NCT02462993

Brief Summary

Background: Aloe vera is considered to be the most promising and high-ranking agent as an all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

May 29, 2015

Last Update Submit

June 3, 2015

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in Relative Attachment Loss was taken as the primary outcome

    3 months

Secondary Outcomes (2)

  • Change in Probing depth

    3 months

  • Change in number of microbial species

    3 months

Study Arms (2)

Aloe vera group

EXPERIMENTAL

Group recieving scaling and root planing and aloe vera gel local drug delivery

Drug: Aloe Vera

SRP group

NO INTERVENTION

Group recieving only scaling and root planing

Interventions

Aloe VeraDRUG

Local drug delivery of aloe vera gel

Aloe vera group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with age group between 30 - 60 years from both sexes.
  • Chronic periodontitis patients with at least 1 pair of periodontal pocket ≥ 5mm in contra-lateral quadrants.

You may not qualify if:

  • Subjects who have received antibiotic treatment in the preceding 6 months.
  • Patients with history of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any herbal products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bhat G, Kudva P, Dodwad V. Aloe vera: Nature's soothing healer to periodontal disease. J Indian Soc Periodontol. 2011 Jul;15(3):205-9. doi: 10.4103/0972-124X.85661.

    PMID: 22028505RESULT

  • Perinetti G, Paolantonio M, Cordella C, D'Ercole S, Serra E, Piccolomini R. Clinical and microbiological effects of subgingival administration of two active gels on persistent pockets of chronic periodontitis patients. J Clin Periodontol. 2004 Apr;31(4):273-81. doi: 10.1111/j.1600-051x.2004.00481.x.

    PMID: 15016256RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Krupa H Pathak

    Post graduate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 4, 2015

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

May 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06