GingivitisEarly Phase 1NCT00779909
Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model
A Early Phase 1 study testing vitamin D3 in people with Gingivitis, run by Boston University at 1 site in United States.
Trial summary
The burden of chronic gingivitis and periodontitis in the US is disproportionately high among Non-Hispanic Blacks compared to Non-Hispanic Whites. Chronic gingivitis is a highly prevalent chronic inflammatory disease that may progress into periodontitis, a major cause of tooth loss, Data from in-vitro and animal… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Sep 2011
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- informed written consent
- healthy subjects age 18-64 years old
- serum 25-hydroxyvitamin D concentration <62.5 nmol/L (<25 ng/mL)
Who cannot join
- increased risk for infectious endocarditis that require antibiotic prophylaxis prior to periodontal probing
- women who are postmenopausal
- pregnancy or planned pregnancy within the period of the trial
- Periodontitis (attachment loss ≥4 mm and probing depths≥5 mm on at least one interproximal site)
- Any need for immediate dental treatment (can be eligible after completion of treatment)
- history of hypercalcemia, malabsorption syndrome, abnormal sensitivity to vitamin D or hypervitaminosis D
Show all 20Show fewer
- < 3 teeth with bleeding on probing
- < 20 teeth present or <8 interproximal spaces (i.e., papillae) in upper jaw
- mean plaque index > 3
- Current smoking or former smoking with cessation <5 years ago
- regular use of any medication for prevention or treatment of disease (including Aspirin, NSAIDs, corticosteroids, but NOT including contraceptives)
- Diabetes mellitus
- hypercalcemia (serum calcium > ULN),
- hypocalcemia (serum calcium < ULN),
- hyperparathyroidism (serum PTH concentration > ULN),
- hypoparathyroidism (serum PTH concentration < LLN)
- any cardiac rhythm abnormalities on baseline ECG
- use of tanning beds/unwillingness to abstain from use of tanning beds during study
- planned travel during study period / unwillingness to abstain from travel to the South or High Altitudes
- unwillingness to abstain from use of any supplements (including vitamin/mineral and herbal supplements) during study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Goldman School of Dental Medicine
Boston, Massachusetts, 02118
About this study
The burden of chronic gingivitis and periodontitis in the US is disproportionately high among Non-Hispanic Blacks compared to Non-Hispanic Whites. Chronic gingivitis is a highly prevalent chronic inflammatory disease that may progress into periodontitis, a major cause of tooth loss, Data from in-vitro and animal studies suggest anti-inflammatory effects of vitamin D; however, if and over what dose-range vitamin D may have anti-inflammatory effects in humans is uncertain. Recent clinical studies indicate that beneficial effects of vitamin D for several important outcomes may occur over a wide range of serum 25-hydroxyvitamin D (25-OHD) concentrations, possibly up to concentrations that would require vitamin D intakes ranging from 2 to more than 10 ten times higher than the current RDA for vitamin D. Because dark skin pigmentation is a potent inhibitor of vitamin D photosynthesis, Non-Hispanic Blacks have much lower 25-OHD serum levels than Non-Hispanic Whites. These differences in vitamin D status may partially explain the racial disparities in prevalence of chronic gingivitis and periodontitis observed in the US.
We hypothesize that oral cholecalciferol supplementation can reduce susceptibility to gingivitis over a wide range of serum 25-OHD concentrations in Non-Hispanic Whites and Non-Hispanic Blacks. We propose to conduct a simple, single-center, randomized, double-blind, placebo-controlled parallel-group dose-ranging study. We will compare placebo to doses of 500 IU, 2,500 IU and 5,000 IU vitamin D3 per day. We will compare the severity of gingival inflammation that develops in response to a 28-day period of unlimited plaque growth (experimental gingivitis) between dosage groups. Furthermore, we will evaluate the association between achieved 25-OHD levels and gingival inflammation.
The results of this study will have several important implications, as dietary vitamin D supplementation may be a simple, safe and inexpensive means by which to reduce racial/ethnic disparities in gingivitis, as well as to reduce the overall burden of oral disease in the population as a whole. The study will elucidate the dose-response relationship of the anti-inflammatory effects of vitamin D, which in turn may lead to a revision of the current recommendations regarding nutritional supplementation of vitamin D in order to optimize the prevention of important medical conditions and diseases and reduce racial health disparities.
