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CTRI Number  CTRI/2024/07/070366 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A study on 22 participants per group comparing two different solutions with dressing to see which works better for removing dark spots on gums. 
Scientific Title of Study   Efficacy of Superoxidised solution and Povidone iodine solution with periodontal dressing in gingival depigmentation A split mouth randomized controlled 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 Impana H A 
Designation  PG student 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9113527309  
Fax    
Email  impanaha99.hsn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Gurupur Pai 
Designation  Professor 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9845156405  
Fax    
Email  prakashpai2007@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prakash Gurupur Pai 
Designation  Professor 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9845156405  
Fax    
Email  prakashpai2007@rediffmail.com  
 
Source of Monetary or Material Support  
KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India Pincode 574327 
 
Primary Sponsor  
Name  Dr Impana H A 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India Pincode 574327 
Type of Sponsor  Other [Self] 
 
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 Impana H A  KVG Dental College and Hospital  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA 		 9113527309

impanaha99.hsn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Povidone iodine solution  Povidone Iodine solution of 500ml is composed of Povidone-Iodine IP 5% w/v (0.5% w/v available iodine) and purified water IP q.s. After the gingival depigmentation surgical procedure with scalpel, a guaze will be soaked with povidone iodine solution of 1.5ml for 5-10 mins. The soaked guaze will be used on the wound site as an adjunct on the other arch. After removal of the guaze, with a standard syringe and a blunt angulated needle , the wound site will be irrigated for 1 min with 10-20 ml of the solution. Patient will be instructed to spit out solution after irrigation procedure. Then site will be stabilized with periodontal dressing. The duration of the procedure will be 20 mins 
Intervention  Superoxidised solution (Oxum spray)  Superoxidised solution(Oxum Spray) of 100ml is composed of 99.97% of oxidised water and 0.006% of hypochlorous acid. After the gingival depigmentation surgical procedure with scalpel, a guaze will be soaked with 1.5ml of superoxidised solution(Oxum) for 5-10mins.The soaked guaze will be used on the wound site on one arch. After removal of the guaze the wound site is flushed with superoxidised solution (Oxum Spray)of 0.5ml by spraying the solution 4 times on the wound site. Then stabilized with periodontal dressing. The duration of the procedure will be 20 mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subjects with melanin hyperpigmentation of the upper and lower gingivae and good oral hygiene
Subjects with aesthetic concerns
Subjects who have the ability to understand and accept the requirements of the study
 
 
ExclusionCriteria 
Details  Subjects with thin gingival biotype.
Subjects who have the habit of smoking.
Subjects from the control group who have initiated the habit of tobacco smoking or chewing during the course of the study.
Subjects having medical conditions that compromised tissue healing (osteoporosis,hemophilia, anemia, etc.).
Subjects undergoing treatment with an interfering medication (bisphosphonate or steroid
therapy).
Subjects who undergone radiation therapy within the last 2 years.
Subjects who are pregnant or lactating .
Subjects who have undergone any invasive periodontal therapy in the previous six months.
Unable or not willing to comply with the study protocol. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To compare the efficacy of Superoxidised solution and Povidone iodine solution in gingival depigmentation by evaluating the degree of pigmentation using Dummett oral pigmentation index in the treated areas.
2.To assess patient discomfort associated with Superoxidised solution and Povidone iodine solution during and after depigmentation procedure.
 		 1,3,5 days,1 week, 1month and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To investigate and compare postoperative healing patterns including inflammation, pain, overall recovery, following the use of Superoxidised solution and Povidone iodine solution.  1,3,5 days,1 week, 1month and 6 months 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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   N/A 
Date of First Enrollment (India)   03/01/2025 
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="0"
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 - NO
Brief Summary   Gingival pigmentation is presented as a diffuse deep purplish discolouration or as irregularly shaped brown or black patches, striae or strands. Melanin, carotene, reduced haemoglobin and oxy-haemoglobin are the prime pigments contributing to the normal colour of the gingiva . Excessive deposition of melanin located in the basal and suprabasal cell layers of the epithelium will result in gingival hyperpigmentation(Dummett,1979). Gingival hyperpigmentation is an aesthetic concern. It can be physiological or pathological. Physiological hyperpigmentation is genetic and does not pose any health concerns, whereas pathological hyperpigmentation is a health concern and can occur due to variety of reasons like endocrine disorders, ingestion of heavy metals, Kaposi’s sarcoma, smoking, etc . Gingival depigmentation can be defined as a periodontal plastic surgical procedure whereby the gingival hyperpigmentation is removed or reduced by various techniques .A variety of depigmentation techniques have been described in the literature which can be classified as surgical and non surgical or chemical methods. Surgical methods mainly include bur abrasion, scalpel surgery, electrocautery, laser ablation, cryosurgery, radiosurgery, gingivectomy. Nonsurgical methods mainly refer to chemical cauterization using alcohols, phenols, ascorbic acid . A scalpel technique is one of the first techniques employed for gingival melanin depigmentation that involves surgical removal of gingival epithelium along with a layer of underlying connective tissue, thus allowing the denuded connective tissue to heal by secondary intention . It is traditional approach which is simple, easy to perform, cost effective, with minimum discomfort and aesthetically acceptable to patient. Superoxidised solution and Povidone Iodine solution represent two distinct interventions for gingival depigmentation, each with its unique characteristics and purported advantages. It is crucial to understand the comparative effectiveness of Superoxidised solution alongside Povidone iodine solution, a more traditional approach, to provide practitioners with a comprehensive understanding of available options. Superoxidised solution , a relatively novel method, is gaining attention for its ease of application and potential efficacy.The importance of Superoxidised solution lies in its potential to offer a less invasive and more patient friendly adjunct for gingival depigmentation. The spray form allows for precise application, potentially reducing discomfort during the procedure, as it is superoxidised solution which is colourless solution, has an anti inflammatory effect , it has bactericidal, fungicidal, sporicidal properties ,reduces patient discomfort, helps in early healing of the wounds . Understanding its efficacy compared to Povidone iodine solution is pivotal for practitioners seeking to incorporate innovative and patient-centric methods into their cosmetic dentistry practices. On the other hand, Povidone Iodine solution has been a longstanding choice for depigmentation, known for its effectiveness, which acts as a disinfectant , used as an oxidizing agent ,has an antimicrobial action. However, the comparative assessment with Superoxidised solution is essential to validate its continued relevance and identify potential areas for improvement .This study is essential as it aims to fill the existing gap in the literature by directly comparing the two treatments in a controlled manner, employing a split-mouth technique. Such a design enhances the internal validity of the study, minimizing the impact of confounding variables. The comparison of Superoxidised solution and Povidone iodine solution is specifically chosen to provide practitioners with evidence-based insights when deciding on the most suitable method for gingival depigmentation, as well as patient comfort and postoperative outcomes. While various methods exist for depigmentation, there is a scarcity of comprehensive comparative studies addressing the effectiveness and postoperative aspects of Superoxidised solution and Povidone iodine solution. Henceforth this study aims to evaluate and compare the effectiveness of Superoxidised solution and Povidone iodine solution with periodontal dressing in gingival depigmentation using a split -mouth technique.  
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