Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol

NCT03250949 | Unknown DMC

• 1 other identifier: Randomized Controlled Trial
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol

Conditions

Crestal Bone Resorption; Implant Primary Stability; Implant Osseointegration

Outcome Measures

Primary Outcomes (1)

• implant stability

  Resonance frequency analysis (RFA) OSSTELL (Osstell Resonance frequency analysis (RFA) (Osstell

  first 3 months

Secondary Outcomes (1)

• Crestal bone level

  from 3 to 6 month

Study Arms (2)

Conventional-Drilling Tight Fit (Control) group

NO INTERVENTION

osteotomy will be achieved with no. 6 round , then widened , using a drill 1 mm larger than the final drill provided by the manufacturer. the final size of the control osteotomies were same diameter of the implant.

Over-drilling Loose Fit (Test) group

EXPERIMENTAL

Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant.

Procedure: implant site over drilling protocol

Interventions

implant site over drilling protocol PROCEDURE

Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant. osteotomy site of the implant is wider by 0.2mm than the implant diameter

Also known as: NEO biotech implant system

Over-drilling Loose Fit (Test) group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who have at least one missing tooth in the upper maxillary arch.
• Patients with healthy systemic condition.(Brightman. 1994)
• Patients aged from 20 to 60 years old.
• Good oral hygiene.(Wiesner et al. 2010)
• Accepts 9 months follow-up period (cooperative patients)
• Patient provides an informed consent.

You may not qualify if:

• Patients with signs of acute infection related to the area of interest.
• Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al. 2006).
• Current and former smokers (Lambert, Morris, and Ochi 2000)
• Pregnant women

Sponsors & Collaborators

• Azhar ALI ELSAYED SELEEM: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 16, 2017
• Study Start: September 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 16, 2017

Record last verified: 2017-08