Back to results

Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

aloe vera

placebo gel

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Aloe vera

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Clinical attachment level

Secondary Outcome Measures

Change in Plaque index

Change in modified sulcus bleeding index

Change in Probing depth

Full Information

NCT ID

NCT02386020

First Posted

February 18, 2015

Last Updated

March 5, 2015

Sponsor

Government Dental College and Research Institute, Bangalore

1. Study Identification

Unique Protocol Identification Number

NCT02386020

Brief Title

Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

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 Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Government Dental College and Research Institute, Bangalore

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Aloe vera

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

aloe vera

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo gel

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Clinical attachment level

Time Frame

baseline to 6 months

Secondary Outcome Measure Information:

Title

Change in Plaque index

Time Frame

baseline to 6 months

Title

Change in modified sulcus bleeding index

Time Frame

baseline to 6 months

Title

Change in Probing depth

Time Frame

baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

We'll reach out to this number within 24 hrs