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CTRI Number  CTRI/2024/09/074503 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Ozonated aloe vera gel in addition to teeth cleaning to cure severe gum diseases 
Scientific Title of Study   Effect of ozonated aloe vera gel application as an adjunctive to scaling and root planing in the treatment of stage II grade a periodontitis patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPedapudi Divya 
Designation  Postgraduate 
Affiliation  SIBAR INSTITUTE OF DENTAL SCIENCES 
Address  Department of Periodontology Second floor Room number-8 Sibar Institute of Dental Sciences Takkellapadu ANDHRA PRADESH 522509 India
9-2-110,Shyamala nagar 2 nd line,Guntur 9-2-110 ,Shyamala nagar 2 nd line , Guntur
Guntur
ANDHRA PRADESH
522509
India 
Phone  07330381395  
Fax    
Email  divyapedapudi998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Kishore Kumar 
Designation  Professor 
Affiliation  Sibar Institute of Dental Sciences 
Address  Department of Periodontology Second floor Room number-8 Sibar Institute of Dental Sciences Takkellapadu ANDHRA PRADESH 522509 India

Guntur
ANDHRA PRADESH
522509
India 
Phone  9000534590  
Fax    
Email  kishoreuga@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr K Kishore Kumar 
Designation  Professor 
Affiliation  Sibar Institute of Dental Sciences 
Address  Department of Periodontology Second floor Room number-8 Sibar Institute of Dental Sciences Takkellapadu ANDHRA PRADESH 522509 India

Guntur
ANDHRA PRADESH
522509
India 
Phone  9000534590  
Fax    
Email  kishoreuga@yahoo.co.in  
 
Source of Monetary or Material Support  
Sibar Institute Of Dental Sciences, Takkellapadu Guntur, Andhra Pradesh, India 522509 
 
Primary Sponsor  
Name  Pedapudi Divya 
Address  Department of Periodontology Room number 8 Sibar Institute Of Dental Sciences Takkellapadu Guntur Andhra Pradesh  
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 Pedapudi Divya  Sibar Institute of Dental Sciences  room no 8, 2nd floor, department of periodontology, Sibar insttute of dental sciences, takkellapadu, 522509
Guntur
ANDHRA PRADESH 
7095132721

divyapedapudi998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sibar Institute of Dental Sciences  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  2ml of Ozonated Aloevera gel  Aloe vera is a cactus-like plant of Liliaceae family with about 360 species containing 75 active ingredients such as vitamins, enzymes, minerals, sugars, lignins, saponins, salicylic acids, and amino acids. Bhat et al examined the clinical effects of aloe vera gel during periodontal surgeries in patients with periodontal disease after mechanical debridement, reporting that topical aloe vera gel improved periodontal status; therefore, it can be used as a topical drug in periodontal pockets. Taking into considerations of effectiveness of aloe vera and ozone The present study was planned to observe the clincal outcomes with placement Ozonated aloe vera gel as an adjunct to scaling and root planing. Here 2ml of gel is placed once in the pockets after scaling and root planing. 
Comparator Agent  placebo  2ml of non-ozonated aloevera gel is placed in the pockets as placebo. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects with Stage II Grade A periodontitis.
Subjects willing to participate in the study.
Subjects who are apparently healthy.
 
 
ExclusionCriteria 
Details  Pregnant women and lactating mothers.
Allergic drug history .
Subjects who are under antibiotic therapy.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical attachment level (CAL) gain  Baseline, 1 month, 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index
Gingival index
Probing pocket depth 
Baseline, 1 month, 2 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/10/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

 Periodontitis is the  chronic  inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the tooth supporting tissues. Gingivitis as the early stage of this disease may turn into more severe periodontitis characterized by pocket formation, alveolar bone destruction, and loss of clinical attachment level. The first treatment goal in periodontal disease is  changing or removing microbial origin and risk factors to prevent disease progression and maintain periodontal tissue health. Various host-response modulation therapies and local drug therapies have been developed to block the pathways responsible for periodontal tissue break down . Since bacterial products, immunological and inflammatory factors are involved in the pathogenesis of periodontal disease, some products as adjunctive therapy can be used to help the healing process or controlling bacterial infection. Currently, ozone therapy is gaining popularity as a modern non-invasive method of treatment , it is a powerful oxidizing agent with a high antimicrobial power against oral pathogens. Due to the fewer side effects of medicinal herbs, some studies showed green tea, Cordiaverbenacea (a native plant of Brazil coasts) and Mikanialaevigata, per se or in combination with SRP, can be beneficial in periodontitis treatment.  Aloe vera is a cactus-like plant of Liliaceae family with about 360 species containing 75 active ingredients such as vitamins, enzymes, minerals, sugars, lignins, saponins, salicylic acids, and amino acids. Bhat et al examined the clinical effects of aloe vera gel during periodontal surgeries in patients with periodontal disease after mechanical debridement, reporting that topical aloe vera gel improved periodontal status; therefore, it can be used as a topical drug in periodontal pockets. Taking into considerations  of effectiveness of aloe vera and ozone The present study was planned to observe the clincal outcomes with placement Ozonated alovera gel as an  adjunctive to scaling and root planing( SRP). At initial visit, clinical examination will be performed on each patient and all the clinical parameters will be recorded.  Patients who met the inclusion criteria are randomly divided into Group I and Group II. All the patients will receive Phase 1 therapy followed by non surgical periodontal therapy. Patients in group I will receive ozonated aloe vera gel application along with non surgical periodontal therapy where as group II patients will receive Non Ozonated aloe vera gel application with non surgical periodontal therapy.Patients were instructed not to eat, drink, or rinse for at least 30 min and refrain from chewing hard or sticky foods, brushing near the gel treated site or using inter-dental aids. All clinical parameters are recorded at 30 and 60 days visit. Reinforcement of oral hygiene instructions at each appointment will be done.

 
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