| CTRI Number |
CTRI/2025/04/084782 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing two different methods for measuring changes in color of the gums after scaling treatment. |
|
Scientific Title of Study
|
Comparative evaluation of two different systems of photometric analysis in the quantification of gingival color changes in patients undergoing scaling and root planing. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Jyothi Sarpangala |
| Designation |
Post graduate Student |
| Affiliation |
KLE Societys Institute of Dental Sciences |
| Address |
Department of Periodontics, Room number 5,
KLE Societys Institute of Dental Sciences,
20, Tumkur road,
Yeshwanthpur suburb II stage,
Raja Industrial Estate,
Yeshwanthpur, Bengaluru,
Karnataka,
560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9108767689 |
| Fax |
|
| Email |
djyothi2698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena H R |
| Designation |
Professor |
| Affiliation |
KLE Societys Institute of Dental Sciences |
| Address |
Department of Periodontics, Room no 5,
KLE Societys Institute of Dental Sciences,
20, Tumkur road,
Yeshwanthpur suburb II stage,
Raja Industrial Estate,
Yeshwanthpur, Bengaluru,
Karnataka,
560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9480516011 |
| Fax |
|
| Email |
drveenahr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Jyothi Sarpangala |
| Designation |
Post graduate Student |
| Affiliation |
KLE Societys Institute of Dental Sciences |
| Address |
Department of periodontics, Room no 5,
KLE Societys Institute of Dental Sciences,
20, Tumkur road,
Yeshwanthpur suburb II stage,
Raja Industrial Estate,
Yeshwanthpur, Bengaluru,
Karnataka,
560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9108767689 |
| Fax |
|
| Email |
djyothi2698@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Societys Institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
Dr Divya Jyothi Sarpangala |
| Address |
Department of Periodontics, Room no 5, KLE Societys Institute of Dental Sciences,
20, Tumkur road, Yeshwanthpur suburb II stage,
Raja Industrial Estate,
Yeshwanthpur,
Bengaluru, 570022 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Jyothi Sarpangala |
KLE societys institute of dental sciences |
Room no 5, Department of Periodontics, KLE Societys Institute of Dental Sciences,
20, Tumkur road,
Yeshwanthpur suburb II stage,
Raja Industrial estate,
Yeshwanthpur, Bengaluru,
Karnataka, 560022
Bangalore
KARNATAKA |
9108767689
djyothi2698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Societys Institute of Dental Sciences Communication of Decision of the Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, (2) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
GROUP 1:
1. Systemically healthy male and female subjects at the age of 20 years to 60 years.
2. Presence of a minimum of 20 teeth in the oral cavity
3. Generalized gingivitis (Dental biofilm induced as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology(AAP))
GROUP 2:
1. Systemically healthy male and female subjects in the age group of 20 to 60 years.
2. Presence of a minimum of 20 teeth in the oral cavity.
3. Generalized periodontitis I stage 3 grade B as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions and published by the American Academy of Periodontology (AAP)
GROUP 3
1. Systemically healthy male and female subjects in the age group of 20 to 60 years.
2. Presence of a minimum of 20 teeth in the oral cavity.
3. Periodontally healthy control i.e. clinically healthy gingiva with intact periodontium characterized as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP)
|
|
| ExclusionCriteria |
| Details |
1. Subjects with a history of periodontal therapy in any form six months prior to their recruitment to the study.
2. Current consumers of alcohol and tobacco.
3. Pregnant and lactating women
4. Patients with a history of medications (Systemic and topical) and conditions that may affect the color of gingiva.
5. Patients with pathological pigmentation of gingiva.
6. Patients consuming foods with additives that may effect the color of gingiva. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival color changes obtained from digital photographs using HSB color space and CIELab color space before and after scaling and root planing. |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival index, Plaque index, Probing pocket depth, Clinical attachment loss. |
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION: Experimental gingivitis studies provided the first empiric evidence that the accumulation of microbial biofilm on clean tooth surfaces results in an inflammatory process in gingival tissues. Gingival and periodontal indices are used to assess the inflammatory changes in the gingiva and are considered the gold standard in the assessment of clinical outcomes. To the best of our knowledge, there are no direct indices to measure color changes in the gingiva. AIM: To compare two different systems of digital photometric analysis (HSB color space and CIELab color space) to quantify gingival color changes in patients before and after scaling and root planing (SRP). OBJECTIVES: To compare the color space values in the assessment of gingival color changes obtained using HSB and CIELab from digital photographs before and after scaling and root planing and to acertain the correlation if any, of gingival color changes quantified using photometric analysis with scores of other clinical indices used to assess the severity of gingival inflammation. METHODOLOGY: The study will include patients of both genders in the age group of 20-60 years from the outpatient pool of the Department of Periodontics, KLE Society’s Institute of Dental Sciences, Banglore. A total sample of 75 individuals will be divided among 3 groups of 25 subjects each. All individuals taking part in the study will be recorded for clinical parameters i.e. Gingival index, Plaque index, Clinical attachment level, and Probing pocket depth along with standardized photographs of maxillary anterior sextant taken in triplicates (m1, m2, m3) by the same operator at baseline and 3 months followup. Individuals belonging to Group 1 and Group 2 will undergo routine SRP with hand and ultrasonic instruments at baseline 6 weeks and 12 weeks. The photographs will be taken with a Nikon L280 digital camera with a ring flash. The specifications will be kept at ISO 125, shutter speed 1/200, aperture F20, white balance, and 8% grey scale. The camera will be placed at a fixed distance from the patient’s oral cavity using a tripod. Chee retractors will be used for better visualization. A disc will be cut from a sheet of red articulating paper. The disc will have almost identical red pixel values when checked before use. It will be attached using the patient’s saliva to the upper left lateral incisors to facilitate standardization. Calibration and analysis of the images for quantification of gingival color will be done using color space converter software. A routine at the region of interest will be marked on the digital photograph. The image will be split into different images based on the coordinates present in CIELab and HSB color space respectively. In all the images that will be taken in triplicates (m1, m2, m3) three fixed points in the XY axis will be selected and the values will be recorded for all coordinates in both CIELab and HSB color space. |