Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

Chronic Periodontitis Clinical Trial

Official title:

Clinical Efficacy of Locally Delivered Aloe Vera Gel as an Adjunct to Non-surgical Periodontal Therapy in Chronic Periodontitis Subjects With Type 2 Diabetes Mellitus: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386020
• Other study ID #: GDCRI/ACM/PG/PhD/10E/2013-14
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 18, 2015
• Last updated: March 5, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontitis

Intervention

Drug:
• aloe vera
After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.
• placebo gel
After SRP, placebo gel was delivered subgingivally into periodontal pockets.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical attachment level		baseline to 6 months	No
Secondary	Change in Plaque index		baseline to 6 months	No
Secondary	Change in modified sulcus bleeding index		baseline to 6 months	No
Secondary	Change in Probing depth		baseline to 6 months	No