NCT03716765

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

October 13, 2018

Last Update Submit

October 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • radiographic interproximal bone level

    radiographic interproximal bone level

    6 months

Study Arms (2)

non-surgical periodontal regeneration

EXPERIMENTAL

non-surgical periodontal regeneration using locally injected vitamin d to treat the infrabony defect

Dietary Supplement: locally injected vitamin D

surgical peridoontal regeneration

ACTIVE COMPARATOR

surgical periodontal regeneration using bone graft and collagen barrier

Dietary Supplement: locally injected vitamin D

Interventions

locally injected vitamin DDIETARY_SUPPLEMENT

locally injected vitamin d as non surgical method for periodontal regeneration of vertical bony defects

Also known as: non-surgical periodontal rgeneration
non-surgical periodontal regenerationsurgical peridoontal regeneration

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with infrabony vertical defects
  • systemically free patients
  • periodontally affected patients

You may not qualify if:

  • patients with systemic diseases
  • smokers
  • pregnency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alveolar Bone LossPeriodontal Pocket

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontitis

Study Officials

  • nermin yussif

    Modern Science and Arts University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 23, 2018

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share