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Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02386020
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: aloe vera Drug: placebo gel Phase 2 Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Aloe vera

Arm Intervention/treatment
Placebo Comparator: Placebo
After SRP, placebo gel was delivered subgingivally into periodontal pockets.
Drug: placebo gel
After SRP, placebo gel was delivered subgingivally into periodontal pockets.

Active Comparator: Aloe vera
After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.
Drug: aloe vera
After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.




Primary Outcome Measures :
  1. Change in Clinical attachment level [ Time Frame: baseline to 6 months ]

Secondary Outcome Measures :
  1. Change in Plaque index [ Time Frame: baseline to 6 months ]
  2. Change in modified sulcus bleeding index [ Time Frame: baseline to 6 months ]
  3. Change in Probing depth [ Time Frame: baseline to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Dr. A R Pradeep, Professor & Head, Department of Periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02386020     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/10E/2013-14
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases