Clinical trial NCT04877145: Implant Placement Using a Newly Designed Single Drill Versus Conventional Sequential Drills
Official title: Single Drill Vrs Sequential Drill Dental Implants Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Complication
Keywords: implants
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: osseointegration of the dental implants
timeFrame: 6 months
Secondary outcomes:
measure: mobility
timeFrame: 6 months
measure: bone loss
timeFrame: 6 months , 1 ,2 and 3 years after function
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assiut University
Study officials:
affiliation: professor of periodontology
name: amr ah zahran, phd
role: STUDY_DIRECTOR
References:
citation: La Du BN. The human serum paraoxonase/arylesterase polymorphism. Am J Hum Genet. 1988 Sep;43(3):227-9. No abstract available.
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.
citation: 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.
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.