| CTRI Number |
CTRI/2025/10/096016 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Homeopathy
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Healing gum inflammation using microneedling, light therapy, and Calendula: A Clinical Study |
|
Scientific Title of Study
|
Exploring the role of Microneedling and Photo biomodulation with calendula officinalis in gingivitis treatment: A randomized clinical split mouth 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 |
Punugunta Jahnavi |
| Designation |
Post graduate student |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Department of Periodontics,Lenora institute of dental sciences,Rajanagaram,Rajahmundry,Andhra Pradesh,India
Department of Periodontics,Lenora institute of dental sciences,Rajanagaram,Rajahmundry,Andhra Pradesh,India
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
6305292209 |
| Fax |
|
| Email |
jahnavipunugunta97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Punugunta Jahnavi |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Department of Periodontics,Lenora institute of dental sciences,Rajanagaram,Rajahmundry,Andhra Pradesh,India
Department of Periodontics,Lenora institute of dental sciences,Rajanagaram,Rajahmundry,Andhra Pradesh,India
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
6305292209 |
| Fax |
|
| Email |
jahnavipunugunta97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nandipati Sowmya Reddy |
| Designation |
Assistant Professor |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Department of Periodontics,Lenora institute of dental sciences,Rajanagaram,Rajahmundry,Andhra Pradesh,India
Department of Periodontics,Lenora institute of dental sciences,Rajanagaram,Rajahmundry,Andhra Pradesh,India
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
6381512793 |
| Fax |
|
| Email |
sowmyareddy848@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lenora institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
Jahnavi |
| Address |
Department of Periodontics,Lenora institute of dental sciences,Rajanagaram,Rajahmundry,Andhra Pradesh,India,533294 |
| 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 |
| DrPunugunta Jahnavi |
Lenora Institute Of Dental Sciences |
Room Number-5,Second floor,Department Of Periodontics
East Godavari
ANDHRA PRADESH |
6305292209
jahnavipunugunta97@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: K061||Gingival enlargement, (2) ICD-10 Condition: K061||Gingival enlargement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Microneedlng with calendula officinalis |
No.5,Second floor, Department of Periodontics, Lenora institute of dental sciences, Rajanagaram |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with generalised plaque induced gingival inflammation |
|
| ExclusionCriteria |
| Details |
Patients with a history of periodontal therapy in the past 6 months, systemic diseases, or those on medications affecting periodontal health were excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bleeding index,Plaque index,Gingival index are measured |
All three indices were measured at baseline,1 week,1 month,3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
24/10/2025 |
| 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="0"
Months="3"
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
|
This randomized clinical split-mouth study evaluated the efficacy of microneedling with Calendula officinalis and adjunctive photobiomodulation in gingivitis management. Ten patients with generalized gingival inflammation were included. In the test group, microneedling was followed by topical Calendula and low-level laser therapy, while the control group received microneedling with Calendula alone. Clinical parameters—Plaque Index, Gingival Index, and Gingival Bleeding Index—were recorded at baseline, 7 days,one month and three months. Findings suggest that combining microneedling, herbal therapy, and laser-based photobiomodulation may accelerate healing, reduce inflammation, and provide a minimally invasive adjunct to conventional periodontal care. |