Implant Placement Using a Newly Designed Single Drill Versus Conventional Sequential Drills

Single Drill Vrs Sequential Drill Dental Implants Placement

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

Study Overview

• Status: Completed
• Conditions: Implant Complication
• Intervention / Treatment: Other: drill

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 .

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt, 71111111
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single drill; one drill to place the implants 3.25mm diameter stainless steel drill was used.	Other: drill; single 3.25 mm stainless steel drill
Active Comparator: sequential drills; For the control group, four drills (2.2mm, 2.75mm, 3.25mm and 4mm diameter),	Other: drill; single 3.25 mm stainless steel drill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mobility	the fixation of the implants checked by perio test M (-8- 0) INDICATES nonmobile	6 months
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: amr ah zahran, phd, Professor of Periodontology

Publications and helpful links

General Publications

• La Du BN. The human serum paraoxonase/arylesterase polymorphism. Am J Hum Genet. 1988 Sep;43(3):227-9. No abstract available.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2017
• Primary Completion (Actual): February 8, 2021
• Study Completion (Actual): April 20, 2021

Study Registration Dates

• First Submitted: May 1, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: implants
• Other Study ID Numbers: 17300587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: after using the single drill compared with the sequential drill all the implants checked for osseointegration , mobility and bone loss after function

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No