| CTRI Number |
CTRI/2025/10/096090 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Efficacy of Freshchlor Mouth rinse |
|
Scientific Title of Study
|
Clinical Efficacy of Freshchlor Mouth rinse in Post-periodontal flap Surgery Healing- A randomized controlled clinical trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr David K |
| Designation |
Associate Professor |
| Affiliation |
manipal college of dental sciences ,mangalore |
| Address |
Deparment of Periodontology
Maniapl college of dental sciences
manipal academy of higher education
mangalore 575001
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9611362034 |
| Fax |
|
| Email |
david.k@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr David K |
| Designation |
Associate Professor |
| Affiliation |
manipal college of dental sciences ,mangalore |
| Address |
Deparment of Periodontology
Maniapl college of dental sciences
manipal academy of higher education
mangalore 575001
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9611362034 |
| Fax |
|
| Email |
david.k@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr David K |
| Designation |
Associate Professor |
| Affiliation |
manipal college of dental sciences ,mangalore |
| Address |
Deparment of Periodontology
Maniapl college of dental sciences
manipal academy of higher education
mangalore 575001
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9611362034 |
| Fax |
|
| Email |
david.k@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Group Pharmaceuticals Ltd ,India |
|
|
Primary Sponsor
|
| Name |
Group Pharmaceutical LTD |
| Address |
Group Pharmaceutical LTD
Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 David K |
Manipal College of Dental Sciences and Hospital |
Department of Periodontology,Light House Hill Road Dakshina Kannada KARNATAKA |
9611362034
david.k@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manipal college of dental sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine .12% |
Post surgical/Open flap debridement mouth rince
Twice daily
14 days |
| Intervention |
Freshchlor mouthwash |
Post surgical/open flap debridement mouthrince
Twice daily
14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
(1) Patient who are indicated for periodontal flap surgery
(2) Systemically healthy older than 18 years
(3) With basic communication, reading and writing skills
(4) Willingness to sign an informed consent form
Exclusion criteria;
(1) Surgeries other than periodontal flap surgery
(2) Systematic diseases and psychological or medical disorders that might influence pain threshold
(5) acute intraoral pain (periodontal or endodontic pain)
(6) Hypersensitivity to the mouthwash ingredients
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria;
(1) Surgeries other than periodontal flap surgery
(2) Systematic diseases and psychological or medical disorders that might influence pain threshold
(5) acute intraoral pain (periodontal or endodontic pain)
(6) Hypersensitivity to the mouthwash ingredients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate wound healing outcomes following the use of Freshchlor plus mouthwash post-periodontal flap surgery on days 3, 7, and 14 utilizing the wound healing index,
2. To evaluate wound healing outcomes following the use of .0.2% chlorhexidine mouthwash post-periodontal flap surgery on days 3, 7, and 14 days using wound healing index.
3.To evaluate the PROM (patient reported outcome measures) among both the groups using Visual analogue scale and analgesic intake
4.To conduct both intergroup and intragroup comparisons
|
3,7,14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the PROM (patient reported outcome measures) among both the groups using Visual analogue scale and analgesic intake
|
3,7,14 days |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
01/12/2025 |
| 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="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 - 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 Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - From the principal investigator
david.k@manipal.edu
- For how long will this data be available start date provided 01-06-2026 and end date provided 01-01-2036?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Maintenance of high level of oral hygiene plays a crucial role in success of any oral surgical procedure (1). Reduction of biofilm formation, prevention of infective complications on wound site and wound stability are very important for early wound healing (2). Reduction or elimination of oral biofilms is necessary to restore gingival tissues to a healthy state especially after a surgical procedure (3). However, mechanical means are often inadequate in ensuring plaque control and preventing infection at surgical sites (2,3). So, chemical agents can be used along with mechanical plaque control methods to ensure early wound healing (2). Chlorhexidine is a widely used chemical antiplaque agent routinely prescribed to patients after common oral surgical procedures (1)(3)(4). It is a cationic bisbiguanide and has broad spectrum antimicrobial activity against gram positive bacteria, gram negative bacteria, yeast, viruses leading to chlorhexidine being a gold standard for oral biofilm prevention (3)(4). A new mouthwash containing Hydrogen peroxide .1%, lactoferrin .05% and Zinc Lactate .14% is being tried for its beneficial effects on periodontal wound healing due to the individual constituents. Lactoferrin is a known antimicrobial agent and effects biofilm formation (5,6,7) Orsi 2024 stated that Lactoferrin (Lf) is a multifunctional iron glycoprotein which is known to exert a broad-spectrum primary defense activity against bacteria, fungi, protozoa and viruses. Its iron sequestering property is at the basis of the bacteriostatic effect, (8) Hydrogen peroxide is seen to be an antibacterial agent and a wound healing promotor (9,10,11) and Zinc has an important role in wound healing. (12) H2O2 has been reported to be a reactive biochemical molecule synthesized by various cells that influences biological behavior through multiple mechanisms: alterations of membrane potential, generation of new molecules, and changing intracellular redox balance, which results in activation or inactivation of different signalling transduction pathways. Contrary to the traditional viewpoint that H2O2 probably impairs tissue through its high oxidative property, a proper level of H2O2 is considered an important requirement for normal wound healing.(11) As it is widely known that for the completion of wound healing; hemostasis by platelet activating factors, growth factors and cytokines followed by inflammatory response by the body leading to removal of bacteria, foreign bodies and damaged tissues accompanied with angiogenesis, fibroblast proliferation, collagen synthesis and maturation is absolutely necessary. (5) Therefore, this study aims to evaluate the efficacy Freshchlor + mouthwash containing Hydrogen peroxide .1%, lactoferrin .05% and Zinc Lactate .14% in post periodontal flap surgery healing in comparison with Chlorhexidine 0.2% mouthwash . |