Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The present study is designed to investigate the effectiveness of AV gel local drug delivery as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic periodontitis (CP) and type 2 diabetes mellitus (DM).

Detailed Description
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BACKGROUND: Advances in the field of alternative medicine have promoted widespread use of herbal agents, like Aloe vera (AV), for both medical and dental therapy. AV has anti-inflammatory, antioxidant, antimicrobial, hypoglycaemic, healing promoting and immune boosting properties. The present study is designed to investigate the effectiveness of AV gel local drug delivery as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic periodontitis (CP) and type 2 diabetes mellitus (DM). MATERIAL AND METHODS: A total of 60 subjects with probing depth (PD) ≥5mm and clinical attachment level (CAL) ≥3mm were randomly divided into two groups. Group 1 was treated with SRP + placebo gel local drug delivery (LDD) and Group 2 with SRP + AV gel LDD. Clinical parameters including full mouth plaque index (PI), modiﬁed sulcus bleeding index (mSBI), probing depth (PD) and clinical attachment level (CAL) were recorded first at baseline and then at intervals of 3 months and 6 months.

Official Title
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Clinical Efficacy of Locally Delivered Aloe Vera Gel as an Adjunct to Non-surgical Periodontal Therapy in Chronic Periodontitis Subjects With Type 2 Diabetes Mellitus: a Randomized Controlled Clinical Trial

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: aloe vera
* Drug: placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Well-controlled type 2 DM Chronic periodontitis with moderate to deep pockets [probing depth (PD) ≥5mm and clinical attachment loss (CAL) ≥3mm] No history of antibiotic or periodontal therapy in the preceding 6 months. Exclusion Criteria: Any known disease/condition or on any medication that can affect the periodontal status Known or suspected allergy to herbal medications Systemic antimicrobial therapy Aggressive periodontitis Smokers Alcoholics Immunocompromised patients Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>After SRP, placebo gel was delivered subgingivally into periodontal pockets. | Drug: placebo gel<br>* After SRP, placebo gel was delivered subgingivally into periodontal pockets.<br>|
| Active Comparator: Aloe vera<br>After SRP, aloe vera gel was delivered subgingivally into periodontal pockets. | Drug: aloe vera<br>* After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical attachment level |  | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plaque index |  | baseline to 6 months | 
| Change in modified sulcus bleeding index |  | baseline to 6 months | 
| Change in Probing depth |  | baseline to 6 months |