Read the detailed description
Vitamin D is important for healthy bones. More recently, anti-inflammatory effects of vitamin D have been found in laboratory and animal studies and vitamin D may be beneficial for inflammatory diseases. Gingivitis is a common inflammatory disease of the gums that develops in response to bacterial components in dental plaque. The degree to which gingivitis develops in response to a given amount of plaque may vary between different individuals. With this study, we want to investigate whether oral supplementation with vitamin D can reduce the susceptibility to gingivitis in non-Hispanic Whites and African Americans.
We plan to randomize 120 healthy volunteers (60 Non-Hispanic Whites, 60 Non-Hispanic Blacks) during the wintertime who will abstain from oral hygiene measures (brushing, flossing or antiseptic mouth rinses) for a period of 4 weeks to allow accumulation of plaque and development of gingivitis. These subjects will be randomly allocated to receive either oral supplementation with placebo, 500 IU, 2500 IU or 5000 IU vitamin D3 per day starting 8 weeks prior to the experimental gingivitis period for a total of 12 weeks. The development of gingivitis will be measured using clinical indices of gingival inflammation, inflammatory biomarker in gingival crevicular fluid (GCF) and GCF volume. Before and after completion of the experimental gingivitis phase, all subjects will receive a professional cleaning of their teeth to ensure complete resolution of inflammation.Blood samples will be collected at the screening examination, baseline, week 7, and after week 12 (end of trial) to determine serum levels of 25-hydroxyvitamin D, parathyroid hormone , serum calcium and to archive serum and plasma samples. In addition urine samples will be collected at baseline and weeks 4,7 and 12 to determine calcium excretion and to archive urine samples for future analyses. Mandibular and maxillary Modified Gingival Index (MGI) Scores, Plaque Index (PI) scores, and GCF sampling to measure volume and assess for biomarkers (TNF-LPH, IL-1 beta, IL-2, IL-12) will be done at 8 and 12 weeks.
Following recruitment and consent those subjects deemed eligible for further screening will then be referred to the BUMC GCRC in order to have two components of the screening procedure performed:Electrocardiogram and a blood draw to be sent to Quest for analysis of Vit D and PTH levels.
The extent to which gingivitis develops during the 4-week period of plaque accumulation will be compared between the two experimental groups. Furthermore, we will evaluate the association between serum levels of 25-OHD and the development of gingivitis as well as serum markers of inflammation.
- Conditions
- Gingivitis
- Being tested
- vitamin D3, Placebo
- Keywords
- vitamin D, gingivitis, periodontal disease, inflammation
- Medical subject headings
- Gingivitis, Periodontal Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Drug
Also called cholecalciferol
oral supplementation once per day for 12 weeks of different daily doses: 500 IU, 2500 IU, or 5000 IU after abstaining from oral hygiene measures (brushing, flossing or antiseptic mouth rinses) for a period of 4 weeks to allow accumulation of plaque and development of experimental gingivitis.
PlaceboOther
Also called sugar pill
oral supplementation once per day for 12 weeks of a sugar pill after abstaining from oral hygiene measures (brushing, flossing or antiseptic mouth rinses) for a period of 4 weeks to allow accumulation of plaque and development of experimental gingivitis.
| Study group | Role | What they receive |
|---|---|---|
| 1- Placebo | Placebo comparator | placebo capsule once per day Receives: Other: Placebo |
| 2- Vitamin D3, 500 IU | Experimental | vitamin D3, 500 IU capsule once per day Receives: Drug: vitamin D3 |
| 3- Vitamin D3, 2500 IU | Experimental | vitamin D3, 2500 IU capsule once per day Receives: Drug: vitamin D3 |
| 4- Vitamin D3, 5000 IU | Experimental | vitamin D3, 5000 IU capsule once per day Receives: Drug: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Sites That Bleed on Probing
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.
Measured: end of 4 week experimental gingivitis phase
Mandibular Modified Gingival Index (MGI) Score
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.
Measured: week 8 and week 12
Maxillary Modified Gingival Index (MGI) Score
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.
