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

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ClinicalTrials.gov Identifier: NCT02437747
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Gurbani Kaur, Dr. D. Y. Patil Dental College & Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Chronic Periodontitis Drug: SRP + Aloe Procedure: SRP Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis Patients With Controlled Diabetes Mellitus
Study Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aloe vera

Arm Intervention/treatment
Experimental: SRP+ Aloe Group
Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites.
Drug: SRP + Aloe
Scaling and root planing along with aloe vera application was done
Other Name: Korphad Ghar

Sham Comparator: SRP Group
Only scaling and root planing was done on the opposite side.
Procedure: SRP
Scaling and root planing was done




Primary Outcome Measures :
  1. Clinical parameter of probing pocket depth [ Time Frame: 3 months ]
    Clinically change in the probing pocket depth.


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients age 30 - 55 years from both genders.
  2. Patients with controlled Type II Diabetes Mellitus (HbA1c < 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site.
  3. Patients on oral hypoglycaemic agents.
  4. Subjects who have not received periodontal therapy within preceding 6 months.
  5. Patients willing to comply with all study related procedures.

Exclusion Criteria:

  1. Subjects who have received antibiotic treatment in the preceding 3 months.
  2. History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products.
  3. Pregnant or lactating women.
  4. Smokers.
  5. History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes.
  6. Unwilling patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437747


Sponsors and Collaborators
Dr. D. Y. Patil Dental College & Hospital
Investigators
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Study Director: Archana Singh, MDS Dr.D.Y.Patil Vidyapeeth

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Responsible Party: Dr. Gurbani Kaur, Effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with diabetes mellitus: Randomized controlled clinical trial, Dr. D. Y. Patil Dental College & Hospital
ClinicalTrials.gov Identifier: NCT02437747     History of Changes
Other Study ID Numbers: DPU/431(7) /2014
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Dr. Gurbani Kaur, Dr. D. Y. Patil Dental College & Hospital:
clinical trial

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