Back to resultsClinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique.
Primary Purpose
Dental Implant
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
New Reverse Drilling technique
osteotome technique
Sponsored by
About this trial
This is an interventional treatment trial for Dental Implant
Eligibility Criteria
Inclusion criteria:
- Partially edentulous patients in the maxillary posterior region.
- Systemically healthy patient.
- Presence of proper inter-arch space for placement of the implant prosthetic part.
- Sufficient bone height and width for implant placement (bone height ≥10mm and bone width ≥6mm).
- Non-smoker.
- Patients who are ≥ 20 years old.
- Good oral hygiene.
- Acceptance of a one year follow-up period.
- Informed consent is provided by the patient.
Exclusion criteria:
- Patients with systemic conditions that may interfere with implant stability,
- Patients with local pathological defects related to the area of interest.
- Unmotivated, uncooperative patients with poor oral hygiene.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
- Inadequate inter-arch space for implant prosthetic part
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
osteotome group
New Reverse Drilling technique
Arm Description
Outcomes
Primary Outcome Measures
implant stability
the stability of the dental implant when placed in the maxilla of the patient and it will be measured by periotest
Secondary Outcome Measures
crestal bone loss
amount of bone loss around the implant . measured in MM with CBVT radiograph
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04541641
Brief Title
Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique.
Official Title
Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study will compare between osteotome technique and New Reverse Drilling Technique in the placement of dental implant in posterior maxilla , primary outcome will be Implant stability that will be measured by Periotest device . follow up for 6 month.
secondary outcomes will be crestal bone loss , pain and swelling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
osteotome group
Arm Type
Experimental
Arm Title
New Reverse Drilling technique
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
New Reverse Drilling technique
Intervention Description
a new technique of dental implant drilling that promote osseodensification by rotating the drills anti-clockwise rather than clockwise to promote bone condensation rather than bone cutting
Intervention Type
Procedure
Intervention Name(s)
osteotome technique
Intervention Description
a technique for dental implant placement by using the osteotome to condense the bone and create an osteotome rather than cutting the bone
Primary Outcome Measure Information:
Title
implant stability
Description
the stability of the dental implant when placed in the maxilla of the patient and it will be measured by periotest
Time Frame
6 months
Secondary Outcome Measure Information:
Title
crestal bone loss
Description
amount of bone loss around the implant . measured in MM with CBVT radiograph
Time Frame
6 monthz
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Partially edentulous patients in the maxillary posterior region.
Systemically healthy patient.
Presence of proper inter-arch space for placement of the implant prosthetic part.
Sufficient bone height and width for implant placement (bone height ≥10mm and bone width ≥6mm).
Non-smoker.
Patients who are ≥ 20 years old.
Good oral hygiene.
Acceptance of a one year follow-up period.
Informed consent is provided by the patient.
Exclusion criteria:
Patients with systemic conditions that may interfere with implant stability,
Patients with local pathological defects related to the area of interest.
Unmotivated, uncooperative patients with poor oral hygiene.
Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
Inadequate inter-arch space for implant prosthetic part
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique.
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