| CTRI Number |
CTRI/2024/01/061465 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
12/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of quality of life in patients with gum disease after tooth instrumentation by different methods. |
|
Scientific Title of Study
|
Oral health related quality of life among patients receiving non-surgical periodontal therapy by hand and ultrasonic instruments delivered by different modes: a randomized clinical 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. Tony Kurien. J |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College, Kottayam |
| Address |
Department of Periodontics,
Government Dental College,
Kottayam District,
Kerala State.
Government Dental College,
Kottayam District,
Kerala State.
Kottayam
KERALA
686008
India |
| Phone |
9496160560 |
| Fax |
|
| Email |
tonykurienj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tony Kurien. J |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College, Kottayam. |
| Address |
Department of Periodontics,
Government Dental College,
Kottayam District,
Kerala State.
Government Dental College,
Kottayam District,
Kerala State.
Kottayam
KERALA
686008
India |
| Phone |
9496160560 |
| Fax |
|
| Email |
tonykurienj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Tony Kurien. J |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College, Kottayam. |
| Address |
Department of Periodontics,
Government Dental College,
Kottayam District,
Kerala State.
Government Dental College,
Kottayam District,
Kerala State.
Kottayam
KERALA
686008
India |
| Phone |
9496160560 |
| Fax |
|
| Email |
tonykurienj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics, Government Dental College,
Kottayam District,
Kerala State 686008 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Tony Kurien J |
Government Dental College, Kottayam, Kerala State. |
Department of Periodontics (Room No.801),
Government Dental College,
Kottayam District,
Kerala.
Kottayam
KERALA |
9496160560
tonykurienj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Dental College, Kottayam, Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Full mouth combination instrumentation. |
Scaling using Gracey curettes and piezo scalers by full mouth single appointment of 45 minutes to one hour duration. |
| Intervention |
Full mouth Gracey curette instrumentation |
Scaling using Gracey curettes by full mouth single appointment of 45 minutes to one hour duration. |
| Intervention |
Full mouth piezo scaler instrumentation. |
Scaling using piezo scalers by full mouth single appointment of 45 minutes to one hour duration. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Quadrant-wise Gracey curette instrumentation. |
Scaling using Gracey curettes by quadrant-wise multiple appointments of 30 minutes duration of each sitting. |
| Intervention |
Quadrant-wise piezo scaler instrumentation. |
Scaling using piezo scalers by quadrant-wise multiple appointments of 30 minutes duration of each sitting. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients diagnosed with stage II and III periodontitis based on 2017 world workshop on the classification of periodontal and peri-implant diseases and conditions.
2) Presence of more than or equal to sixteen permanent teeth in the mouth with at least one permanene molar an one incisor teeth in each quadrant.
3) Subjects with good general health.
4) No periodontal treatment done in the last six months. |
|
| ExclusionCriteria |
| Details |
1) Antibiotics or analgesics usage three months before or its need during the study period.
2) Pregnant and lactating mothers.
3) Presence of acute periodontal infections.
4) Usage of any medications affecting neural or motor systems.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in Oral Impact on Daily Performance (OIDP) score between baseline (T1) and third month (T2). |
Three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in Periodontal Inflamed Surface Area (PISA) value between baseline (T1) & third month (T2). |
Three months |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
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)
|
30/01/2024 |
| 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="9"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Data will be available for 1 year through e-mail ID tonykurienj@gmail.com with signed data access agreement.
- For how long will this data be available start date provided 15-01-2024 and end date provided 01-06-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized clinical trial to assess the oral health related quality of life in patients undergoing non-surgical periodontal therapy by hand and ultrasonic scaler instruments which will be delivered by different modes, being carried out at Department of Periodontics, Government Dental College, Kottayam, Kerala. The selected study subjects who will give their willingness to participate, will be randomly assigned to any one of the five groups by sequentially numbered sealed opaque envelopes. Periodontal charting will be done before the initiation of treatment along with their response to a questionnaire consisting of eight items to rate the impact of their oral health on their quality of life. The participants will be re-examined after 3 months and the same data will be recorded. Quantitative variables will be summarized into mean and standard deviation and significance of difference between the groups will be tested using one way ANOVA test. Intra-group difference at pre-treatment and post-treatment for oral health related quality of life will be compared using paired t-test. |