Implant Stability With Vitamin D DeficiencyPhase 4NCT03695562
Stability of Dental Implants Placed in Patients With Vitamin D Deficiency Using Sequential Drilling Versus a New One Single Drilling Design
A Phase 4 study testing sequential drilling technique in people with Implant Stability With Vitamin D Deficiency, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Stability With Vitamin D Deficiency
- What is being tested?
- sequential drilling technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 14 Feb 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Systemic disease that contraindicates implant placement or surgical procedures.
- Poor patient's compliance.
- Psychological problems.
- Pathology at the site of intervention.
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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
Read the 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 .
- Being tested
- sequential drilling technique
- Keywords
- vitamin D, implant stability, sequential drilling, single drilling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential drilling techniqueProcedure or surgery
Also called conventional implant placement
Patient with vitamin D deficiency using sequential drilling technique
| Study group | Role | What they receive |
|---|---|---|
| implant placement using sequential drilling | Experimental | patient with vitamin D deficiency using sequential drilling technique Receives: Procedure: sequential drilling technique |
| implant placement using single drilling | Active comparator | Patient with vitamin D deficiency using single drilling technique Receives: Procedure: sequential drilling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary/secondary implant stability
primary \& secondary implant stability using ostell/periotest
Measured: 6 months
Secondary outcomes (3)
Swelling
post operative swelling questionnaire yes/no
Measured: 10 days
post operative Pain: NRS
post operative pain by numerical rating scale from 0 to 10 , 0 no pain , 10 severe pain
Measured: 10 days
bone resorption
crestal bone resorption :Digital radiography: Digora unit: mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Feb 2019
- Primary completion20 Aug 2020
- Study completion14 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant Stability With Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Nabil Ahmed Younis, Cairo University
- Investigators
- Amr zahran, Phd, Study chair, Cairo UniversityJehan Madkour, Phd, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695562
- Sponsor's protocol ID
- perio21005
- Status last verified
- Jun 2021
- First submitted
- 30 Sep 2018
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i will check with my supervisor
Publications
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.
PubMed 26864614
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03695562
- Acronym / sponsor ID
- perio21005
- Keywords
- vitamin D, implant stability, sequential drilling, single drilling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 14 Feb 2021 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implant placement using sequential drilling | Experimental | Procedure: sequential drilling techniquepatient with vitamin D deficiency using sequential drilling technique |
| implant placement using single drilling | Active comparator | Procedure: sequential drilling techniquePatient with vitamin D deficiency using single drilling technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- Systemic disease that contraindicates implant placement or surgical procedures.
- Poor patient's compliance.
- Psychological problems.
- Pathology at the site of intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sequential drilling techniqueAlso: conventional implant placementPatient with vitamin D deficiency using sequential drilling technique | Procedure or surgery | implant placement using sequential drilling, implant placement using single drilling |
Primary outcome
primary/secondary implant stability
Time frame: 6 months
primary \& secondary implant stability using ostell/periotest
3 secondary outcomes
Swelling
Time frame: 10 days
post operative Pain: NRS
Time frame: 10 days
bone resorption
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Results publication: PubMed 26864614Merheb 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.
- Individual participant dataSharing planned: Undecided. i will check with my supervisor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr zahran, Phd study chair
Cairo University
Jehan Madkour, Phd study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sequential drilling technique in people with Implant Stability With Vitamin D Deficiency, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary/secondary implant stability (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.