| CTRI Number |
CTRI/2025/10/096091 [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 Comparison of Octanidine and Chlorhexidine based Mouthrince |
|
Scientific Title of Study
|
Clinical Comparison of Octanidine and Chlorhexidine based Mouth rinses as an adjunct in post-periodontal flap Surgery Healing- A 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 David K |
| Designation |
Associate Professor |
| Affiliation |
manipal college of dental sciences ,mangalore |
| Address |
Deparment of Periodontology Maniapl college of dental sciences Dakshina Kannada KARNATAKA 575001 India |
| Phone |
09611362034 |
| 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
KARNATAKA 575001 India |
| Phone |
09611362034 |
| 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
KARNATAKA 575001 India |
| Phone |
09611362034 |
| Fax |
|
| Email |
david.k@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Dept of Periodontology ,Manipal college of dental sciences
Mangalore 575001 |
|
|
Primary Sponsor
|
| Name |
Dr David K |
| Address |
Department of Periodontology
Manipal college of dental sciences
Mangalore 575001
karnataka
9611362034 |
| Type of Sponsor |
Other [Sponsored by the Investigators] |
|
|
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
mangalore 575001 Dakshina Kannada KARNATAKA |
9611362034
david.k@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MCODS ,Mangalore |
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 |
.1 % Octanidine mouthwash |
Post surgical/open flap debridement mouth riinsing
Twice daily
For 14 days |
| Comparator Agent |
.1% chlorhexidine mouthwash |
post surgical /open flap debridement mouth rinsing
Twice daily
For 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(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
|
|
| ExclusionCriteria |
| Details |
(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 .1 % Octanidine 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 .12% chlorhexidine mouthwash post-periodontal flap surgery on days 3, 7, and 14 days using wound healing index.
3 To conduct both intergroup and intragroup comparisons of the outcomes.
|
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-identification.
- 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) - data available on contacting the principal investigator
Dr David k
david.k@manipal.edu
- For how long will this data be available start date provided 01-12-2026 and end date provided 01-01-2035?
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 levels 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). When Chlorhexidine mouthwash is taken over a prolonged period of time, it causes tooth discoloration, mucosal irritation, cytotoxicity, and taste alteration. Octenidine dihydrochloride (OCT), cationic surfactant molecule with antibacterial properties. It binds to negatively charged microbial surfaces and adheres tenaciously to lipid components, which breaks the cell membrane of yeast, bacteria, and fungi. There are reports of its drawback, including its unpleasant bitter taste; nonetheless, many manufacturers address this issue by adding flavourings before introducing it to the market.. With fewer reported adverse effects of octenidine hydrochloride, it may be used for a longer time than chlorhexidine. Therefore, this study aims to compare the efficacy of two mouthwashes— .1% Octanidine and .12% Chlorhexidine based mouthwashes as an adjunctive post periodontal flap surgery. |