Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique.
1 other identifier
interventional
28
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedSeptember 9, 2020
September 1, 2020
1.8 years
July 27, 2020
September 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
implant stability
the stability of the dental implant when placed in the maxilla of the patient and it will be measured by periotest
6 months
Secondary Outcomes (1)
crestal bone loss
6 monthz
Study Arms (2)
osteotome group
EXPERIMENTALNew Reverse Drilling technique
EXPERIMENTALInterventions
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
a technique for dental implant placement by using the osteotome to condense the bone and create an osteotome rather than cutting the bone
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctorate candidate
Study Record Dates
First Submitted
July 27, 2020
First Posted
September 9, 2020
Study Start
October 1, 2020
Primary Completion
August 1, 2022
Study Completion
August 1, 2023
Last Updated
September 9, 2020
Record last verified: 2020-09