| CTRI Number |
CTRI/2025/08/093324 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of curcumin gel and diode laser in non surgical treatment of Patients with gum problems. |
|
Scientific Title of Study
|
Curcumin gel and diode laser application as an adjunct to scaling and root planing in periodontist patients-A Clinical comparatively 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 |
DrThinley lhamu onge |
| Designation |
post graduate |
| Affiliation |
maharishi markandeshwar college of dental sciences and research |
| Address |
department of periodontology, room number 7, MMCDSR, Mullana Ambala Haryana
Ambala
HARYANA
133207
India |
| Phone |
8527659441 |
| Fax |
|
| Email |
drthinleyonge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kocher |
| Designation |
Professor |
| Affiliation |
maharishi markandeshwar college of dental sciences and research |
| Address |
department of periodontology, room number 7, MMCDSR, Mullana Ambala Haryana
Ambala
HARYANA
133207
India |
| Phone |
9991099901 |
| Fax |
|
| Email |
drdeepakkocher77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kocher |
| Designation |
Professor |
| Affiliation |
maharishi markandeshwar college of dental sciences and research |
| Address |
department of periodontology, room number 7, MMCDSR, Mullana Ambala Haryana
Ambala
HARYANA
133207
India |
| Phone |
9991099901 |
| Fax |
|
| Email |
drdeepakkocher77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar University ( Deemed to be University ) Mullana Haryana India 133203 |
|
|
Primary Sponsor
|
| Name |
Dr Thinley lhamu onge |
| Address |
department of periodontology, room number 7 MMCDSR Mullana Ambala Haryana
133203 |
| 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 |
| Dr Thinley Lhamu Onge |
Maharishi Markandeshwar college of dental sciences and research |
department of periodontology, room number 7 Mullana Ambala Haryana
Ambala
HARYANA |
8527659441
drthinleyonge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Maharishi Markandeshwar( Deemed to be ) University |
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 |
| Comparator Agent |
SRP group |
Scaling and root planning |
| Intervention |
SRP with Laser group |
Scaling and Root planning with Laser |
| Intervention |
SRP with Local Drug delivery group |
Scaling and Root Planning with Local drug delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Age between eighteen to fifty five years
2 Gender Both males and females will be part of the study
3 Co-operative and motivated patients committed to oral hygiene
4 Periodontitis patients with pockets and loss of attachment on at least three sites one per quadrant with radiographic evidence of bone loss |
|
| ExclusionCriteria |
| Details |
1 Patients with poor oral hygiene
2 smokers alcoholics and patients with other adverse habits
3 acute or chronic systemic diseases that could influence the outcome of periodontal therapy
4 patients on any long term systemic therapy
5 history of periodontal treatment in the past six months
6 pregnant and lactating women
7 any known allergy or hypersensitivity to any product used in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effectiveness of Curcumin gel ( Curenext gel) and Laser as an adjunct to SRP in the treatment of periodontitis |
Baseline , 6 weeks , 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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="1"
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
|
|
Brief Summary
|
The purpose of the study is to evaluate the effectiveness of Curcumin gel (Curenext gel) and laser as an adjunct to SRP for the treatment of periodontitis . The Null hypothesis is that there is no significant difference between the treatment modalities. |