Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

Sponsor

Government Dental College and Research Institute, Bangalore (Other)

Overall Status

Completed

CT.gov ID

NCT02386020

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis	Drug: aloe vera Drug: placebo gel	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo After SRP, placebo gel was delivered subgingivally into periodontal pockets.	Drug: placebo gel After SRP, placebo gel was delivered subgingivally into periodontal pockets.
Active Comparator: Aloe vera After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.	Drug: aloe vera After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Drug: placebo gel

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

Active Comparator: Aloe vera

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

Drug: aloe vera

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

Outcome Measures

Primary Outcome Measures

Change in Clinical attachment level [baseline to 6 months]

Secondary Outcome Measures

Change in Plaque index [baseline to 6 months]
Change in modified sulcus bleeding index [baseline to 6 months]
Change in Probing depth [baseline to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Government Dental College and Research Institute, Bangalore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. A R Pradeep, Professor & Head, Department of Periodontology, Government Dental College and Research Institute, Bangalore

ClinicalTrials.gov Identifier:

NCT02386020

Other Study ID Numbers:

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

First Posted:

Mar 11, 2015

Last Update Posted:

Mar 11, 2015

Last Verified:

Feb 1, 2015

Additional relevant MeSH terms:

Periodontitis

Chronic Periodontitis

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 11, 2015