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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  data available on contacting the principal investigator Dr David k david.k@manipal.edu

  6. 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.

  7. 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.

 
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