NCT01943877

Brief Summary

This study was conducted to evaluate by clinical and microbiological parameters the effect of locally delivered propolis as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

8 months

First QC Date

September 2, 2013

Last Update Submit

September 16, 2013

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in the probing pocket depth and clinical attachment level

    three time points of baseline,2 weeks, 4 weeks

Secondary Outcomes (1)

  • change in gingival index and microbiological changes

    three time points baseline, 2 weeks, 4 weeks.

Study Arms (2)

Propolis

EXPERIMENTAL
Procedure: scaling root planingDrug: Propolis

scaling and root planing

SHAM COMPARATOR
Procedure: scaling root planing

Interventions

scaling root planingPROCEDURE

scaling root planing

Propolisscaling and root planing
PropolisDRUG

experimental

Propolis

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good general health
  • chronic periodontitis
  • minimum of 20 natural teeth with at least one pocket per quadrant
  • probing depth (PD) between 5 and 8 mm.

You may not qualify if:

  • subgingival instrumentation within 3 months
  • antibiotic therapy within 3 months prior to the start of the study;
  • smokers
  • pregnant or nursing women
  • intolerance or allergy to honey products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajarajeswari Dental College and Hospital

Bangalore, Karnataka, 560060, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Propolis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR.

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 17, 2013

Study Start

December 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

IN(1)