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

NCT02437747 | Completed Phase 4 DMC

• 1 other identifier: DPU/431(7) /2014
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Chronic Periodontitis

Keywords

clinical trial

Outcome Measures

Primary Outcomes (1)

• Clinical parameter of probing pocket depth

  Clinically change in the probing pocket depth.

  3 months

Secondary Outcomes (4)

• Glycosylated haemoglobin

  3 months

• Clinical parameter of plaque index

  3 months

• Clinical parameter of gingival index

  3 months

• Clinical parameter of relative attachment level

  3 months

Study Arms (2)

SRP+ Aloe Group

EXPERIMENTAL

Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites.

Drug: SRP + Aloe

SRP Group

SHAM COMPARATOR

Only scaling and root planing was done on the opposite side.

Procedure: SRP

Interventions

SRP + Aloe DRUG

Scaling and root planing along with aloe vera application was done

Also known as: Korphad Ghar

SRP+ Aloe Group

SRP PROCEDURE

Scaling and root planing was done

SRP Group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. D. Y. Patil Dental College & Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Archana Singh, MDS

  Dr.D.Y.Patil Vidyapeeth

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 8, 2015
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 8, 2015

Record last verified: 2015-05