| CTRI Number |
CTRI/2026/03/105707 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare a natural herbal medicine (chicory leaf extract) and chlorhexidine gel in improving gum health in patients with chronic gum disease |
|
Scientific Title of Study
|
A clinical, radiographical and microbiological study for evaluating and comparing natural chicory leaf extract with synthetic chlorhexidine in the management of stage 2 grade B chronic periodontitis as a local drug delivery agent: a split-mouth 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 Anamika Agrawal |
| Designation |
Post Graduate Student |
| Affiliation |
Goa Dental College And Hospital |
| Address |
Goa Dental College And Hospital, Department Number 2,
Department of Periodontics, Bambolim, Goa
North Goa
GOA
403202
India
North Goa
GOA
403202
India |
| Phone |
9359548117 |
| Fax |
|
| Email |
anamikaagrawal2409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr James Samuel |
| Designation |
Professor and Head Of Department (PG Guide) |
| Affiliation |
Goa Dental College And Hospital |
| Address |
Goa Dental College and Hospital, Department no 2, Department of
Periodontics, Bambolim, Goa
North Goa
GOA
403202
India
North Goa
GOA
403202
India |
| Phone |
9822151608 |
| Fax |
|
| Email |
jamessamueldental@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr James Samuel |
| Designation |
Professor and Head Of Department (PG Guide) |
| Affiliation |
Goa Dental College And Hospital |
| Address |
Goa Dental College and Hospital, Department no 2, Department of
Periodontics, Bambolim, Goa
North Goa
GOA
403202
India
North Goa
GOA
403202
India |
| Phone |
9822151608 |
| Fax |
|
| Email |
jamessamueldental@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Dental College And Hospital, Bambolim, Goa North Goa GOA 403202 INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Anamika Agrawal |
| Address |
Goa Dental College And Hospital, Department Number 2,
Department Of Periodontics, Bambolim, Goa 403202 |
| 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 Anamika |
Goa Dental College And Hospital |
Department Number 2,
Department of
Periodontics,
Bambolim, Goa
North Goa
GOA
North Goa
GOA |
9359548117
anamikaagrawal2409@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Dental College And Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy individuals with chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group (Group B): Chlorhexidine Local Drug Delivery |
Patients in this group will receive full mouth scaling and root planing (SRP) followed by local drug delivery using 1% chlorhexidine gel (Hexigel) after 15 days.
Method of Administration:
Absorbable gelatin sponge (Surgifoam) will be cut into appropriate sizes and impregnated with 1% chlorhexidine gel.
The chlorhexidine-loaded gelatin sponge will be placed into selected periodontal pockets with probing depths of 5–7 mm using sterile tweezers ensuring complete pocket fill.
The procedure will be performed under aseptic conditions following SRP.
Frequency of intervention: Single application per selected site
Total duration of intervention: One-time local drug delivery following SRP
No repeat application will be carried out during the study period.
Clinical Evaluation:
Periodontal parameters including:
• Probing Pocket Depth (PPD)
• Clinical Attachment Level (CAL)
• Gingival Index (GI)
• Plaque Index (PI)
will be assessed at baseline and at 1 month, 3 months, and 6 months post-treatment.
Microbiological Evaluation:
Subgingival plaque samples will be collected at baseline and at 6 months for microbial analysis.
Radiographic Evaluation:
Standardized intraoral periapical radiographs using long cone paralleling technique will be taken at baseline and at 6 months to evaluate alveolar bone level changes.
Follow-up and Outcome Assessment:
Clinical, microbiological, and radiographic evaluations will be carried out at baseline, 1 month, 3 months, and 6 months. |
| Intervention |
Test Group (Group A): Chicory Leaf Extract Local Drug Delivery |
Patients diagnosed with Stage 2 Grade B chronic periodontitis will undergo full mouth scaling and root planing (SRP). After a healing period of 15 days, two bilateral or contralateral periodontal sites with probing pocket depth (PPD) of 5–7 mm associated with horizontal bone loss will be selected.
