Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group C ) A Randomized Controlled Clinical Trial
Primary Purpose
Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drilling at low speed
Drilling at conventional or high speed
Sponsored by
About this trial
This is an interventional treatment trial for Bone Resorption
Eligibility Criteria
Inclusion Criteria:
- Patients restoring missing maxillary teeth with implant placement.
- Both sexes.
- Age: 25-45
- Mesio-distal dimensions: Not less than 6 mm
- Bone Height: Not less than 12 mm
- Bucco-lingual dimensions: Not less than 8mm
- All measures will be assessed using CBCT.
Exclusion Criteria:
- Sites needing bone grafting or augmentation.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biologic drilling drilling at low speed
conventional drilling drilling at convention
Arm Description
Procedure/Surgery: Drilling at low speed
Procedure/Surgery: Drilling at conventional or high speed
Outcomes
Primary Outcome Measures
crestal bone loss
measurement from radiographic analysis using digital periapical x-ray
Secondary Outcome Measures
patient morbidity after procedure
pain value on pain scale
Implant stability value
resonance frequency analysis using osstell
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03220789
Brief Title
Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group C ) A Randomized Controlled Clinical Trial
Official Title
Clinical Evaluation of the Effect of Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla. A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
September 2017 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)
for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .
In the study group: implant will be inserted in the low speed osteotomy site.
In the control group: implants will be inserted in the conventional prepared osteotomy site.
For both groups there is no surgical guide used.
The flap will then be copiously irrigated with saline in preparation for closure.
The flap will then be closed using interrupted 4/0 resorbable sutures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biologic drilling drilling at low speed
Arm Type
Experimental
Arm Description
Procedure/Surgery: Drilling at low speed
Arm Title
conventional drilling drilling at convention
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Drilling at conventional or high speed
Intervention Type
Procedure
Intervention Name(s)
Drilling at low speed
Intervention Type
Procedure
Intervention Name(s)
Drilling at conventional or high speed
Primary Outcome Measure Information:
Title
crestal bone loss
Description
measurement from radiographic analysis using digital periapical x-ray
Time Frame
6 months
Secondary Outcome Measure Information:
Title
patient morbidity after procedure
Description
pain value on pain scale
Time Frame
1 day
Title
Implant stability value
Description
resonance frequency analysis using osstell
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients restoring missing maxillary teeth with implant placement.
Both sexes.
Age: 25-45
Mesio-distal dimensions: Not less than 6 mm
Bone Height: Not less than 12 mm
Bucco-lingual dimensions: Not less than 8mm
All measures will be assessed using CBCT.
Exclusion Criteria:
Sites needing bone grafting or augmentation.
Heavy smokers more than 20 cigarettes per day.
Patients with systemic disease that may affect normal healing.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group C ) A Randomized Controlled Clinical Trial
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