| CTRI Number |
CTRI/2025/01/079449 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFICIENCY OF 3 TYPES INTERDENTAL FLOSS
|
|
Scientific Title of Study
|
Comparative Evaluation of Efficiency of Conventional Floss, Expandable Floss and Dental Tape in Removing Interproximal Plaque- A Clinical Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monica Antony |
| Designation |
Postgraduate |
| Affiliation |
Post graduate student at Yenepoya dental college |
| Address |
Yenepoya dental college, Department of Periodontology, room no. 7, Derlakatte, Karnataka
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
7530081766 |
| Fax |
|
| Email |
drmonicaantony98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shruthy Prathap |
| Designation |
Additional professor |
| Affiliation |
Additional professor at Yenepoya dental college |
| Address |
Yenepoya dental college, Department of Periodontology, room no. 7, Derlakatte, Karnataka
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
9980433489 |
| Fax |
|
| Email |
shruthyprathap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monica Antony |
| Designation |
Postgraduate |
| Affiliation |
Post graduate student at Yenepoya dental college |
| Address |
Yenepoya dental college, Department of Periodontology, room no. 7, Derlakatte, Karnataka
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
7530081766 |
| Fax |
|
| Email |
drmonicaantony98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded. Conducted at Yenepoya Dental College, Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
Monica Antony |
| Address |
Gardyenia ladies hostel, Yenepoya dental college, Ashraya Colony, Ullal, Karnataka 575022 |
| 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 Monica |
Yenepoya dental college |
Department of Periodontology, room no. 7, Derlakatte, Karnataka
Dakshina Kannada
KARNATAKA |
7530081766
Drmonicaantony98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 |
For each participant, plaque index (PI), gingival index (GI), Papillary bleeding index (PBI) and
Rustogi modified Navy Plaque Index (RMNPI) will be recorded for all teeth.
Plaque index will be taken for the subjects who are willing to participate in the study. Subjects
with a PI score of 0.1 – 1.9 will undergo a washout period of 15 days. Colgate toothpaste and
Colgate medium toothbrush will be given to the subjects to use in this period along with
reinforcement of the modified bass brushing technique.
The patient will be reevaluated after 5 days, and plaque index will be taken. If the subjects have
a PI score of 0.1-0.9, they will be randomised into three groups.
Group 1: will include 16 subjects and will be instructed to use conventional floss. |
| Comparator Agent |
Group 2 |
Group 2: will include 16 subjects and will be instructed to use expnadable floss.
Recall appointments will be scheduled at 2nd ,4th ,6th and 8th week for re-evaluation. At the recall
appointments, clinical parameter recordings will be repeated by examiner for all the participants
followed by reinforcement of oral hygiene instructions. |
| Comparator Agent |
Group 3 |
Group 3: will include 16 subjects and will be instructed to use dental tape.
Recall appointments will be scheduled at 2nd ,4th ,6th and 8th week for re-evaluation. At the recall
appointments, clinical parameter recordings will be repeated by examiner for all the participants
followed by reinforcement of oral hygiene instructions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects between the age group 18-55 years
2. Moderate to severe gingivitis
3. Type I embrasures
4. Subjects with plaque scores between 0.1-0.9
5. Minimum 15 teeth present
6. Systemically healthy patients |
|
| ExclusionCriteria |
| Details |
1. Subjects with periodontal disease.
2. Grossly decayed teeth, proximal caries
3. Teeth with fracture, erosion, crack
4. Undergoing orthodontic treatment
5. Subjects using tobacco
6. Teeth with crowns and proximal restorations
7. patients with dental implants
8. patients with developmental and hand dexterity problems |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the efficiency of conventional floss, expandable floss and dental tape in reduction of interproximal plaque scores and gingival inflammation |
2,4,6,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the anti-shred property and tensile load capacity of conventional floss,
expandable floss and dental tape |
2,4,6,8 weeks |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is generally accepted that bacterial plaque is an important etiological factor of periodontal diseases. Despite recent advances in dentistry, mechanical removal of plaque remains the primary method. But the use of toothbrush alone does not serve the purpose of removing plaque which demands the use of some adjuncts such as proximal cleaning aids. Some of the proximal aids include dental floss, interdental brush, toothpicks, dental tape etc. A total of 48 subjects were divided into 3 groups, 16 in each group and the flosses were distributed randomly among the groups to determine the plaque removal efficiency of each. The patients were recalled at week 2,4,6, and 8. At each visit, the following indices were assessed: gingival index, papillary bleeding index and Rustogi modified Navy Plaque index. The load bearing capacity of the floss was tested with the universal testing machine and the anti-shred property of the flosses were checked using the stereo microscope. There are fewer studies comparing the effectiveness and anti- shred property of conventional floss, expandable floss and dental tape. Not much information is present regarding dental tape probably due to the assumed similarity between conventional floss and dental tape. This study aims to compare the interproximal plaque removal efficiency between conventional floss, expandable floss and dental tape. |