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CTRI Number  CTRI/2025/07/092094 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [mouthwash]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of two different mouthwashes on wound healing after placing implant 
Scientific Title of Study   Clinical Comparison of Efficacy of Chlorhexidine Mouthrinses with and Without Hyaluronic Acid in Post-Implant 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  Ritika Gupta 
Designation  Dental student 
Affiliation  Manipal College of Dental Sciences, Mangalore  
Address  Department of Periodontology Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal Karnataka India

Dakshina Kannada
KARNATAKA
575001
India 
Phone    
Fax    
Email  ritikagupta021002@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SANGEETA UMESH NAYAK 
Designation  Associate Professor  
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  Department of Periodontology Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal Karnataka India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09880718372  
Fax    
Email  sangeeta.nayak@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr SANGEETA UMESH NAYAK 
Designation  Associate Professor  
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  Department of Periodontology Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal Karnataka India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09880718372  
Fax    
Email  sangeeta.nayak@manipal.edu  
 
Source of Monetary or Material Support  
Manipal college of dental sciences, Mangalore, Karnataka, India. 575001 
Student study grant _IDA 
 
Primary Sponsor  
Name  PI 
Address  Department of Periodontology Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal Karnataka India  
Type of Sponsor  Other [self fund] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sangeeta Nayak  Manipal College of Dental sciences Mangalore   Department of Periodontology and dept of implantology Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal Karnataka India
Dakshina Kannada
KARNATAKA 
7973862740

ritikagupta021002@gmail.com 
DrSangeeta  Manipal College of Dental sciences, Mangalore  Department of periodontology(Room no 7) Manipal College of Dental sciences, Mangalore, India-575001
Dakshina Kannada
KARNATAKA 
08242428716

sangeeta.nayak@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Insitutional Ethics committee and review board ,MCODS,Mangalore  Approved 
Insitutional Ethics committee and review board ,MCODS,Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Missing teeth so replacement by dental implants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.2% chlorhexidine mouthwash  commercially available chlorhexidine mouthwash. The mouth rinse protocol consists of a 10 ml-rinse for 60 s twice-a-day (every 12 h) for 14 days 
Intervention  commercially available mouthwash containing chlorhexidine with hyaluronic acid. (0.2 percent CHX + 0.2 percent HA). The mouth rinse protocol consists of a 10 ml-rinse for 60 s twice-a-day (every 12 h) for 14 days.  commercially available mouthwash containing chlorhexidine with hyaluronic acid. (0.2 percent CHX + 0.2 percent HA). The mouth rinse protocol consists of a 10 ml-rinse for 60 s twice-a-day (every 12 h) for 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient who will be undergoing immediate implant or conventional implant placement

(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  Patients receiving second-stage surgeries

(2) Patient who are undergoing advanced surgical implant placement

(3)) sites with previous implant failure

(4) Systematic diseases and psychological or medical disorders that might influence pain threshold

(5) acute intraoral pain (periodontal or endodontic pain)

(6) acute infections in which oral sensitivity is affected.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
efficacy of HA on wound healing  two weeks (14 days follow Up) 
 
Secondary Outcome  
Outcome  TimePoints 
Patient acceptance and plaque index and gingival inflammation  day 7 and day 14 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="14" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/09/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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). However recent studies have shown that a combination of chlorhexidine and hyaluronic acid can give better results when prescribed for post-surgical wound healing. (1),(2),(4),(5).

As it is widely known that for the completion of wound healing; hemostasis by platand osteotting 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) Hyaluronic acid has been known to promote neo angiogenesis, fibroblast synthesis, collagen maturation along with inhibition of destructive inflammation(2)(5).It is also known to have bacteriostatic, fungistatic, anti-inflammatory, anti-edematous and  osteo-inductive properties leading to overall improvement in wound healing response(2)

Dental implants have become increasingly popular due to their effectiveness in providing long term solutions for oral rehabilitation in partially or fully edentulous patients. It is important to note that a high level of oral hygiene is an important factor for the success of dental implant surgical technique (3). Hyaluronic acid (HA) is a versatile biomaterial that has many uses in dental implant surgery, it helps to prevent infections, promote healing and ensuring health of surrounding soft tissue structures.

Therefore, this study aims to compare the efficacy of two mouthwashes—chlorhexidine alone and chlorhexidine with hyaluronic acid on  wound healing after immediate and conventional dental implant surgery.

OBJECTIVES

1.     To evaluate wound healing outcomes following the use of chlorhexidine mouthwash post-implant surgery on days 3, 7, and 14 utilizing the wound healing index,

2.      To evaluate wound healing outcomes following the use of chlorhexidine combined with hyaluronic acid mouthwash post-implant 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 of the outcomes.

Group1(control group): commercially available chlorhexidine mouthwash. The mouth rinse protocol consists of a 10 ml-rinse for 60 s twice-a-day (every 12 h) for 14 days.

Group2(experimental group): commercially available mouthwash containing chlorhexidine with hyaluronic acid. (0.2 percent CHX + 0.2 percent HA). The mouth rinse protocol consists of a 10 ml-rinse for 60 s twice-a-day (every 12 h) for 14 days.

 

Mouth rinsing will be clearly explained after surgery and patients will be advised to begin it the next morning of the surgical intervention. Each study participant will be requested rinse with 10ml allotted mouthwash 60 secs twice daily for 14 days.  Patients will also be instructed in oral hygiene maneuvers like the brushing techniques. Enrolled participants will be examined at 3, 7, and 14 days after surgery to assess the degree of wound healing and patient’s acceptance (PROM). Clinical pictures of the surgical area will also be taken using mobile phone camera of at least 12 megapixel resolution.

Re-assessment evaluation

At T3, T7, and T14, the WHI score will be clinically evaluated at treated area.

At T3, the first follow-up examination will be performed. WHI and PROM will be evaluated.

At T7 (second follow-up examination), WHI and PROM will be evaluated.

At T14 (third follow-up examination), the last registration of WHI and PROM will be evaluated.

 
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