| CTRI Number |
CTRI/2025/01/079678 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of different types of Post-Treatment Communication on Oral Hygiene Performance and Gingival Status in Gingivitis Patients: A Randomized Control Trial
|
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Scientific Title of Study
|
Effects of three different types of Post-Treatment Communication on Oral Hygiene Performance and Gingival Status in Gingivitis Patients: A Randomized Control Trial |
| 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 Martoni Dutta |
| Designation |
MDS Student |
| Affiliation |
YENEPOYA DENTAL COLLEGE |
| Address |
ROOM NO. 7, DEPARTMENT OF PERIODONTOLOGY, YENEPOYA DENTAL COLLEGE
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
ROOM NO. 7, DEPARTMENT OF PERIODONTOLOGY, YENEPOYA DENTAL COLLEGE
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575017
India |
| Phone |
07872943910 |
| Fax |
|
| Email |
rahidutta6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinita Boloor |
| Designation |
Additional Professor |
| Affiliation |
YENEPOYA DENTAL COLLEGE |
| Address |
ROOM NO. 7, DEPARTMENT OF PERIODONTOLOGY, YENEPOYA DENTAL COLLEGE
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
ROOM NO. 7, DEPARTMENT OF PERIODONTOLOGY, YENEPOYA DENTAL COLLEGE
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845114652 |
| Fax |
|
| Email |
drvinitaboloor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Martoni Dutta |
| Designation |
MDS Student |
| Affiliation |
YENEPOYA DENTAL COLLEGE |
| Address |
ROOM NO. 7, DEPARTMENT OF PERIODONTOLOGY, YENEPOYA DENTAL COLLEGE
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
ROOM NO. 7, DEPARTMENT OF PERIODONTOLOGY, YENEPOYA DENTAL COLLEGE
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575017
India |
| Phone |
07872943910 |
| Fax |
|
| Email |
rahidutta6@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROOM NO. 7, DEPARTMENT OF PERIODONTOLOGY, YENEPOYA DENTAL COLLEGE
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
Dr Martoni Dutta |
| Address |
ROOM NO. 7, DEPARTMENT OF PERIODONTOLOGY, YENEPOYA DENTAL COLLEGE
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018 |
| Type of Sponsor |
Other [Primary Researcher Sponsored] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MARTONI DUTTA |
YENEPOYA DENTAL COLLEGE |
ROOM NO. 7, DEPARTMENT OF PERIODONTOLOGY, YENEPOYA DENTAL COLLEGE
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA |
07872943910
rahidutta6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-1 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional scaling |
Scaling will be performed as a part of regular dental care. The participants in this group will not receive any sort of telephonic call or text message reminders for maintaining oral health and recall visits.
The recall visits will be on day14, day30 and day60. |
| Intervention |
TELEPHONIC CALL REMINDERS |
Call Content: Consistent structure for each call with introduction, assessment, addressing concerns, reinforcement, and conclusion.
Frequency of Calls: Twice a week (Sunday and Wednesday)
The telephonic call intervention will be performed for 60 days. Patients will be recalled on Day14, Day30 and Day60.
|
| Intervention |
TEXT MESSAGE REMINDERS |
TEXT CONTENT : Consistent structure for each TEXT with introduction, assessment, addressing concerns, reinforcement, and conclusion.
Frequency of Calls: Twice a week (Sunday and Wednesday)
The text message intervention will be performed for 60 days. Patients will be recalled on Day14, Day30 and Day60.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18-50 years
Subjects with Moderate to Severe gingivitis (Gingival Index, Loe and Silness 1963)
Systemically healthy subjects
Willingness to comply with the study protocol.
Access to a personal smartphone.
|
|
| ExclusionCriteria |
| Details |
Subjects with Periodontitis.
Previous history of periodontal therapy within 6 months.
Subjects who have received antibiotic and anti-inflammatory therapy in the last 3 months.
Pregnant or lactating women.
History of tobacco chewing or smoking.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Scaling and oral hygiene instructions on subjects’ oral hygiene performance and gingival status.
To evaluate the effect of Scaling and oral hygiene instructions along with text message reminders on subjects’ oral hygiene performance and gingival status.
To evaluate the effect of Scaling and oral hygiene instructions along with telephonic call reminders on subjects’ oral hygiene performance and gingival status.
|
Clinical parameters will be recorded at baseline and after 14 days, 30 days and 60 days
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
GINGIVAL INDEX (LOE AND SILNESS 1963)
SIMPLIFIED ORAL HYGIENE INDEX (GREENE AND VERMILLION 1964)
TURESKY MODIFICATION OF THE QUIGLEY–HEIN INDEX (TQHI)
(TURESKY S AND GILMORE 1970)
To compare the effect of Scaling & oral hygiene instructions along with text message reminders or telephonic call reminders on subjects’ oral hygiene performance & gingival status
To evaluate the sustained effect of post treatment communication on subjects’ oral hygiene performance & gingival status.
|
Day 0
Day 14
Day 30
Day 60 |
|
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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
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/02/2025 |
| 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="2"
Months="0"
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
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Brief Summary
|
Oral health is defined as being free from various chronic conditions and diseases affecting the oral cavity, with optimal oral hygiene being crucial for preventing issues such as dental caries and gingivitis. Gingivitis, caused by plaque accumulation, highlights the need for effective plaque control. Compliance with dental recommendations, which includes maintaining oral hygiene and regular dental visits, is vital for treatment success. Studies have shown that active reminders, such as telephone calls and text messages, can positively influence behavior, reduce appointment no-show rates, and improve adherence to treatment protocols. Effective post-procedure communication enhances patient satisfaction and strengthens the dentist-patient relationship. This study aims to determine which communication method—telephone or text—best promotes sustained patient compliance and provides a comprehensive understanding of their effects.
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