Measured: week 8 and week 12
Secondary outcomes (6)
Mandibular Plaque Index (PI) Score
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.
Measured: week 8 and week 12
Maxillary Plaque Index (PI) Score
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.
Measured: week 8 and week 12
Gingival Crevicular Fluid (GCF) Volume
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.
Measured: week 8 and week 12
Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-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.
Measured: week 8 and week 12
Serum Calcium
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.
Measured: week 7, week 12
Urinary Calcium/Creatinine Ratio
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.
Measured: week 4, week 7, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Boston 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Raul I Garcia, DMD, Principal investigator, Boston University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779909
- Sponsor's protocol ID
- H-26461
- Other IDs
- R21AT003714-01
- Status last verified
- Aug 2017
- First submitted
- 22 Oct 2008
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model
- ClinicalTrials.gov ID
- NCT00779909
- Acronym / sponsor ID
- H-26461
- Conditions
- Gingivitis
- Keywords
- vitamin D, gingivitis, periodontal disease, inflammation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Dec 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 2 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The burden of chronic gingivitis and periodontitis in the US is disproportionately high among Non-Hispanic Blacks compared to Non-Hispanic Whites. Chronic gingivitis is a highly prevalent chronic inflammatory disease that may progress into periodontitis, a major cause of tooth loss, Data from in-vitro and animal studies suggest anti-inflammatory effects of vitamin D; however, if and over what dose-range vitamin D may have anti-inflammatory effects in humans is uncertain. Recent clinical studies indicate that beneficial effects of vitamin D for several important outcomes may occur over a wide range of serum 25-hydroxyvitamin D (25-OHD) concentrations, possibly up to concentrations that would require vitamin D intakes ranging from 2 to more than 10 ten times higher than the current RDA for vitamin D. Because dark skin pigmentation is a potent inhibitor of vitamin D photosynthesis, Non-Hispanic Blacks have much lower 25-OHD serum levels than Non-Hispanic Whites. These differences in vitamin D status may partially explain the racial disparities in prevalence of chronic gingivitis and periodontitis observed in the US.
We hypothesize that oral cholecalciferol supplementation can reduce susceptibility to gingivitis over a wide range of serum 25-OHD concentrations in Non-Hispanic Whites and Non-Hispanic Blacks. We propose to conduct a simple, single-center, randomized, double-blind, placebo-controlled parallel-group dose-ranging study. We will compare placebo to doses of 500 IU, 2,500 IU and 5,000 IU vitamin D3 per day. We will compare the severity of gingival inflammation that develops in response to a 28-day period of unlimited plaque growth (experimental gingivitis) between dosage groups. Furthermore, we will evaluate the association between achieved 25-OHD levels and gingival inflammation.
The results of this study will have several important implications, as dietary vitamin D supplementation may be a simple, safe and inexpensive means by which to reduce racial/ethnic disparities in gingivitis, as well as to reduce the overall burden of oral disease in the population as a whole. The study will elucidate the dose-response relationship of the anti-inflammatory effects of vitamin D, which in turn may lead to a revision of the current recommendations regarding nutritional supplementation of vitamin D in order to optimize the prevention of important medical conditions and diseases and reduce racial health disparities.
Detailed description
Vitamin D is important for healthy bones. More recently, anti-inflammatory effects of vitamin D have been found in laboratory and animal studies and vitamin D may be beneficial for inflammatory diseases. Gingivitis is a common inflammatory disease of the gums that develops in response to bacterial components in dental plaque. The degree to which gingivitis develops in response to a given amount of plaque may vary between different individuals. With this study, we want to investigate whether oral supplementation with vitamin D can reduce the susceptibility to gingivitis in non-Hispanic Whites and African Americans.
