| CTRI Number |
CTRI/2022/06/043334 [Registered on: 17/06/2022] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
current study is designed as to evaluate and compare the efficacy of Herbal gel with non-surgical periodontal therapy and non-surgical periodontal therapy alone in stage III periodontititis |
|
Scientific Title of Study
|
Comparative evaluation of Herbal Gel as an adjunct to non-surgical periodontal therapy in stage III periodontitis: Clinico-radiographic study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surekha Rathod |
| Designation |
Professor |
| Affiliation |
VSPM Dental college and Research Centre |
| Address |
104, Department of periodontics and Implant Dentistry, VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Rathod |
| Designation |
Professor |
| Affiliation |
VSPM Dental college and Research Centre |
| Address |
104 Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surekha Rathod |
| Designation |
Professor |
| Affiliation |
VSPM Dental college and Research Centre |
| Address |
103, Department of periodontics and implantology VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104 Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur 440019
|
|
|
Primary Sponsor
|
| Name |
Nill |
| Address |
Nill |
| Type of Sponsor |
Other [None] |
|
|
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 Surekha Rathod |
VSPM Dental College and Research Center, Nagpur |
104 Department of Periodontics and Implantology
Nagpur
MAHARASHTRA |
9011071477
drsurekhar@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 |
| Healthy Human Volunteers |
Chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
scaling and root planning |
Stage III periodontitis to be treated with non-surgical periodontal therapy (NSPT). |
| Intervention |
scaling and root planning and herbal gel |
Stage III periodontitis to be treated with non-Surgical Periodontal Therapy (NSPT) followed by Herbal gel placement subgingivally. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with stage III periodontitis as assessed by PPD ≥ 5mm and CAL> 6mm.
2) Patients with at least one pair of IBDs in either maxillary or mandibular arch.
|
|
| ExclusionCriteria |
| Details |
1) Patients with history of systemic diseases, allergies or drug usage.
2) Individual had a prior use of non-steroidal anti-inflammatory drugs or antimicrobial drugs in the last 3 months.
3) Pregnant or lactating women.
4) Patient who has undergone periodontal treatment in last 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Attachment Level (CAL)
Bone Fill
|
Baseline, 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PPD (Probing Pocket Depth)
PI (Plaque Index)
GI (Gingival Index)
mSBI (Modified sulcular Bleeding Index)
|
Baseline, 3months, 6months |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/07/2022 |
| Date of Study Completion (India) |
21/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/06/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted to evaluate and compare the effects of Herbal gel in combination with non- surgical periodontal treatment and non-surgical periodontal treatment alone in a treatment of stage III periodontitis patients, clinically and radiographically by RVG. A total of 22 subjects including both male and female visiting the Department of Periodontics and implantology at VSPM Dental College and research centre Nagpur will be recruited. Study will be divided into 2 groups Group I – Stage III periodontitis to be treated with non-surgical periodontal therapy (NSPT). Group II – Stage III periodontitis to be treated with non-Surgical Periodontal Therapy (NSPT) followed by Herbal gel placement subgingivally. Prior to initiating the study, its purpose and design will be explained and informed consent will be signed by every patient. Probing pocket depth and clinical attachment level will be measured using UNC #15 probe and custom-made acrylic stent made to compare the measurement at each recall visit. Clinical procedure will consist of Non-Surgical Periodontal Therapy in both groups. Group I patients will be treated by Non-Surgical Periodontal Therapy only. Group II patients will be treated by Non-Surgical Periodontal Therapy and Herbal gel subgingivally, then periodontal pack is given. Patients will be instructed to refrain from chewing hard or sticky foods, brushing near the treated areas, or using any interdental aids for 1 week. Patients will be recalled at 3 months and 6 months postoperatively. |