Preparation of Chicory Leaf Extract:
Standardized chicory (Cichorium intybus) leaf extract will be prepared by mixing the measured quantity of chicory leaf extract in sterile distilled water to obtain a uniform solution suitable for local drug delivery. The solution will be freshly prepared under aseptic conditions prior to each application.
Method of Administration:
Absorbable gelatin sponge (Surgifoam) will be cut into site-specific sizes under sterile conditions and soaked in the prepared chicory leaf extract solution.
The saturated gelatin sponge will be gently inserted into the periodontal pocket using sterile tweezers or blunt cannula in an apico-coronal direction ensuring complete filling of the pocket.
The placement will be performed following SRP under aseptic conditions.
Frequency of intervention: Single application per selected site
Total duration of intervention: One-time local drug delivery following SRP
No repeat application of the local drug delivery agent will be performed during the study period. Patients will be instructed to avoid chewing hard foods at the treated site and to maintain proper oral hygiene.
Clinical Evaluation:
Periodontal parameters including:
• Probing Pocket Depth (PPD)
• Clinical Attachment Level (CAL)
• Gingival Index (GI)
• Plaque Index (PI)
will be recorded at baseline prior to intervention and reassessed at 1 month, 3 months, and 6 months post-treatment.
Microbiological Evaluation:
Subgingival plaque samples will be collected using sterile paper points at baseline and at 6 months for microbiological analysis.
Radiographic Evaluation:
Intraoral periapical radiographs using long cone paralleling technique will be taken at baseline and at 6 months to assess changes in alveolar bone levels.
Follow-up and Outcome Assessment:
Patients will be followed up and evaluated at 1 month, 3 months, and 6 months post-intervention. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals
Patients diagnosed with Stage 2 Grade B chronic periodontitis
Presence of localized bilateral or contralateral periodontal pockets with probing pocket depth (PPD) of 5–7 mm
Presence of horizontal alveolar bone loss associated with selected sites
Patients willing to participate and able to provide written informed consent |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in the study
Presence of any systemic disease or condition that may affect periodontal healing
History of antibiotic therapy within the past 6 months
Patients who have received periodontal treatment in the past 6 months
Patients with known allergy or hypersensitivity to chicory leaf extract or chlorhexidine gel
Smokers or tobacco users in any form
Pregnant or lactating women
Patients with poor oral hygiene compliance |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Probing Pocket Depth (PPD)
|
Baseline,1 month,3 months and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gain in Clinical Attachment Level (CAL) |
Baseline,1 month,3 months and 6 months
|
| Reduction in Gingival Index (GI) |
Baseline,1 month,3 months and 6 months
|
| Reduction in Plaque Index (PI) |
Baseline,1 month,3 months and 6 months
|
Reduction in subgingival microbial load
|
Baseline and 6 months |
| Radiographic improvement in alveolar bone levels |
Baseline and 6 months |
| Assessment of patient tolerance and adverse effects |
Throughout the study period |
|
|
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 4 |
|
Date of First Enrollment (India)
|
05/05/2026 |
| 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 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
|
This randomized split-mouth controlled clinical trial aims to evaluate and compare the clinical, radiographic, and microbiological efficacy of chicory (Cichorium intybus) leaf extract and 1% chlorhexidine gel as local drug delivery agents used as adjuncts to scaling and root planing in patients with Stage 2 Grade B chronic periodontitis. A total of 20–30 systemically healthy patients aged 30–65 years presenting with bilateral periodontal pockets of 5–7 mm associated with horizontal bone loss will be recruited. Following full mouth scaling and root planing, selected contralateral sites in each patient will receive either chicory leaf extract or chlorhexidine gel delivered subgingivally using an absorbable gelatin sponge. Clinical parameters including probing pocket depth, clinical attachment level, gingival index, and plaque index will be recorded at baseline and at 1, 3, and 6 months post-intervention. Microbiological assessment of subgingival plaque samples and standardized intraoral periapical radiographic evaluation of alveolar bone levels will be performed at baseline and at 6 months. The study aims to determine whether chicory leaf extract can serve as an effective and biocompatible alternative to chlorhexidine in the management of chronic periodontitis. |