We plan to randomize 120 healthy volunteers (60 Non-Hispanic Whites, 60 Non-Hispanic Blacks) during the wintertime who will abstain from oral hygiene measures (brushing, flossing or antiseptic mouth rinses) for a period of 4 weeks to allow accumulation of plaque and development of gingivitis. These subjects will be randomly allocated to receive either oral supplementation with placebo, 500 IU, 2500 IU or 5000 IU vitamin D3 per day starting 8 weeks prior to the experimental gingivitis period for a total of 12 weeks. The development of gingivitis will be measured using clinical indices of gingival inflammation, inflammatory biomarker in gingival crevicular fluid (GCF) and GCF volume. Before and after completion of the experimental gingivitis phase, all subjects will receive a professional cleaning of their teeth to ensure complete resolution of inflammation.Blood samples will be collected at the screening examination, baseline, week 7, and after week 12 (end of trial) to determine serum levels of 25-hydroxyvitamin D, parathyroid hormone , serum calcium and to archive serum and plasma samples. In addition urine samples will be collected at baseline and weeks 4,7 and 12 to determine calcium excretion and to archive urine samples for future analyses. Mandibular and maxillary Modified Gingival Index (MGI) Scores, Plaque Index (PI) scores, and GCF sampling to measure volume and assess for biomarkers (TNF-LPH, IL-1 beta, IL-2, IL-12) will be done at 8 and 12 weeks.
Following recruitment and consent those subjects deemed eligible for further screening will then be referred to the BUMC GCRC in order to have two components of the screening procedure performed:Electrocardiogram and a blood draw to be sent to Quest for analysis of Vit D and PTH levels.
The extent to which gingivitis develops during the 4-week period of plaque accumulation will be compared between the two experimental groups. Furthermore, we will evaluate the association between serum levels of 25-OHD and the development of gingivitis as well as serum markers of inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1- Placebo | Placebo comparator | Other: Placeboplacebo capsule once per day |
| 2- Vitamin D3, 500 IU | Experimental | Drug: vitamin D3vitamin D3, 500 IU capsule once per day |
| 3- Vitamin D3, 2500 IU | Experimental | Drug: vitamin D3vitamin D3, 2500 IU capsule once per day |
| 4- Vitamin D3, 5000 IU | Experimental | Drug: vitamin D3vitamin D3, 5000 IU capsule once per day |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- informed written consent
- healthy subjects age 18-64 years old
- serum 25-hydroxyvitamin D concentration <62.5 nmol/L (<25 ng/mL)
Key exclusion criteria (20 listed)
- increased risk for infectious endocarditis that require antibiotic prophylaxis prior to periodontal probing
- women who are postmenopausal
- pregnancy or planned pregnancy within the period of the trial
- Periodontitis (attachment loss ≥4 mm and probing depths≥5 mm on at least one interproximal site)
- Any need for immediate dental treatment (can be eligible after completion of treatment)
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 |
|---|---|---|
| vitamin D3Also: cholecalciferoloral supplementation once per day for 12 weeks of different daily doses: 500 IU, 2500 IU, or 5000 IU after abstaining from oral hygiene measures (brushing, flossing or antiseptic mouth rinses) for a period of 4 weeks to allow accumulation of plaque and development of experimental gingivitis. | Drug | 2- Vitamin D3, 500 IU, 3- Vitamin D3, 2500 IU, 4- Vitamin D3, 5000 IU |
| PlaceboAlso: sugar pilloral supplementation once per day for 12 weeks of a sugar pill after abstaining from oral hygiene measures (brushing, flossing or antiseptic mouth rinses) for a period of 4 weeks to allow accumulation of plaque and development of experimental gingivitis. | Other | 1- Placebo |
Primary outcome
Proportion of Sites That Bleed on Probing
Time frame: 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.
Mandibular Modified Gingival Index (MGI) Score
Time frame: 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.
Maxillary Modified Gingival Index (MGI) Score
Time frame: 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.
6 secondary outcomes
Mandibular Plaque Index (PI) Score
Time frame: week 8 and week 12
Maxillary Plaque Index (PI) Score
Time frame: week 8 and week 12
Gingival Crevicular Fluid (GCF) Volume
Time frame: week 8 and week 12
Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12
Time frame: week 8 and week 12
Serum Calcium
Time frame: week 7, week 12
Urinary Calcium/Creatinine Ratio
Time frame: week 4, week 7, week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Raul I Garcia, DMD principal investigator
Boston University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing vitamin D3 in people with Gingivitis, run by Boston University at 1 site in United States.
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 20 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 2 Oct 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Sites That Bleed on Probing (time frame: end of 4 week experimental gingivitis phase). The study lists 3 primary outcomes in all. 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 2 Oct 2017.