Gingival PigmentationNCT03791957
The Association of Blood Haemoglobin and Colour of Gums
An observational study of Gingival Pigmentation and Gingivitis, run by KLE Society's Institute of Dental Sciences.
Trial summary
AIM: To evaluate the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status SAMPLE SIZE ESTIMATION Done using GPower v.3.1.9.2 Total sample size = 60 (20 each in 3 groups) Effect size = 40% Power = 80% α-error = 5%… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Pigmentation, Gingivitis, Periodontitis
- What is being tested?
- Blood Haemoglobin
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2019to Jan 2020
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore, India
Who may be able to join
- Systemically healthy individuals
- Absence of pathological gingival pigmentation
- Group A - Healthy Periodontium: Absence of clinical signs of inflammation like bleeding on probing, erythema, edema, attachment loss, bone loss, patient symptoms, (bone levels at 1-3mm apical to CEJ)
- Group B - Gingivitis: Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,
- Group C - Periodontitis: Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,periodontal pocketing, clinical attachment loss, radiographically assessed bone loss
Who cannot join
- Tobacco associated pigmentation - smoker's melanosis, chewing/ pouching tobacco
- Pigmentation from exogenous pigments - amalgam tattoo, cultural tattooing, beverages, food colours, betelnut/khat chewing, heavy metals ( mercury, silver, arsenic, bismuth, graphite, lead), topical medications, other foreign bodies
- Pigmentation from endogenous pigments - jaundice, ecchymosis/ petechiae, haemochromatosis, hemosiderin
- Long term consumption of pigmentation causing drugs - ACTH, antimalarial drugs, busulfan, doxorubicin, minocycline, oral contraceptives, phenothiazies
- Syndromes and systemic diseases associated with pigmentation - Addison's disease. Albright's syndrome, basila melanosis, β-thalassemia, healed / healing mucocutaneous lesions, hereditary hemorrhagic Telangiectasia, HIV-associated melanosis, Neurofibromatosis, Peutz Jeghers syndrome, hamartoma, pyogenic granuloma, epulis
- Benign or malignant lesions involving gingival - angiosarcoma, hemangioma, Kaposi's sarcoma, malignant melanoma, melanocytic nevus, pigmented vaculoe
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Association of the Levels of Blood Haemoglobin to the Distribution and Severity of Gingival Melanin Pigmentation at 3 Different Periodontal Health Status
AIM:
To evaluate the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status
Read more
SAMPLE SIZE ESTIMATION
- Done using GPower v.3.1.9.2
- Total sample size = 60 (20 each in 3 groups)
- Effect size = 40%
- Power = 80%
- α-error = 5%
SAMPLING:
- Simple random sampling
- Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore
- Subjects to be categorised into 3 groups (20 subjects each)
- Group A - Healthy periodontium
- Group B - Gingivitis
- Group C - Periodontitis
PARAMETERS ASSESSED
- Blood Haemoglobin Concentration (in %gm/dL)
- Hedin Melanin Index Score 0: No pigmentation Score 1: one or two solitary unit(s) of pigmentation in papillary gingiva without formation of a continuous ribbon between solitary units Score 2: More than three units of pigmentation in papillary gingiva without the formation of a continuous ribbons of pigmentation Score 3: One or more short continuous ribbons of pigmentation Score 4: One continuous ribbon including the entire area between canines
STATISTICAL ANALYSIS
- SPSS for Windows Version 22.0 to be used
- Descriptive statistics: It includes expression of study parameters in terms of Mean \& SD for continuous variables, whereas in terms of frequency and proportions for categorical variables.
- Inferential Statistics:
Chi Square Test will be used to compare the pigmentation index between 03 groups. And similarly, gender wise comparison of hemoglobin concentration will be done using the same test.
One-way ANOVA test followed by Tukey's HSD post hoc Analysis will be used to compare the mean hemoglobin levels based on the pigmentation index scores in each group.
The level of significance [P-Value] was set at P<0.05
- Conditions
- Gingival Pigmentation, Gingivitis, Periodontitis, Healthy
- Being tested
- Blood Haemoglobin
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood HaemoglobinOther
Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood
| Study group | Role | What they receive |
|---|---|---|
| Group A - Healthy Periodontium | Absence of clinical signs of inflammation like bleeding on probing, erythema, edema, attachment loss, bone loss, patient symptoms, (bone levels at 1-3mm apical to CEJ) n=20 Receives: Other: Blood Haemoglobin | |
| Group B - Gingivitis | Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla, n=20 Receives: Other: Blood Haemoglobin | |
| Group C - Periodontitis | Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,periodontal pocketing, clinical attachment loss, radiographically assessed bone loss n=20 Receives: Other: Blood Haemoglobin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Haemoglobin to Melanin pigmentation
To assess the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status by Hedin Melanin Index both by intragroup comparison within each of the 3 groups and intergroup comparison between the three groups
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start20 Dec 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PigmentationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- KLE Society's Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Riya Achamma Daniel, KLE Society's Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791957
- Sponsor's protocol ID
- riya2pigmentation
- Status last verified
- Dec 2019
- First submitted
- 30 Dec 2018
- Last updated
- 17 Dec 2019
- 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 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of the Levels of Blood Haemoglobin to the Distribution and Severity of Gingival Melanin Pigmentation at 3 Different Periodontal Health Status
- ClinicalTrials.gov ID
- NCT03791957
- Acronym / sponsor ID
- riya2pigmentation
- Conditions
- Gingival Pigmentation, Gingivitis, Periodontitis, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KLE Society's Institute of Dental SciencesUniversity, hospital or other
- Study start
- 20 Dec 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 3 Jan 2019 (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.
