| CTRI Number |
CTRI/2026/02/102906 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two doxycycline gels used along with cleaning of teeth and gums in people with severe gum disease |
|
Scientific Title of Study
|
Comparative evaluation of a Novel Doxycycline gel and 10 percent Doxycycline Hyclate Gel as an adjunct to Scaling and Root Planing in Stage III Periodontitis A Randomized Controlled 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 Vrushali Lathiya |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09561100520 |
| Fax |
|
| Email |
drvrushalilathiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrushali Lathiya |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09561100520 |
| Fax |
|
| Email |
drvrushalilathiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrushali Lathiya |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09561100520 |
| Fax |
|
| Email |
drvrushalilathiya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
none |
| Address |
Ranjeet Deshmukh Dental College and Research Centre Nagpur |
| 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 Vrushali Lathiya |
104 Department of Periodontology and Implant Dentistry |
Ranjeet Deshmukh Dental College and Research Centre Hingna Nagpur
Nagpur
MAHARASHTRA |
09561100520
drvrushalilathiya@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 |
| Comparator Agent |
10 percent doxycycline hyclate gel |
this is a commercially available gel used to create antimicrobial enviornment in the periodontal pockets will be adiministered using a syringe locally once at baseline |
| Intervention |
Novel doxycycline gel |
novel doycycline gel is formulated using proniosomes as delivery vescicles which improves substantivity compared to commercially available will be adiministered using a syringe locally once at baseline |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients with stage two and three Periodontitis.
Non-smokers.
Presence of more than one site with probing pocket depth four to six mm.
No periodontal treatment in the past six months.
|
|
| ExclusionCriteria |
| Details |
Systemic diseases
Pregnancy or lactation
Antimicrobial therapy less than three months.
History of allergy and alcohol or drug abuse and smoking |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PPD and RAL |
1 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GI PI and patient comfort |
1 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="6"
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
|
The study will compare the efficacy of a novel doxycycline gel with a commercially available doxycycline gel in stage two and three periodontitis |