Trial · NCT00779909
Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model
NCT00779909, Early phase 1, Completed, Boston University; results first posted 2017-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model. Trials, record NCT00779909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00779909
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model
- NCT number
- NCT00779909
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 35 participants, actual
- Lead sponsor
- Boston University
- Conditions
- Gingivitis
- Interventions
- vitamin D3, Placebo
- First posted
- 2008-10-24
- Last updated
- 2017-10-02
- Results first posted
- 2017-10-02
- Limitations and caveats
There were recruitment delays due to the potential seasonal impact on vitamin D levels from the sun and the research center was relocated. Both resulted in lower enrollment during the funded time frame than originally projected.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Sites That Bleed on Probing | end of 4 week experimental gingivitis phase | Assessment of the bleeding index will be performed on oral and buccal sites. The periodontal probe will be moved gently across the marginal gingiva of all teeth of a quadrant. After 30 seconds, absence or presence of bleeding will be scored. The number of bleeding sites is used to calculate the gingival bleeding score. |
| Primary | Mandibular Modified Gingival Index (MGI) Score | week 8 and week 12 | The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation. |
| Primary | Maxillary Modified Gingival Index (MGI) Score | week 8 and week 12 | The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation. |
| Secondary | Mandibular Plaque Index (PI) Score | week 8 and week 12 | The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual's score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable. |
| Secondary | Maxillary Plaque Index (PI) Score | week 8 and week 12 | The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual's score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable. |
| Secondary | Gingival Crevicular Fluid (GCF) Volume | week 8 and week 12 | GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device. GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above. |
| Secondary | Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12 | week 8 and week 12 | GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device. GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above. Concentrations of TNF-alpha, IL-1 beta, IL-2, and IL-12 will be measured and means and SDs will be calculated for each study arm. |
| Secondary | Serum Calcium | week 7, week 12 | The serum calcium blood test measures the total calcium in the participants' blood. The normal range for total serum calcium concentration in adults is 8.9-10.2 mg/dL. |
| Secondary | Urinary Calcium/Creatinine Ratio | week 4, week 7, week 12 | Urinary calcium ratios were calculated from urine samples at week 4, 7, and 12. A normal reference interval for the urine calcium (mg/dL):urine creatinine (mg/dL) ratio is \<0.14. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Sites That Bleed on Probing | end of 4 week experimental gingivitis phase | Data for this outcome measure was not collected on any of the participants as it was overlooked and failure to collect these data did not come to the attention of the PI until after all follow-ups were completed. | ||
| PRIMARY | Mandibular Modified Gingival Index (MGI) Score | week 8 and week 12 | units on a scale | MEAN | |
| PRIMARY | Maxillary Modified Gingival Index (MGI) Score | week 8 and week 12 | units on a scale | MEAN | |
| SECONDARY | Mandibular Plaque Index (PI) Score | week 8 and week 12 | units on a scale | MEAN | |
| SECONDARY | Maxillary Plaque Index (PI) Score | week 8 and week 12 | units on a scale | MEAN | |
| SECONDARY | Gingival Crevicular Fluid (GCF) Volume | week 8 and week 12 | ul | MEAN | |
