NCT02386020

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 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

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
Last Updated

March 11, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

February 18, 2015

Last Update Submit

March 5, 2015

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in Clinical attachment level

    baseline to 6 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: placebo gel

Aloe vera

ACTIVE COMPARATOR

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

Drug: aloe vera

Interventions

aloe veraDRUG

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

Aloe vera
placebo gelDRUG

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

Placebo

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
Professor & Head, Department of Periodontology

Study Record Dates

First Submitted

February 18, 2015

First Posted

March 11, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 11, 2015

Record last verified: 2015-02