Periodontal Bone LossNCT03716765
Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects
A study testing locally injected vitamin D in people with Periodontal Bone Loss and Periodontal Pocket, run by Cairo University.
Trial summary
vitamin D has great role in bone regenration and soft tissue health. in the past periodontal regeneration was performed using bone graft and barrier membrane Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Bone Loss, Periodontal Pocket
- What is being tested?
- locally injected vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2018
- Phase
- Interventional
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with infrabony vertical defects
- systemically free patients
- periodontally affected patients
Who cannot join
- patients with systemic diseases
- smokers
- pregnency
About this study
Official title: Locally Injected Vitamin D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects: Prospective Study
vitamin D has great role in bone regenration and soft tissue health. in the past periodontal regeneration was performed using bone graft and barrier membrane
Read the detailed description
there was no previous studies used the locally injected vitamin d in periodontal regeneration. therefore, we intended to study the effect of locally injected vitamin D in peridoontal regerneration in comparison with the conventional surgical technique
- Conditions
- Periodontal Bone Loss, Periodontal Pocket
- Being tested
- locally injected vitamin D
- Medical subject headings
- Alveolar Bone Loss, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
locally injected vitamin DDietary supplement
Also called non-surgical periodontal rgeneration
locally injected vitamin d as non surgical method for periodontal regeneration of vertical bony defects
| Study group | Role | What they receive |
|---|---|---|
| non-surgical periodontal regeneration | Experimental | non-surgical periodontal regeneration using locally injected vitamin d to treat the infrabony defect Receives: Dietary Supplement: locally injected vitamin D |
| surgical peridoontal regeneration | Active comparator | surgical periodontal regeneration using bone graft and collagen barrier Receives: Dietary Supplement: locally injected vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic interproximal bone level
radiographic interproximal bone level
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 posted23 Oct 2018
- Study startJan 2016
- Primary completionJan 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Bone LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nermin mohammed ahmed yussif, Cairo University
- Investigators
- nermin yussif, Study director, Modern Science and Arts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716765
- Sponsor's protocol ID
- 1236
- Status last verified
- Oct 2018
- First submitted
- 13 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locally Injected Vitamin D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects: Prospective Study
- ClinicalTrials.gov ID
- NCT03716765
- Acronym / sponsor ID
- 1236
- Conditions
- Periodontal Bone Loss, Periodontal Pocket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 23 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 has great role in bone regenration and soft tissue health. in the past periodontal regeneration was performed using bone graft and barrier membrane
Detailed description
there was no previous studies used the locally injected vitamin d in periodontal regeneration. therefore, we intended to study the effect of locally injected vitamin D in peridoontal regerneration in comparison with the conventional surgical technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-surgical periodontal regeneration | Experimental | Dietary Supplement: locally injected vitamin Dnon-surgical periodontal regeneration using locally injected vitamin d to treat the infrabony defect |
| surgical peridoontal regeneration | Active comparator | Dietary Supplement: locally injected vitamin Dsurgical periodontal regeneration using bone graft and collagen barrier |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with infrabony vertical defects
- systemically free patients
- periodontally affected patients
Key exclusion criteria (3 listed)
- patients with systemic diseases
- smokers
- pregnency
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 |
|---|---|---|
| locally injected vitamin DAlso: non-surgical periodontal rgenerationlocally injected vitamin d as non surgical method for periodontal regeneration of vertical bony defects | Dietary supplement | non-surgical periodontal regeneration, surgical peridoontal regeneration |
Primary outcome
radiographic interproximal bone level
Time frame: 6 months
radiographic interproximal bone level
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 23 Oct 2018.
- Individual participant dataSharing planned: No
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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.
nermin yussif study director
Modern Science and Arts University
Questions about this trial
What is this clinical trial studying?
A study testing locally injected vitamin D in people with Periodontal Bone Loss and Periodontal Pocket, run by Cairo University.
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 3 inclusion and 3 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
radiographic interproximal bone level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2018.