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Stability of Dental Implants Placed in Patients With Vitamin D Deficiency Using Sequential Drilling Versus a New One Single Drilling Design

Primary Purpose

Implant Stability With Vitamin D Deficiency

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
sequential drilling technique
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Implant Stability With Vitamin D Deficiency focused on measuring vitamin D, implant stability, sequential drilling, single drilling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. Age: 18-70.
  2. Patient with vitamin D deficiency (< 30 ng/ml )
  3. Patients with single or multiple missed teeth in upper & lower molar premolar area.
  4. Patients with adequate bone volume for the dental implant procedure.
  5. Patient with sufficient interarch space.
  6. Patients who are compliant to oral hygiene measures.
  7. Patient consent approval and signing.

Exclusion criteria:

  1. Systemic disease that contraindicates implant placement or surgical procedures.
  2. Poor patient's compliance.
  3. Psychological problems.
  4. Pathology at the site of intervention.

Sites / Locations

  • Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

implant placement using sequential drilling

implant placement using single drilling

Arm Description

patient with vitamin D deficiency using sequential drilling technique

Patient with vitamin D deficiency using single drilling technique

Outcomes

Primary Outcome Measures

primary/secondary implant stability
primary & secondary implant stability using ostell/periotest

Secondary Outcome Measures

Swelling
post operative swelling questionnaire yes/no
post operative Pain: NRS
post operative pain by numerical rating scale from 0 to 10 , 0 no pain , 10 severe pain
bone resorption
crestal bone resorption :Digital radiography: Digora unit: mm

Full Information

First Posted
September 30, 2018
Last Updated
June 9, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03695562
Brief Title
Stability of Dental Implants Placed in Patients With Vitamin D Deficiency Using Sequential Drilling Versus a New One Single Drilling Design
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
February 14, 2021 (Actual)

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
No

5. Study Description

Brief Summary
- 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
Detailed Description
The high predictability of dental implants has led to routine use with a great expectation for success There are many researches focused on the outcome of delayed dental implant Since the first report of highly success rate after placement of a dental implant there has been increasing interest in this technique for implant treatment The goal of modern dentistry is to restore the patient's dentition to normal contour function comfort esthetics speech and health regardless of the atrophy disease or injury of the stomatognathic system As a result of disease related tooth loss and the value placed upon teeth there has been a continual search for methods by which missing teeth could be replaced Early artificial replacements were made from natural teeth and a variety of substitute materials All transplantation of a tooth from one person to another was an early method by which lost teeth were replaced Archeological discoveries indicate that many ancient civilizations practiced allogenic tooth transplantation. In 1561 Ambrose Pare reported that decayed teeth could be replaced by using extracted teeth from another individual and is credited with being the first to mention transplantation The core objective of dental implant therapy is to improve functional dentition throughout life Nevertheless there are many factors that may effect on implant stability A significant part of implant failure may be related to systemic condition that my retard dental implants osteointegration one of this factors is vitamin D deficiency recently many paper focused on vitamin D deficiency and its impact effect on bone turn over around dental implant There are many different techniques for implant placement even sequential drilling or single drilling technique knowing that single drilling technique has a compression effect which may enhance implant stability however sequential drilling don't have compression effect on bone some paper supported that sequential is much better than single drilling technique however some paper showed there is no clinical significance between two techniques the main idea here that we need to find an ideal technique for implant placement in patients with vitamin D deficiency knowing that vitamin D play an important role for bone turnover around dental implant to attain the required dental implant stability also play a role for osteoblast osteoclast activity Also vitamin D play a role for regulation of parathyroid hormone which play a role for homeostasis of calcium level from bone in blood .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implant Stability With Vitamin D Deficiency
Keywords
vitamin D, implant stability, sequential drilling, single drilling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
implant placement using sequential drilling
Arm Type
Experimental
Arm Description
patient with vitamin D deficiency using sequential drilling technique
Arm Title
implant placement using single drilling
Arm Type
Active Comparator
Arm Description
Patient with vitamin D deficiency using single drilling technique
Intervention Type
Procedure
Intervention Name(s)
sequential drilling technique
Other Intervention Name(s)
conventional implant placement
Intervention Description
Patient with vitamin D deficiency using sequential drilling technique
Primary Outcome Measure Information:
Title
primary/secondary implant stability
Description
primary & secondary implant stability using ostell/periotest
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Swelling
Description
post operative swelling questionnaire yes/no
Time Frame
10 days
Title
post operative Pain: NRS
Description
post operative pain by numerical rating scale from 0 to 10 , 0 no pain , 10 severe pain
Time Frame
10 days
Title
bone resorption
Description
crestal bone resorption :Digital radiography: Digora unit: mm
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr zahran, Phd
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jehan Madkour, Phd
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
i will check with my supervisor
Citations:
PubMed Identifier
26864614
Citation
Merheb J, Temmerman A, Rasmusson L, Kubler A, Thor A, Quirynen M. Influence of Skeletal and Local Bone Density on Dental Implant Stability in Patients with Osteoporosis. Clin Implant Dent Relat Res. 2016 Apr;18(2):253-60. doi: 10.1111/cid.12290. Epub 2016 Feb 10.
Results Reference
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Stability of Dental Implants Placed in Patients With Vitamin D Deficiency Using Sequential Drilling Versus a New One Single Drilling Design

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