Evaluating the efficacy of Aloe and Neem combination gel in patients with deep pockets after scaling.

Not yet recruiting

Conditions: Chronic periodontitis,

Registration Number: CTRI/2022/08/045119

Lead Sponsor: Dr Sherin S Antony

Brief Summary: Periodontitis is the mostcommon and a major public health problem due to its high prevalence which is25% to 55% worldwide, and also because it leads to tooth loss, and alsodegrades the quality of life. (1) Periodontal therapy includes bothmechanical and chemical therapeutic agents which help in the reduction orelimination of microbial biofilm.

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

Herbal medicine containsnatural phytochemicals and are highly effective substitutes to antimicrobialagents which signify an alternative approach in the preventive and therapeuticmanagement of oral and periodontal infections. (3) They act holisticallyto improve symptoms, regress the disease progression, correct imbalance andadjust 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 usedas herbal medicine. (6) *Aloe vera* gel has an inhibitory effecton *Aggregatibacter actinomycetemcomitans*,*Porphyromonas gingivalis* which wereisolated from patients with periodontitis and Bacteroides fragilis isolated from patients with dental caries.(6) *Aloe vera* gel has alsobeen used as local drug delivery system in periodontal pockets and hasexhibited encouraging findings in clinical parameters which resulted inimprovement of periodontal condition. (7)

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

There have been no reportedclinical studies using a combination of *Aloevera* 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 andcompared as an adjunct to scaling and root planing in the treatment of chronicperiodontitis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

Minimum of 20 teeth should be present.
Age â€“ 20 years and above.
Systemically healthy patient.
Patients with chronic periodontitis (AAP 1999 Classification of periodontitis) having pocket probing depth of >4mm in contralateral quadrants.
Patients who have not undergone any form of dental treatment (non-surgical or surgical therapy) in the last 6 months including oral prophylaxis.

Exclusion Criteria

Patient with a history of antibiotics and non-steroidal anti-inflammatory drug use in the past 6 months.
Pregnant women and lactating mothers.
Smokers and patients consuming tobacco in any form.
Immuno-compromised patients.
Patient not willing to participate in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pocket Probing depth	2 weeks follow up
2. clinical attachment level	2 weeks follow up
3. Plaque index	2 weeks follow up

Secondary Outcome Measures

Name	Time	Method
1. Oral hygiene maintenance,	2. Patients satisfaction

Trial Locations

Locations (1): KAHER KLE VK Institute of Dental Sciences
🇮🇳
Belgaum, KARNATAKA, India
KAHER KLE VK Institute of Dental Sciences
🇮🇳Belgaum, KARNATAKA, India
Dr Sherin S Antony
Principal investigator
8979555613
meriam.jonfoo18@gmail.com