AIM:
To evaluate the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status
SAMPLE SIZE ESTIMATION
- Done using GPower v.3.1.9.2
- Total sample size = 60 (20 each in 3 groups)
- Effect size = 40%
- Power = 80%
- α-error = 5%
SAMPLING:
- Simple random sampling
- Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore
- Subjects to be categorised into 3 groups (20 subjects each)
- Group A - Healthy periodontium
- Group B - Gingivitis
- Group C - Periodontitis
PARAMETERS ASSESSED
- Blood Haemoglobin Concentration (in %gm/dL)
- Hedin Melanin Index Score 0: No pigmentation Score 1: one or two solitary unit(s) of pigmentation in papillary gingiva without formation of a continuous ribbon between solitary units Score 2: More than three units of pigmentation in papillary gingiva without the formation of a continuous ribbons of pigmentation Score 3: One or more short continuous ribbons of pigmentation Score 4: One continuous ribbon including the entire area between canines
STATISTICAL ANALYSIS
- SPSS for Windows Version 22.0 to be used
- Descriptive statistics: It includes expression of study parameters in terms of Mean \& SD for continuous variables, whereas in terms of frequency and proportions for categorical variables.
- Inferential Statistics:
Chi Square Test will be used to compare the pigmentation index between 03 groups. And similarly, gender wise comparison of hemoglobin concentration will be done using the same test.
One-way ANOVA test followed by Tukey's HSD post hoc Analysis will be used to compare the mean hemoglobin levels based on the pigmentation index scores in each group.
The level of significance [P-Value] was set at P<0.05
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Healthy Periodontium | – | Other: Blood HaemoglobinAbsence of clinical signs of inflammation like bleeding on probing, erythema, edema, attachment loss, bone loss, patient symptoms, (bone levels at 1-3mm apical to CEJ) n=20 |
| Group B - Gingivitis | – | Other: Blood HaemoglobinPresence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla, n=20 |
| Group C - Periodontitis | – | Other: Blood HaemoglobinPresence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,periodontal pocketing, clinical attachment loss, radiographically assessed bone loss n=20 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore, India
Key inclusion criteria (5 listed)
- Systemically healthy individuals
- Absence of pathological gingival pigmentation
Key exclusion criteria (6 listed)
- Tobacco associated pigmentation - smoker's melanosis, chewing/ pouching tobacco
- Pigmentation from exogenous pigments - amalgam tattoo, cultural tattooing, beverages, food colours, betelnut/khat chewing, heavy metals ( mercury, silver, arsenic, bismuth, graphite, lead), topical medications, other foreign bodies
- Pigmentation from endogenous pigments - jaundice, ecchymosis/ petechiae, haemochromatosis, hemosiderin
- Long term consumption of pigmentation causing drugs - ACTH, antimalarial drugs, busulfan, doxorubicin, minocycline, oral contraceptives, phenothiazies
- Syndromes and systemic diseases associated with pigmentation - Addison's disease. Albright's syndrome, basila melanosis, β-thalassemia, healed / healing mucocutaneous lesions, hereditary hemorrhagic Telangiectasia, HIV-associated melanosis, Neurofibromatosis, Peutz Jeghers syndrome, hamartoma, pyogenic granuloma, epulis
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 |
|---|---|---|
| Blood HaemoglobinRoutine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood | Other | Group A - Healthy Periodontium, Group B - Gingivitis, Group C - Periodontitis |
Primary outcome
Blood Haemoglobin to Melanin pigmentation
Time frame: Baseline
To assess the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status by Hedin Melanin Index both by intragroup comparison within each of the 3 groups and intergroup comparison between the three groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Pigmentation and Gingivitis, run by KLE Society's Institute of Dental Sciences.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riya A Daniel, BDS, PG student (9444140560 ext. +91, riyaad.rd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Haemoglobin to Melanin pigmentation (time frame: Baseline). 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 17 Dec 2019.