- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03695562
Stability of Dental Implants Placed in Patients With Vitamin D Deficiency Using Sequential Drilling Versus a New One Single Drilling Design
Stability of Dental Implants Placed in Patients With Vitamin D Deficiency Using Sequential Drilling Versus a New One Single Drilling Design: A Randomized Clinical Trial
- Vitamin D considers as the most potent effect on calcium level in blood it was found that vitamin D target mainly bone tissue intestine and kidney for calcium absorption In bone, vitamin D stimulates mainly the activity of osteoclasts osteoblast activity on the other hand it increases the production of extracellular matrix proteins by different osteoblastic activity. Vitamin D also increase intestinal calcium absorption and regulate synthesis and secretion of parathyroid hormone (PTH)
Implant consider as one of the most successful treatment modalities that usually used in dental clinics for restoring single or multiple missed teeth knowing that successful rate of dental implant may reach up to 99% however there are many different techniques for implant placement they mainly depend on the same procedure for implant placement even sequential drilling technique or single drilling technique some paper supported that sequential drilling is much better than single drilling technique on other hand some assume that single drilling is much better as it save time effort material less bone trauma & less heat generation although there are many studies performed on sequential drilling & single drilling techniques we still have a gap for understanding the ideal technique for implant placement in patients with vitamin D deficiency
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Cairo, Egypt
- Cairo University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Age: 18-70.
- Patient with vitamin D deficiency (< 30 ng/ml )
- Patients with single or multiple missed teeth in upper & lower molar premolar area.
- Patients with adequate bone volume for the dental implant procedure.
- Patient with sufficient interarch space.
- Patients who are compliant to oral hygiene measures.
- Patient consent approval and signing.
Exclusion criteria:
- Systemic disease that contraindicates implant placement or surgical procedures.
- Poor patient's compliance.
- Psychological problems.
- Pathology at the site of intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: implant placement using sequential drilling
patient with vitamin D deficiency using sequential drilling technique
|
Patient with vitamin D deficiency using sequential drilling technique
Other Names:
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Active Comparator: implant placement using single drilling
Patient with vitamin D deficiency using single drilling technique
|
Patient with vitamin D deficiency using sequential drilling technique
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary/secondary implant stability
Time Frame: 6 months
|
primary & secondary implant stability using ostell/periotest
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swelling
Time Frame: 10 days
|
post operative swelling questionnaire yes/no
|
10 days
|
post operative Pain: NRS
Time Frame: 10 days
|
post operative pain by numerical rating scale from 0 to 10 , 0 no pain , 10 severe pain
|
10 days
|
bone resorption
Time Frame: 6 months
|
crestal bone resorption :Digital radiography: Digora unit: mm
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jehan Madkour, Phd, Cairo University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- perio21005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Implant Stability With Vitamin D Deficiency
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Ain Shams UniversityRecruitingVitamin D Deficiency | Dental Implant Failure NosEgypt
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University Hospital, Clermont-FerrandTerminated
-
Rajavithi HospitalQueen Sirikit National Institute of Child HealthCompleted
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Universidade de Passo FundoUnknownDeficiency, Vitamin DBrazil
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Federal University of Rio Grande do SulCompletedDeficiency, Vitamin DBrazil
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Nutrition Institute, SloveniaEuropean Regional Development Fund; Vizera d.o.o.; Frutarom Etol d.o.o.CompletedVitamin B 12 Deficiency | Vitamin d Deficiency | Protein DeficiencySlovenia
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Wageningen UniversityDSM Nutritional Products, Inc.; Top Institute Food and NutritionCompletedElderly, Frail | Deficiency, Vitamin DNetherlands
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University of PaviaIstituti Clinici Scientifici Maugeri SpAUnknownVitamin D Deficiency | Vitamin D3 Deficiency | Vitamin DItaly
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingVitamin d DeficiencyChina
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Okan UniversityArçelik A.Ş.Completed
Clinical Trials on sequential drilling technique
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Mansoura UniversityActive, not recruiting
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Second Affiliated Hospital, School of Medicine,...Ningbo Medical Center Lihuili Hospital; The First People's Hospital of Huzhou; Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University and other collaboratorsNot yet recruitingAnterior Cruciate Ligament InjuriesChina
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Cairo UniversityNot yet recruiting
-
Clinique Dentaire et d'implantologie Dr.Vinh NguyenGoethe UniversityCompleted
-
Krishnadevaraya College of Dental Sciences & HospitalCompletedBone Density | Implant StabilityIndia
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Prince of Songkla UniversityCompletedAngle Closure GlaucomaThailand
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University of IndianapolisUnknownSpinal Nerve Root Disorder NosUnited States
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Cairo UniversityRecruiting
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Arab American University (Palestine)CompletedImplant TherapyPalestinian Territory, occupied
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Mohammed RamadanNot yet recruitingSingle Tooth Lost | Partially Edentulous MaxillaEgypt