Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus

NCT ID: NCT02437747

Last Updated: 2015-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline and 3 months.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aloe vera gel was locally delivered in the periodontal pockets of ≥ 5mm bilaterally in chronic periodontitis patients with diabetes under control.(HbA1c-6.6-8.6%).The study design had two groups-one in which scaling and root planing and local delivery of aloe vera gel and the other only scaling and root planing.

The evaluation of clinical parameters of PI, GI, PPD and RAL at baseline, 6 weeks and 3 months.

HbA1c evaluated at baseline and 3 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Chronic Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SRP+ Aloe Group

Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites.

Group Type EXPERIMENTAL

SRP + Aloe

Intervention Type DRUG

Scaling and root planing along with aloe vera application was done

SRP Group

Only scaling and root planing was done on the opposite side.

Group Type SHAM_COMPARATOR

SRP

Intervention Type PROCEDURE

Scaling and root planing was done

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SRP + Aloe

Scaling and root planing along with aloe vera application was done

Intervention Type DRUG

SRP

Scaling and root planing was done

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Korphad Ghar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients age 30 - 55 years from both genders.
2. Patients with controlled Type II Diabetes Mellitus (HbA1c \< 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site.
3. Patients on oral hypoglycaemic agents.
4. Subjects who have not received periodontal therapy within preceding 6 months.
5. Patients willing to comply with all study related procedures.

Exclusion Criteria

1. Subjects who have received antibiotic treatment in the preceding 3 months.
2. History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products.
3. Pregnant or lactating women.
4. Smokers.
5. History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes.
6. Unwilling patients
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. D. Y. Patil Dental College & Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Gurbani Kaur

Effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with diabetes mellitus: Randomized controlled clinical trial

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Archana Singh, MDS

Role: STUDY_DIRECTOR

Dr.D.Y.Patil Vidyapeeth

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DPU/431(7) /2014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diabetes and Periodontal Therapy Trial
NCT00997178 COMPLETED PHASE3