| CTRI Number |
CTRI/2023/12/060526 [Registered on: 19/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Placement of local drug delivery Liquorice gel in subgingival pockets in chronic periodontitis patients |
|
Scientific Title of Study
|
Evaluation of the efficacy of Liquorice gel as an adjunct to non-surgical periodontal therapy in chronic periodontitis:A randomized control, clinico-microbial 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 |
Vaishnavi Sanjay Shah |
| Designation |
Post-graduate student |
| Affiliation |
Yogita Dental College and Hospital , Khed |
| Address |
Yogita Dental College and Hospital , Khed, Ratnagiri, Department of Periodontology(24)
Ratnagiri MAHARASHTRA 415709 India |
| Phone |
9730120332 |
| Fax |
|
| Email |
drshahvaishnavi123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrPrashanth Shetty |
| Designation |
Professor |
| Affiliation |
Yogita Dental College and Hospital , Khed |
| Address |
Yogita Dental College and Hospital , Khed, Ratnagiri, Department of Periodontology(24)
Ratnagiri MAHARASHTRA 415709 India |
| Phone |
9886191999 |
| Fax |
|
| Email |
drprashanthshetty3@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrPrashanth Shetty |
| Designation |
Professor |
| Affiliation |
Yogita Dental College and Hospital , Khed |
| Address |
Yogita dental college and hospital , Khed , Ratnagiri, Department of Periodontology (24)
Ratnagiri MAHARASHTRA 415709 India |
| Phone |
9886191999 |
| Fax |
|
| Email |
drprashanthshetty3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yogita Dental College and Hospital , Khed , Ratnagiri, Department of Periodontology (24) |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Shah |
| Address |
yogita dental college and hospital, khed , ratnagiri |
| Type of Sponsor |
Research institution |
|
|
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 Vaishnavi Shah |
Yogita Dental College and Hospital |
Yogita Dental College and Hospital, Khed , Ratnagiri, Department of Periodontology (24)
Ratnagiri MAHARASHTRA |
9730120332
drshahvaishnavi123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YOGITA DENTAL COLLEGE INSTITUTIONAL ETHICAL COMMITTE |
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 |
| Intervention |
Liquorice gel |
The study spans for 3months in which the the intervention agent Liquorice gel application will be done only once after scaling and root planing in the whole study span. |
| Comparator Agent |
Scaling and root planing |
The study span for 3 months in which the standard protocol for periodontitis patients that is scaling and root planing will be done at baseline . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.A minimum of 20 natural teeth present
3.Healthy patients diagnosed with chronic periodontitis.
4. Patients having pocket probing depth of 4-6 mm.
|
|
| ExclusionCriteria |
| Details |
1.Tobacco-smokers, electronic cigarette users, smokeless tobacco product users, alcohol users.
2.Individuals that had used antibiotics, probiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 3-month.
3.Individuals with systemic diseases (such as cardiovascular diseases,diabetes,, renal disorders, hepatic disorders and/or acquired immune deficiency syndrome/HIV.)
4.Lactating and/or pregnant females.
5.Third molars and fractured teeth with embedded root remnants.
6.Completely edentulous individuals.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment loss, Probing Depth, Microbial count |
Baseline , 1 month , 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index , Sulcus Bleeding Index |
Baseline , 1 month , 3 month |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/01/2024 |
| Date of Study Completion (India) |
20/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Shah, V., Shetty, P., Shetty, D. et al. Effectiveness of liquorice gel as an adjunct to non-surgical periodontal therapy in chronic periodontitis: a randomized controlled, clinical and microbiological trial. Sci Rep 2026. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Dental plaque bacteria are the primary cause of periodontitis, leading to inflammation of periodontal supporting tissues. For non-surgical therapy, scaling and root planing (SRP) is still the best option. Liquorice, a herbal agent rich in bioactive metabolites such as glabridin, glycyrrhizin, licoricidin, licochalcone A, and licorisoflavan A, has shown potential benefits in oral health. However, limited in vivo evidence exists regarding its efficacy in periodontitis. Therefore, this study aimed to evaluate the effectiveness of liquorice gel as an adjunct to SRP in patients with periodontitis. A randomized controlled clinical trial (RCT) was conducted involving 32 adults with moderate pockets and chronic periodontitis, who were randomly allocated to the two groups. Group A (test group, SRP + Liquorice gel), and Group B (control group, SRP). All patients underwent a comprehensive scaling and root planing procedure, received oral hygiene instructions, and were recalled after 21 days (baseline). Patients with persistent pockets were included in the study. Clinical parameters like probing pocket depth (PPD), clinical attachment level (CAL), sulcus bleeding index (SBI), and plaque index (PI), along with microbiological indicators, were assessed at baseline, 1 month, and 3 months. Statistical analysis was performed using Friedman’s test followed by the Mann–Whitney U test for intergroup comparison. Both groups demonstrated significant clinical and microbiological improvements from baseline to 1 month and 3 months (p < 0.001). The test group receiving liquorice gel adjunctive to scaling and root planing demonstrated greater reductions in plaque index (PI) and sulcus bleeding index (SBI), along with comparatively greater suppression of Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis. Clinical attachment level (CAL) improvements were comparable between groups. Both groups also demonstrated significant reductions in probing pocket depth (PPD) over the study period; however, intergroup differences in PPD were not statistically significant at the evaluated follow up intervals. Adjunctive liquorice gel was associated with additional improvements in selected clinical and microbiological outcomes, particularly plaque accumulation, gingival bleeding, and selected periodontal pathogens, compared with SRP alone over the three-month follow-up period. |