| SECONDARY | Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12 | week 8 and week 12 | pg/site | MEAN | |
| SECONDARY | Serum Calcium | week 7, week 12 | mg/dl | MEAN | |
| SECONDARY | Urinary Calcium/Creatinine Ratio | week 4, week 7, week 12 | ratio | MEAN |
Source ClinicalTrials.gov
Results by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mandibular Modified Gingival Index (MGI) Score | 1- Placebo | 8wk mandibular MGI score | 1.83 | Standard Deviation 0.27 | units on a scale |
| Mandibular Modified Gingival Index (MGI) Score | 2- Vitamin D3, 500 IU | 8wk mandibular MGI score | 1.76 | Standard Deviation 0.46 | units on a scale |
| Mandibular Modified Gingival Index (MGI) Score | 3- Vitamin D3 2500 IU | 8wk mandibular MGI score | 1.62 | Standard Deviation 0.44 | units on a scale |
| Mandibular Modified Gingival Index (MGI) Score | 4- Vitamin D3 5000 IU | 8wk mandibular MGI score | 1.67 | Standard Deviation 0.28 | units on a scale |
| Mandibular Modified Gingival Index (MGI) Score | 1- Placebo | 12wk mandibular MGI score | 2.12 | Standard Deviation 0.14 | units on a scale |
| Mandibular Modified Gingival Index (MGI) Score | 2- Vitamin D3, 500 IU | 12wk mandibular MGI score | 1.97 | Standard Deviation 0.24 | units on a scale |
| Mandibular Modified Gingival Index (MGI) Score | 3- Vitamin D3 2500 IU | 12wk mandibular MGI score | 2.02 | Standard Deviation 0.20 | units on a scale |
| Mandibular Modified Gingival Index (MGI) Score | 4- Vitamin D3 5000 IU | 12wk mandibular MGI score | 2.19 | Standard Deviation 0.15 | units on a scale |
| Maxillary Modified Gingival Index (MGI) Score | 1- Placebo | 8wk maxillary MGI score | 1.78 | Standard Deviation 0.29 | units on a scale |
| Maxillary Modified Gingival Index (MGI) Score | 2- Vitamin D3, 500 IU | 8wk maxillary MGI score | 1.63 | Standard Deviation 0.40 | units on a scale |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1- Placebo | 10 | |
| Overall Study | STARTED | 2- Vitamin D3, 500 IU | 9 | |
| Overall Study | STARTED | 3- Vitamin D3 2500 IU | 8 | |
| Overall Study | STARTED | 4- Vitamin D3 5000 IU | 8 | |
| Overall Study | COMPLETED | 1- Placebo | 9 | |
| Overall Study | COMPLETED | 2- Vitamin D3, 500 IU | 8 | |
| Overall Study | COMPLETED | 3- Vitamin D3 2500 IU | 8 | |
| Overall Study | COMPLETED | 4- Vitamin D3 5000 IU | 7 | |
| Overall Study | NOT COMPLETED | 1- Placebo | 1 | |
| Overall Study | NOT COMPLETED | 2- Vitamin D3, 500 IU | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Joint pain | Musculoskeletal and connective tissue disorders | 1- Placebo | 0 | 9 | |
| other | Joint pain | Musculoskeletal and connective tissue disorders | 2- Vitamin D3, 500 IU | 0 | 8 | |
| other | Joint pain | Musculoskeletal and connective tissue disorders | 3- Vitamin D3 2500 IU | 1 | 8 | |
| other | Joint pain | Musculoskeletal and connective tissue disorders | 4- Vitamin D3 5000 IU | 0 | 7 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1- Placebo | 0 | 9 |
| Total, all-cause mortality | 2- Vitamin D3, 500 IU | 0 | 8 |
| Total, all-cause mortality | 3- Vitamin D3 2500 IU | 0 | 8 |
| Total, all-cause mortality | 4- Vitamin D3 5000 IU | 0 | 7 |
| Total, other adverse events | 1- Placebo | 0 | 9 |
| Total, other adverse events | 2- Vitamin D3, 500 IU | 0 | 8 |
| Total, other adverse events | 3- Vitamin D3 2500 IU | 1 | 8 |
| Total, other adverse events | 4- Vitamin D3 5000 IU | 0 | 7 |
| Total, serious adverse events | 1- Placebo | 0 | 9 |
| Total, serious adverse events | 2- Vitamin D3, 500 IU | 0 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AT003714 | Dose-dependent anti-inflammatory effects of vitamin D in a human gingivitis model | GARCIA, RAUL I | BOSTON UNIVERSITY MEDICAL CAMPUS | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2007 to 2009 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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