Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: placebo gel; Drug: aloe vera

• Registration Number: NCT02386020
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-03-05
• Last Update Submitted: 2015-03-05
• Study First Posted: 2015-03-11
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo gel	After SRP, placebo gel was delivered subgingivally into periodontal pockets.
Aloe vera	aloe vera	After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.

Primary Outcome Measures

Name	Time	Method
Change in Clinical attachment level	baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Change in Probing depth	baseline to 6 months
Change in modified sulcus bleeding index	baseline to 6 months
Change in Plaque index	baseline to 6 months