Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

NCT ID: NCT02386020

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

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).

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo gel

Intervention Type: DRUG

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

Aloe vera

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

Group Type: ACTIVE_COMPARATOR

aloe vera

Intervention Type: DRUG

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

Interventions

aloe vera

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

Intervention Type: DRUG

placebo gel

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role: lead

Responsible Party

Dr. A R Pradeep

Professor & Head, Department of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GDCRI/ACM/PG/PhD/10E/2013-14

Identifier Type: -

Identifier Source: org_study_id