surrounding bone measured by torque wrench exceeds 30 N/CM
6 months
Secondary Outcomes (2)
mobility
6 months
bone loss
6 months , 1 ,2 and 3 years after function
Study Arms (2)
single drill
EXPERIMENTALone drill to place the implants 3.25mm diameter stainless steel drill was used.
sequential drills
ACTIVE COMPARATORFor the control group, four drills (2.2mm, 2.75mm, 3.25mm and 4mm diameter),
Interventions
Eligibility Criteria
You may qualify if:
- implant recipient sites free from any pathological conditions.
- Patients who were cooperative, motivated and hygiene conscious were selected.
- non smoker patients
You may not qualify if:
- Patients unable to undergo minor oral surgical procedures
- patients with a history of drug abuse or catabolic drugs were not included.
- Patients with a history of psychiatric disorder and those with unrealistic expectations about the aesthetic outcome of implant therapy were also excluded.
- Patients with insufficient vertical inter-arch space, on centric occlusion, to accommodate the available restorative components .
- Uncontrolled diabetic patients
- Patient who had any systemic condition that may contraindicate implant therapy (impaired wound healing - bleeding disorders
- patients who had any habits that might jeopardise the osseointegration process, such as heavy smoking and alcoholism.
- Patients with para-functional habits that produce overload on the implant, such as bruxism and clenching were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 71111111, Egypt
Related Publications (4)
La Du BN. The human serum paraoxonase/arylesterase polymorphism. Am J Hum Genet. 1988 Sep;43(3):227-9. No abstract available.
PMID: 2843045BACKGROUNDBacci C, Lucchiari N, Frigo AC, Stecco C, Zanette G, Dotto V, Sivolella S. Temperatures generated during implant site preparation with conventional drilling versus single-drill method: an ex-vivo human mandible study. Minerva Stomatol. 2019 Dec;68(6):277-284. doi: 10.23736/S0026-4970.19.04142-6.
PMID: 32052615BACKGROUNDAbboud M, Delgado-Ruiz RA, Kucine A, Rugova S, Balanta J, Calvo-Guirado JL. Multistepped Drill Design for Single-Stage Implant Site Preparation: Experimental Study in Type 2 Bone. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e472-85. doi: 10.1111/cid.12273. Epub 2014 Sep 29.
PMID: 25263993BACKGROUNDLucchiari N, Frigo AC, Stellini E, Coppe M, Berengo M, Bacci C. In Vitro Assessment with the Infrared Thermometer of Temperature Differences Generated During Implant Site Preparation: The Traditional Technique Versus the Single-Drill Technique. Clin Implant Dent Relat Res. 2016 Feb;18(1):182-91. doi: 10.1111/cid.12246. Epub 2014 Jul 17.
PMID: 25040939BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
amr ah zahran, phd
professor of periodontology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of periodontology and oral implantology - faculty of dentistry , Assiut University - Egypt
Study Record Dates
First Submitted
May 1, 2021
First Posted
May 7, 2021
Study Start
February 12, 2017
Primary Completion
February 8, 2021
Study Completion
April 20, 2021
Last Updated
May 7, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
after using the single drill compared with the sequential drill all the implants checked for osseointegration , mobility and bone loss after function