| CTRI Number |
CTRI/2024/04/065477 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of Gingival inflammation and plaque accumulation by microneedling |
|
Scientific Title of Study
|
Effectiveness of Microneedling Technique
Using Olive Oil on The Severity of Gingival Inflammation and Plaque Accumulation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarna Meenakshi p |
| Designation |
Post Graduate Student |
| Affiliation |
saveetha dental college, chennai |
| Address |
Clinic 25, 4th floor, Department of Periodontics, Saveetha dental college, no-162, poonamalle high road, velappanchavadi, chennai-600077, Tamil Nadu.
7
Chennai
TAMIL NADU
600077
India |
| Phone |
09578983680 |
| Fax |
|
| Email |
swarnameenakshi1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subasree S |
| Designation |
Senior lecturer |
| Affiliation |
saveetha dental college, chennai |
| Address |
Clinic 25, 4th floor, Department of Periodontics, Saveetha dental college and hospital, no-162, poonamalle high road, velappanchavadi, chennai-600077, tamil nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9710632868 |
| Fax |
|
| Email |
subasrees.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Swarna Meenakshi p |
| Designation |
Post Graduate Student |
| Affiliation |
saveetha dental college, chennai |
| Address |
Clinic 25, 4th floor, Department of Periodontics, Saveetha dental college and hospital, no-162, poonamalle high road, velappanchavadi, chennai-600077, tamil nadu
TAMIL NADU
600077
India |
| Phone |
09578983680 |
| Fax |
|
| Email |
swarnameenakshi1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals, saveetha institute of medical and technical sciences, saveetha university,162,Poonamalle high road,
Velappanchavadi, Chennai-600077, Tamil Nadu
Chennai
TAMIL NADU
600077
India |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College SIMATS University Chennai |
| Address |
Clinic 25, 4th floor, Department of Periodontics, Saveetha dental college and hospital, no-162, poonamalle high road, velappanchavadi, chennai-600077, tamil nadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| swarna meenakshi |
Saveetha Dental college and hospital, SIMATS University, Chennai |
Clinic 25, 4th floor, Department of Periodontics, Saveetha dental college and hospital, no-162, poonamalle high road, velappanchavadi, chennai-600077, tamil nadu
Chennai
TAMIL NADU |
9578983680
swarnameenakshi1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gingival inflammation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microneedling and olive oil |
after mechanical subgingival scaling, microneedling is done with olive oil as an adjunct |
| Comparator Agent |
Subgingival Scaling |
subgingival scaling is done for periodontitis patients |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) patients aged between 20-50 years of age; 2) patients who were systemically healthy; 3) mild to moderate plaque induced gingivitis patients; 4) patients those who do not have gingival pigmentation. |
|
| ExclusionCriteria |
| Details |
1)individuals with periodontitis; 2) individuals who smoke or those who have tobacco related habits; 3) individuals who are partially edentulous; 4) Individuals who are diagnosed with drug induced gingival enlargement |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gingival index |
baseline, 1 week, 2 weeks, 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque index |
baseline, 1 week, 2 weeks, 1 month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background: Gingival inflammation, a hallmark of periodontal diseases, serves as a critical focus in oral health research. Characterized by redness, swelling, and bleeding of the gingival tissues, it reflects the body’s response to bacterial biofilms accumulating on the tooth surfaces. This inflammatory process, initiated by the interaction between oral bacteria and the host immune system, can lead to a spectrum of periodontal conditions ranging from mild gingivitis to severe periodontitis. Understanding the efficacy of various methods to treat gingival inflammation is essential for refining treatment strategies and enhancing patient satisfaction in the realm of gingival inflammation. Aim: The objective of the study was to evaluate the efficacy of employing the microneedling technique with olive oil on gingival inflammation and plaque accumulation in individuals with gingivitis. This involved the creation of microholes in the gingival tissue to enhance the concentration and penetration of the oils through the gingival tissues. Materials and Methods: Twenty-four individuals diagnosed with plaque-induced gingivitis were selected from Saveetha Dental College, Chennai. Participants will be randomly assigned to one of two groups: Group A, comprise of twelve individuals who receive periodontal mechanical treatment only and Group B, consisting of twelve individuals treated with dermapen and topical olive oil. Post-intervention assessments of gingival and plaque status will be conducted using a modified average gingival index and a plaque index at baseline, 1, 2, and 4 weeks. |