NCT05398770

Brief Summary

The purpose of this study is to test the feasibility i. e. to examine all aspects necessary for the implementation of a future randomized clinical trial (RCT) that aims to determine whether non-surgical periodontal treatment can be improved by concomitant intake of vitamin D.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 25, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

May 25, 2022

Last Update Submit

December 11, 2024

Conditions

PeriodontitisPeriodontal DiseasesPeriodontal InflammationInflammationInflammation GumVitamin D

Keywords

Vitamin D25(OH)DCholecalciferolPeriodontitis

Outcome Measures

Primary Outcomes (6)

  • Change in periodontitis status after treatment (2017 case definition)

    Bleeding on probing (BOP)

    Changes from baseline at week 5

  • Change in periodontitis status after treatment (2017 case definition)

    Bleeding on probing (BOP)

    Changes from week 5 to week 11-13

  • Change in periodontitis status after treatment (2017 case definition)

    Bleeding on probing (BOP)

    Changes from baseline at week 11-13

  • Change in periodontitis status after treatment (2017 case definition)

    Probing pocket depths (PPD)

    Changes from baseline at week 5

  • Change in periodontitis status after treatment (2017 case definition)

    Probing pocket depths (PPD)

    Changes from week 5 to week 11-13

  • Change in periodontitis status after treatment (2017 case definition)

    Probing pocket depths (PPD)

    Changes from baseline at week 11-13

Secondary Outcomes (9)

  • Change in 25(OH)D after intervention

    Changes from baseline at week 5

  • Change in 25(OH)D after intervention

    Changes from week 5 to week 11-13

  • Change in 25(OH)D after intervention

    Changes from baseline at week 11-13

  • Change in biomarkers (IL-1β, IL-6, IL-8, IL-12, TNFα, CRP, MCP-1, MMP) over time as response to the intervention

    Changes from baseline at week 5

  • Change in biomarkers (IL-1β, IL-6, IL-8, IL-12, TNFα, CRP, MCP-1, MMP) over time as response to the intervention

    Changes from week 5 to week 11-13

  • +4 more secondary outcomes

Other Outcomes (5)

  • Correlations with biomarkers in blood compared to levels in gingival crevicular fluid

    Correlation at baseline

  • Correlations with biomarkers in blood compared to levels in gingival crevicular fluid

    Correlation at week 5

  • Correlations with biomarkers in blood compared to levels in gingival crevicular fluid

    Correlation at week 11-13

  • +2 more other outcomes

Study Arms (2)

Vitamin D3 (30 µg/d)

EXPERIMENTAL

Subjects will take 30 µg vitamin D3 per day

Dietary Supplement: Vitamin D supplementation (30 µg/d)

Placebo

PLACEBO COMPARATOR

Subjects will take placebo

Dietary Supplement: Vitamin D supplementation (30 µg/d)

Interventions

Vitamin D supplementation (30 µg/d)DIETARY_SUPPLEMENT

The participants will be instructed to take the tablets (vitamin D or placebo) once a day 4 weeks prior to the onset of the non-surgical periodontal treatment (NSPT), and to continue for two weeks after their first NSPT, altogether 6 weeks.

PlaceboVitamin D3 (30 µg/d)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with chronic periodontitis according to the 2017 case definition
  • Adults, age group 20-60 years
  • Periodontitis Stage I-IV (2017 definition)

You may not qualify if:

  • Systemic illnesses (diabetes, osteoporosis)
  • Smoking
  • Immuno-suppressive treatment
  • Pregnancy
  • Daily vit-D supplements
  • Solarium
  • NSPT within 6 months
  • Local anti-microbial treatment
  • No natural teeth/peri implantitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Dental Service Competence Centre of Northern Norway

Tromsø, Postboks 2406, 9271, Norway

Location

MeSH Terms

Conditions

PeriodontitisPeriodontal DiseasesInflammationGingivitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsGingival Diseases

Study Officials

  • Magritt Brustad, Dr. Scient

    Department of Community Medicine, University of Tromso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 1, 2022

Study Start

November 10, 2022

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)