Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol (RCT)
Primary Purpose
Crestal Bone Resorption, Implant Primary Stability, Implant Osseointegration
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
implant site over drilling protocol
Sponsored by
About this trial
This is an interventional prevention trial for Crestal Bone Resorption
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional-Drilling Tight Fit (Control) group
Over-drilling Loose Fit (Test) group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
implant stability
Resonance frequency analysis (RFA) OSSTELL (Osstell Resonance frequency analysis (RFA) (Osstell
Secondary Outcome Measures
Crestal bone level
by Digital radiography
Full Information
NCT ID
NCT03250949
First Posted
August 10, 2017
Last Updated
August 14, 2017
Sponsor
Azhar ALI ELSAYED SELEEM
1. Study Identification
Unique Protocol Identification Number
NCT03250949
Brief Title
Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol
Acronym
RCT
Official Title
Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Azhar ALI ELSAYED SELEEM
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol
Detailed Description
- Statement of the problem:
peri-implant bone is affected by excessive mechanical stress, the mechanism of bone formation is reduced and the bone resorption is increased, leading to MBL. Isidor F. 2006, Warreth A, 009 A drilling sequence using a drill that is smaller than the implant diameter has been applied as a way to obtain enough initial stability.Bilhan H,2010 However, the implant can be extremely compressed or exceed the torque, which can be higher than the elastic limit of bone when a drill that is smaller than the implant diameter is used. This may affect the bone surrounding the implant and may also lead to a micro fracture.
Frost mentioned that alveolar bone density is changed by micro deformation due to modification of the physical condition. Bone resorption and fibrous tissue production progress if the micro deformation rate is higher than 3,000 micro strain (με). Also, continuous bone replacement occurs while woven bone appears. Wolff J.1986 Bone tissue adapts to the change of stress while minimizing its weight and transforming its structure. Frost HM,1989 The bone formation mechanism is inhibited and the bone resorption mechanism is enhanced if excessive mechanical stress is applied to alveolar bone during implantation, resulting in the progression of marginal bone loss (MBL). Isidor F.2006 , Warreth A,2009-
Rationale for carrying out the trial:
Success and survival rate of an implant are directly associated with primary stability. Friberg B,et al 1991 Primary stability is achieved with initial rigid fixation of implants during the surgery and considered necessary for a successful osseointegration. Sennerby L,et al 1992, Rodrigo D,et al 2010 There are two different processes of bone formation at implant sites; contact and distance osteogenesis. Contact osteogenesis infers new bone formation in direct contact with the implant surface. Distance osteogenesis is the new bone formation on the surfaces of the parent bone and occurs when primary stability is absent at implant site. Davies JE.et al 2003, Sivolella S,et al2012
When there is a gap between the implant surface and bone, a clot will fill the space and will be replaced by a provisional connective matrix that will act as scaffold for formation of woven bone. Berglundh T,et al,2003 , Rossi F,2012 Our study will evaluate the effect of oversized drilling on implant success and secondary stability
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crestal Bone Resorption, Implant Primary Stability, Implant Osseointegration
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional-Drilling Tight Fit (Control) group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Over-drilling Loose Fit (Test) group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
implant site over drilling protocol
Other Intervention Name(s)
NEO biotech implant system
Intervention Description
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
Primary Outcome Measure Information:
Title
implant stability
Description
Resonance frequency analysis (RFA) OSSTELL (Osstell Resonance frequency analysis (RFA) (Osstell
Time Frame
first 3 months
Secondary Outcome Measure Information:
Title
Crestal bone level
Description
by Digital radiography
Time Frame
from 3 to 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol
We'll reach out to this number within 24 hrs