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CTRI Number  CTRI/2022/08/045119 [Registered on: 31/08/2022] Trial Registered Prospectively
Last Modified On: 30/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating the efficacy of Aloe and Neem combination gel in patients with deep pockets after scaling. 
Scientific Title of Study   CLINICAL EVALUATION AND COMPARISON OF EFFICACY OF COMBINATION GEL CONTAINING ALOE VERA AND NEEM AS AN ADJUNCT TO SCALING AND ROOT PLANNING IN CHRONIC PERIODONTITIS – An in-vivo study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sherin S Antony 
Designation  3rd year postgraduate 
Affiliation  KAHER KLE VK Institute of Dental Sciences 
Address  KAHER KLE VK Institute of Dental Sciences, NEHRU NAGAR, Belagavi.

Belgaum
KARNATAKA
590010
India 
Phone  8979555613  
Fax    
Email  meriam.jonfoo18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Renuka Metgud 
Designation  Professor, Guide 
Affiliation  KAHER KLE VK Institute of Dental Sciences 
Address  KAHER KLE VK Institute of Dental Sciences, NEHRU NAGAR, Belagavi.

Belgaum
KARNATAKA
590010
India 
Phone  9448920880  
Fax    
Email  remn@kledental-bgm.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Renuka Metgud 
Designation  Professor, Guide 
Affiliation  KAHER KLE VK Institute of Dental Sciences 
Address  KAHER KLE VK Institute of Dental Sciences, NEHRU NAGAR, Belagavi.

Bagalkot
KARNATAKA
590010
India 
Phone  9448920880  
Fax    
Email  remn@kledental-bgm.edu.in  
 
Source of Monetary or Material Support  
Combination gel will be prepared at KAHER’s KLE College of Pharmacy, Belagavi, Karnataka. 
 
Primary Sponsor  
Name  Dr Sherin S Antony 
Address  Department of Periodontics, KAHER KLE VK Institute of Dental Sciences, NEHRU NAGAR, Belagavi, Karnataka. 
Type of Sponsor  Other [] 
 
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 Sherin S Antony  KAHER KLE VK Institute of Dental Sciences  Department of periodontics, KAHER KLE VK Institute of Dental Sciences, NEHRU NAGAR, Belagavi.
Belgaum
KARNATAKA 
8979555613

meriam.jonfoo18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE KLE VKIDS  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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: aloe neem gel, Reference: herbal gels, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 2(ml), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 1 Years, anupAna/sahapAna: No, Additional Information: gel will be applied locally in deep gingival pockets
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Minimum of 20 teeth should be present.
2. Age – 20 years and above.
3. Systemically healthy patient.
4. Patients with chronic periodontitis (AAP 1999 Classification of periodontitis) having pocket probing depth of >4mm in contralateral quadrants.
5. Patients who have not undergone any form of dental treatment (non-surgical or surgical therapy) in the last 6 months including oral prophylaxis. 
 
ExclusionCriteria 
Details  1. Patient with a history of antibiotics and non-steroidal anti-inflammatory drug use in the past 6 months.
2. Pregnant women and lactating mothers.
3. Smokers and patients consuming tobacco in any form.
4. Immuno-compromised patients.
5. Patient not willing to participate in the study.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pocket Probing depth
2. clinical attachment level
3. Plaque index 
2 weeks follow up 
 
Secondary Outcome  
Outcome  TimePoints 
1. Oral hygiene maintenance,
2. Patients satisfaction 
2 weeks 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   05/09/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Periodontitis is the most common and a major public health problem due to its high prevalence which is 25% to 55% worldwide, and also because it leads to tooth loss, and also degrades the quality of life. (1) Periodontal therapy includes both mechanical and chemical therapeutic agents which help in the reduction or elimination of microbial biofilm.

Conventional plaque control (scaling and root planing [SRP] and ultrasonic debridement has reduced effectiveness because it lacks accessibility to micro-organisms in the
sub-gingival environment. (2) Adjunctive chemotherapies enhance the results at sites not responsive to conventional mechanical therapy. (2) The administrations of systemic antimicrobial drugs have failed to achieve the adequate concentration at the required sites and its frequent usage has led to bacterial resistance. (3) Local drug delivery system proves beneficial because of their ability to reach the base of the periodontal pocket and also causes sustained release of short dose of drug over a long period of time. It has shown promising results in mild and moderate chronic periodontitis. (4)

Herbal medicine contains natural phytochemicals and are highly effective substitutes to antimicrobial agents which signify an alternative approach in the preventive and
therapeutic management of oral and periodontal infections. (3) They act holistically to improve symptoms, regress the disease progression, correct imbalance and adjust the
immune system. (5) In the arena of local drug delivery, literature also shows effective use of herbs like curcumin, green tea, aloe-vera, Acacia catechu, Azadirachta indica and pomegranate. (3)

Aloe vera (Aloe barbadensis miller) belongs to the family: Liliaceae and is frequently being used as herbal medicine. (6) Aloe vera gel has an inhibitory effect on
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis which were isolated from patients with periodontitis and Bacteroides fragilis isolated from patients with dental caries. (6) Aloe vera gel has also been used as local drug delivery system in periodontal pockets and has exhibited encouraging findings in clinical parameters which resulted in improvement of periodontal condition. (7)

Neem tree known as Azadirachta indica belongs to family: Meliaceae. Various pharmacological activities such as antioxidant, antimicrobial, anti-inflammatory, anti
carcinogenic properties has been earlier reported by different parts of neem tree. (8) Neem gel when delivered as Local Drug Delivery has shown statistically significant
reduction in Plaque Index, Gingival Index, Pocket probing depth and a mean decrease in the gram positive cocci, gram negative cocci, gram positive bacilli and gram negative bacilli when compared to the control group. (9)

There have been no reported clinical studies using a combination of Aloe vera and Neem as a Local Drug Delivery agents in periodontitis. Therefore, in the present study, the
effects of a combination gel containing Aloe vera and Neem will be evaluated and compared as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

 
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