| CTRI Number |
CTRI/2024/08/072209 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the changes in the chewing efficiency of individuals having gum diseases after treatment. |
|
Scientific Title of Study
|
Evaluation of the Alterations in Masticatory Efficiency in Individuals with Periodontitis after Regenerative Periodontal Therapy- An Experimental 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 |
Dr Nikita Patil |
| Designation |
Senior Lecturer |
| Affiliation |
D Y Patil Deemed to be University School of Dentistry |
| Address |
Department of Periodontics, DY Patil Deemed to be University School of Dentistry, Sector 7, DY Patil Vidyanagari, Highway road, Nerul, Navi Mumbai
Department of Periodontics, DY Patil Deemed to be University School of Dentistry, Sector 7, DY Patil Vidyanagari, Highway road, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9699696160 |
| Fax |
|
| Email |
drpatilnikita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Gaikwad |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital |
| Address |
Department of Periodontics, 2nd floor, Government Dental college and Hospital, Fort, Mumbai
Department of Periodontics, 2nd floor, Government Dental college and Hospital, Fort, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400001
India |
| Phone |
9821098772 |
| Fax |
|
| Email |
perioraja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Patil |
| Designation |
Sr. Lecturer |
| Affiliation |
D Y Patil Deemed to be University School of Dentistry |
| Address |
Department of Periodontics, DY Patil Deemed to be University School of Dentistry, Nerul, Navi Mumbai
Department of Periodontics, DY Patil Deemed to be University School of Dentistry, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9699696160 |
| Fax |
|
| Email |
drpatilnikita@gmail.com |
|
|
Source of Monetary or Material Support
|
| DY Patil Deemed to be University School of Dentistry, Department of Periodontics, 5th floor, Sector 7, Highway Road, Dr D Y Patil Vidyanagar, Nerul, Navi Mumbai, Maharashtra 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Patil |
| Address |
DY Patil Deemed to be University School of Dentistry, Department of Periodontics, 5th floor, Sector 7, Highway Road, Dr D Y Patil Vidyanagar, Nerul, Navi Mumbai, Maharashtra 400706 |
| 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 Nikita Patil |
Government Dental College and Hospital, Mumbai |
208, second floor, Government Dental College and Hospital, Fort, Mumbai
Mumbai
MAHARASHTRA |
8369743101
dr.patilnikita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
1 DFDBA bone graft and collagen membranes
2 patients will be asked to chew on dual colored chewing gums 20 times . |
Regenerative procedure (DFDBA bone graft and collagen membranes) will be done once.
2 Patients will be asked to chew on dual colored chewing gums 20 times- This will be repeated 4 times during each follow up. Patients will be followed up at 0,3,6 and 9 months. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age range of 25-50 years
2. Patients with chronic periodontitis 2-3 walled intrabony defects
3. Minimum 12 occlusal units
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients
2. Patients with more than one unit fixed prosthesis/dental implants
3. Patients with a previous history of periodontal therapy/ antibiotic therapy in the last 3 months
4. Pregnant/ Lactating females
• Patients with a history of smoking/present smokers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth
Clinical attachment level
residual bone height
masticatory alterations |
0,1,3,6,9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PPD, CAL, Residual bone height |
0,1,3,6,9 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/12/2024 |
| 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="3"
Months="3"
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
|
based on the hypothesis that alterations may occur in the process of chewing due to reduced alveolar bone support and due to the scarcity of studies in the literature on the effects of periodontal regeneration and its effects on mastication, the present study aims to evaluate the effect of regenerative periodontal therapy on masticatory cycle efficiency in patients with periodontitis |