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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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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