| CTRI Number |
CTRI/2025/02/080462 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Chlorhexidine Gel and a Gel with Both Chlorhexidine and Metronidazole for Treating Long-lasting Gum Disease. |
|
Scientific Title of Study
|
Comparative Evaluation of Chlorhexidine Gel alone and a Combination Gel Chlorhexidine and Metronidazole in treatment of Chronic Periodontitis |
| 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 Saheli Paul |
| Designation |
Post Graduate Student |
| Affiliation |
Army College of Dental Sciences |
| Address |
Room No. 10, PG clinic, Department of Periodontics, Army College of Dental Sciences Jai Jawahar nagar Chennapur CRPF road Secunderabad 500087
Hyderabad
TELANGANA
500087
India |
| Phone |
7701970916 |
| Fax |
|
| Email |
sahelipaul0512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Ajay Reddy |
| Designation |
Reader |
| Affiliation |
Army College of Dental Sciences |
| Address |
Room No. 10, Department of Periodontics, Army College of Dental Sciences Jai Jawahar nagar Chennapur CRPF road Secunderabad 500087
Hyderabad
TELANGANA
500087
India |
| Phone |
9618321234 |
| Fax |
|
| Email |
reddyajay56@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saheli Paul |
| Designation |
Post Graduate Student |
| Affiliation |
Army College of Dental Sciences |
| Address |
Room No. 10, PG clinic, Department of Periodontics, Army College of Dental Sciences Jai Jawahar nagar Chennapur CRPF road Secunderabad 500087
Hyderabad
TELANGANA
500087
India |
| Phone |
7701970916 |
| Fax |
|
| Email |
sahelipaul0512@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo medical store,
Army College of Dental Sciences Jai Jawahar nagar Chennapur CRPF road Secunderabad, Telangana, India-500087 |
| ICPA
Army College of Dental Sciences Jai Jawahar nagar Chennapur CRPF road Secunderabad, Telangana, India 500087 |
|
|
Primary Sponsor
|
| Name |
Dr Saheli Paul |
| Address |
Room No. 10, PG clinic, Department of Periodontics, Army College of Dental Sciences Jai Jawahar nagar Chennapur CRPF road Secunderabad, Telangana-500087 |
| 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 Saheli Paul |
Army College of Dental Sciences |
Room No. 10, PG clinic, Department of Periodontics, Army College of Dental Sciences Jai Jawahar nagar Chennapur CRPF road Secunderabad-500087
Hyderabad
TELANGANA |
7701970916
sahelipaul0512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The ACDS Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Periodontics |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine gel |
Scaling and root planing + local drug delivery (Chlorhexidine gel). dosage is once, Local application of gel for one day and will be followed up for one month. |
| Intervention |
Combination gel (Chlorhexidine + metronidazole). |
Scaling and root planing + local drug delivery (Chlorhexidine + metronidazole gel). dosage is once, Local application of gel for one day and will be followed up for one month. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of chronic periodontitis having bilateral periodontal pocket of probing depth 4mm-5mm.
Both sexes are included.
An age group of 20-50 years will be taken. |
|
| ExclusionCriteria |
| Details |
Patients who have already received periodontal therapy in past 1 year.
Pregnant women & lactating mothers.
Women using hormonal contraceptives or on hormonal replacement therapy.
Patients having habit of smoking or chewing tobacco.
Patients allergic to either Chlorhexidine or Metronidazole.
Patients having any known systemic conditions:- Diabetes, Hypertension, Thyroid disorders, or any
other condition affecting periodontal status. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recording reduction of Relative attachment level using Stent. |
0-30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival Index, Plaque Index, Pocket probing depth. |
0-30 Days |
|
|
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)
|
18/03/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sahelipaul0512@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Informed consent is obtained from participating subjects. The subjects are assessed for Gingival Index, Plaque Index, Relative attachment level, Pocket probing depth. Following the recordings of clinical parameters, scaling and root planing will be performed. The selected sites will be randomly allocated into Group I & Group II. The clinical parameters will be recorded at the baseline for both the groups i.e Group I and Group II before the commencement of the treatment. Group I - Scaling and root planing will be done followed by local drug delivery i.e., placement of Chlorhexidine gel. Group II - Scaling and root planing will be done followed by local drug delivery i.e., placement of gel containing combination of Chlorhexidine and Metronidazole. The clinical parameters will be recorded again after 30 days. |