| CTRI Number |
CTRI/2025/01/079670 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Evaluation Of Peri-Implant Healing In Patients Using 0.12% Chlorhexidine And 0.12% Chlorhexidine Plus Hyaluronic Acid Mouthwash By Clinical And Immunological Analysis - An In Vivo Study |
|
Scientific Title of Study
|
A Comparative Evaluation Of Peri-Implant Healing In Patients Using 0.12% Chlorhexidine And 0.12% Chlorhexidine Plus Hyaluronic Acid Mouthwash By Clinical And Immunological Analysis - An In Vivo Study |
| 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 Shashank Agrawal |
| Designation |
MDS 2nd year student |
| Affiliation |
Government Dental College |
| Address |
Room no 12 Department of Periodontics Government Dental College Raipur chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
7898867987 |
| Fax |
|
| Email |
shashanka202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Gupta |
| Designation |
Prof and Head of Department |
| Affiliation |
Government Dental College |
| Address |
Room no 12 Department of Periodontics Government Dental College Raipur chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9131144870 |
| Fax |
|
| Email |
vinleo76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vineeta Gupta |
| Designation |
Prof and Head of Department |
| Affiliation |
Government Dental College |
| Address |
Room no 12 Department of Periodontics Government Dental College Raipur chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9131144870 |
| Fax |
|
| Email |
vinleo76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Raipur Chhattisgarh India 492001 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 SHASHANK AGRAWAL |
Government Dental College |
Room no 12 Department of Periodontics Government Dental College Raipur chhattisgarh
Raipur
CHHATTISGARH |
07898867987
shashanka202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics committee Government Dental College Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K062||Gingival and edentulous alveolar ridge lesions associated with trauma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.12% chlorhexidine Mouthwash |
Chlorhexidine is a gold standard antiseptic agent widely used in dentistry due to its proven efficacy against a broad spectrum of microorganisms. As a 0.12% solution, chlorhexidine gluconate mouthwash has been extensively studied for its plaque control and antimicrobial properties. Below are key details:
Mechanism of Action:
Cell Membrane Disruption: Chlorhexidine binds to bacterial cell walls, increasing permeability and causing cell death.
Plaque Inhibition: It disrupts pellicle formation, thus preventing plaque biofilm formation.
Substantivity: Chlorhexidine adheres to oral tissues (teeth, gingiva, mucosa) and remains active for up to 12 hours, ensuring sustained antimicrobial action.
Benefits in Periodontics:
Plaque Control: Effective in reducing plaque accumulation and gingival inflammation.
Periodontal Healing: Promotes healing by reducing bacterial load post-surgical interventions or scaling and root planing (SRP).
Anti-inflammatory: Minimizes gingival redness and edema.
Limitations:
Staining: May cause extrinsic staining of teeth and tongue.
Altered Taste Perception: Temporary taste alteration, especially with prolonged use.
Mucosal Irritation: Potential for minor irritation with long-term usage.
Evidence:
Kornman et al. (1991): Demonstrated that 0.12% chlorhexidine reduced gingival inflammation by over 50% in clinical studies.
Löe et al. (1975): Highlighted its superior efficacy in plaque inhibition compared to other mouthwashes. |
| Comparator Agent |
0.12% Chlorhexidine Plus Hyaluronic Acid mouthwash |
This combination mouthwash integrates chlorhexidine’s antimicrobial properties with hyaluronic acid’s wound-healing and anti-inflammatory capabilities, creating a synergistic effect beneficial for peri-implant healing.
Mechanism of Action:
Chlorhexidine Component: Provides broad-spectrum antimicrobial effects, as described above.
Hyaluronic Acid (HA):
A natural glycosaminoglycan with high water-retaining capacity.
Supports tissue repair by promoting fibroblast proliferation and extracellular matrix regeneration.
Exhibits anti-inflammatory effects by reducing cytokine production, including IL-1, which is critical in peri-implantitis and periodontal disease.
Benefits in Periodontics and Peri-implant Healing:
Enhanced Wound Healing: HA promotes angiogenesis and tissue repair, particularly beneficial after surgeries or implant placement.
Synergistic Anti-inflammatory Action: HA and chlorhexidine work together to reduce inflammation and improve clinical outcomes.
Biocompatibility: HA minimizes irritation commonly associated with prolonged chlorhexidine use.
Limitations:
Cost: Typically more expensive than chlorhexidine alone.
Availability: May not be as widely available as standalone chlorhexidine formulations.
Limited Research: While promising, long-term studies on its efficacy are limited.
Evidence:
Casale et al. (2016): Demonstrated that chlorhexidine combined with hyaluronic acid resulted in significantly better plaque reduction and faster healing in post-surgical periodontal therapy compared to chlorhexidine alone.
Pini Prato et al. (2020): Reported a notable reduction in probing pocket depth and inflammation in peri-implant patients using this combination. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Out patients at the hospital within the age group of 18-60 years.
Participants who are systemically healthy.
Participants requiring dental implant insertion in a single-tooth edentulous area with the presence of healthy teeth adjacent to the healed extracted site
Willing and able to provide written informed consent and understand the study protocol.
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| "The healing after the use of 0.12% chlorhexidine plus hyaluronic acid mouthwash is expected to demonstrate similar or superior clinical outcomes compared to the use of 0.12% chlorhexidine mouthwash (without hyaluronic acid) in peri-implant tissues." |
base line,6 weeks,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| "The cytokine (IL1) in GCF/PICF after the use of 0.12% chlorhexidine plus hyaluronic acid mouthwash is expected to reveal reduced levels compared to 0.12% chlorhexidine mouthwash (without hyaluronic acid) in peri-implant tissues." |
18 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
15/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
- 0.12% Chlorhexidine serves as the standard care, known for its antimicrobial efficacy and long-standing usage in dentistry.
- 0.12% Chlorhexidine + Hyaluronic Acid represents a novel approach, with potential benefits in enhancing tissue healing and reducing inflammation due to HA’s bioactive properties.
Both interventions will allow a comparative analysis of clinical and immunological parameters like IL-1 levels in gingival crevicular fluid (GCF), helping to determine whether the addition of hyaluronic acid provides a significant advantage over chlorhexidine alone. |