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NCT Number: NCT02386020

Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

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).

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aloe Vera

Drug

After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.

Placebo Gel

Drug

After SRP, placebo gel was delivered subgingivally into periodontal pockets.

Primary outcomes

  1. Change in Clinical attachment level

    Time frame: baseline to 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2015
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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