| CTRI Number |
CTRI/2010/091/000617 [Registered on: 18/06/2010] |
| Last Modified On: |
10/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Dentistry |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
To study subject with gingivitis and periodontal disease amongst adults in conjunction with analysis of polymorphonuclear leukocytes. |
Scientific Title of Study
Modification(s)
|
Clinical evaluation of oral health parameters amongst adult subjects. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr K V V Prasad |
| Designation |
Professor |
| Affiliation |
|
| Address |
SDM College of Dental Sciences & Hosptial
Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
08362468142 |
| Fax |
08362467612 |
| Email |
kakarlap@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr K V V Prasad |
| Designation |
Professor |
| Affiliation |
|
| Address |
SDM College of Dental Sciences & Hosptial
Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
08362468142 |
| Fax |
08362467612 |
| Email |
kakarlap@hotmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr K V V Prasad |
| Designation |
Professor |
| Affiliation |
|
| Address |
SDM College of Dental Sciences & Hosptial
Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
08362468142 |
| Fax |
08362467612 |
| Email |
kakarlap@hotmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| SDM College of Dental Sciences & hospital,Dharwad |
|
Primary Sponsor
Modification(s)
|
| Name |
SDM College of Dental Sciences Hosptial Dharwad |
| Address |
SDM College of Dental Sciences & Hosptial, Dharwad |
| Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K V V Prasad |
SDM College of Dental Sciences & Hospital |
Sattur,-580009
Dharwad
KARNATAKA |
08362468142
08362467612
kakarlap@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, SDM College of Dental Sciences & Hospital, Dharwad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental plaque, gingivitis and periodontal disease in conjunction with analysis of polymorphonuclear leukocytes |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Colgate Total toothpaste |
Twice daily brushing |
| Comparator Agent |
Colgate Total toothpaste |
Twice daily brushing |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and females in good general health aged 18 to 70 years.
2.A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules.
3.A minimum of 20 natural teeth with facial and lingual scorable surfaces.
4.Adequate oral hygiene and no signs of oral neglect. |
|
| ExclusionCriteria |
| Details |
1.History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars
2.Gagging or other reflexes that prevent oral examination.
3.History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
4.History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
5.Subjects on antibiotic, antiinflammatory or anticoagulant therapy during the month preceding the baseline exam.
6.Significant oral soft tissue pathology, systemically related gingival enlargement, (based on visual examinations).
7.History of active severe periodontal disease with bleeding gums and loose teeth.
8.Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations) will not be included in the tooth count.
9.Fixed or removable orthodontic appliance or removable partial dentures.
10.Participation in a dental plaque/gingivitis clinical study involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the past month.
11.Self reported pregnancy or lactation.
12.History or current use of objects to pierce the lips or tongue.
13.Subjects known to be an alcoholic, or a recovering alcoholic.
14.History or current use of recreational drugs. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| dental plaque, gingivitis and periodontal disease in conjunction with analysis of polymorphonuclear leukocytes |
1 and 2 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
Target Sample Size
Modification(s)
|
Total Sample Size="175"
Sample Size from India="175"
Final Enrollment numbers achieved (Total)= "175"
Final Enrollment numbers achieved (India)="175" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/07/2010 |
| Date of Study Completion (India) |
30/07/2010 |
| Date of First Enrollment (Global) |
01/07/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Title of Study: Clinical evaluation of oral health parameters amongst adult subjects. Investigator: Dr. K.V.V. Prasad Objectives: This study with adult subjects will evaluate clinical parameters of dental plaque, gingivitis and periodontal disease amongst adults in conjunction with analysis of polymorphonuclear leukocytes. Methodology: Prospective subjects will be screened and qualified adults enrolled following a clinical examination. All subjects will be assigned a commercially available fluoride toothpaste and soft-bristled toothbrush for twice daily oral hygiene for the study duration. Subjects will return to the dental clinic for clinical evaluations after 7 and 14 days of use of provided articles. No test products will be provided to subjects. Number of planned patients: Sufficient subjects will be enrolled to ensure one hundred and seventy five (175) subjects will complete all phases of the study. No test products will be provided to subjects. Diagnosis and main criteria for inclusion: Eligible patients include subjects 18 to 70 years of age, in relatively good health. All subjects must be capable of understanding and providing written voluntary consent. Investigational product, dose and mode of administration: Washout Products w/ PLM Numbers: Dentifrice formulation containing MFP (Colgate Cavity Protection, Great Regular Flavor). PIM#: 427679. Duration of treatment: Enrolled subjects will be instructed to discontinue all other oral hygiene formulations and use the provided commercially available fluoride toothpaste for twice daily oral hygiene for a period of 14 days. Analysis: This is a pilot study. Results may be used to design future studies. |