Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline and 3 months.

Detailed Description
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Aloe vera gel was locally delivered in the periodontal pockets of ≥ 5mm bilaterally in chronic periodontitis patients with diabetes under control.(HbA1c-6.6-8.6%).The study design had two groups-one in which scaling and root planing and local delivery of aloe vera gel and the other only scaling and root planing. The evaluation of clinical parameters of PI, GI, PPD and RAL at baseline, 6 weeks and 3 months. HbA1c evaluated at baseline and 3 months.

Official Title
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Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis Patients With Controlled Diabetes Mellitus

Conditions
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Diabetes Mellitus, Chronic Periodontitis

Intervention / Treatment
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* Drug: SRP + Aloe
* Procedure: SRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 30 - 55 years from both genders. Patients with controlled Type II Diabetes Mellitus (HbA1c < 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site. Patients on oral hypoglycaemic agents. Subjects who have not received periodontal therapy within preceding 6 months. Patients willing to comply with all study related procedures. Exclusion Criteria: Subjects who have received antibiotic treatment in the preceding 3 months. History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products. Pregnant or lactating women. Smokers. History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes. Unwilling patients

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRP+ Aloe Group<br>Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites. | Drug: SRP + Aloe<br>* Scaling and root planing along with aloe vera application was done<br>* Other names: Korphad Ghar;|
| Sham Comparator: SRP Group<br>Only scaling and root planing was done on the opposite side. | Procedure: SRP<br>* Scaling and root planing was done<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical parameter of probing pocket depth | Clinically change in the probing pocket depth. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated haemoglobin | HbA1c levels evaluated at baseline and 3 months | 3 months | 
| Clinical parameter of plaque index | Change in the plaque index. | 3 months | 
| Clinical parameter of gingival index | Change in the gingival index. | 3 months | 
| Clinical parameter of relative attachment level | Change in the relative attachment level. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial