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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04877145
Other study ID # 17300587
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2017
Est. completion date April 20, 2021

Study information

Verified date May 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Dental implant success is evident nowadays with the predictable functional and aesthetic results obtained . Simplified techniques and approaches are preferred for the convenience of both the patients and operators . Current research is focusing on decreasing the number of instruments used, shortening of the operation time and performing flapless approaches for implant placement whenever possible. This is done to reduce the postoperative complaints, such as pain, swelling and bleeding; thus decreasing the need for analgesics and minimising the occurrence of morbidity .


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date April 20, 2021
Est. primary completion date February 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - The inclusion criteria : - implant recipient sites free from any pathological conditions. - Patients who were cooperative, motivated and hygiene conscious were selected. - non smoker patients - exclusion criteria : - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
drill
single 3.25 mm stainless steel drill

Locations

Country Name City State
Egypt Assiut University Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Abboud 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. — View Citation

Bacci 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. — View Citation

La Du BN. The human serum paraoxonase/arylesterase polymorphism. Am J Hum Genet. 1988 Sep;43(3):227-9. Review. — View Citation

Lucchiari 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 mobility the fixation of the implants checked by perio test M (-8- 0) INDICATES nonmobile 6 months
Secondary bone loss by periapical xray the bone loss measured from the platform of the implant if present unit of measurement : mm 6 months , 1 ,2 and 3 years after function
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