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Completed

NCT Number: NCT02437747

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

SRP + Aloe

Drug

Scaling and root planing along with aloe vera application was done

Other names: Korphad Ghar

SRP

Procedure

Scaling and root planing was done

Primary outcomes

  1. Clinical parameter of probing pocket depth

    Time frame: 3 months

    Clinically change in the probing pocket depth.

Secondary outcomes

  1. Glycosylated haemoglobin

    Time frame: 3 months

    HbA1c levels evaluated at baseline and 3 months

  2. Clinical parameter of plaque index

    Time frame: 3 months

    Change in the plaque index.

  3. Clinical parameter of gingival index

    Time frame: 3 months

    Change in the gingival index.

  4. Clinical parameter of relative attachment level

    Time frame: 3 months

    Change in the relative attachment level.

Sponsors and collaborators

Lead sponsor

Dr. D. Y. Patil Dental College & Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 8, 2015
Registry last updated
May 8, 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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