NCT02546804

Brief Summary

Periodontal Disease is a ubiquitous in nature affecting about 80% population of India. The Periodontal Disease is a multifactorial but the dental plaque is considered as main etiological agent.The dental plaque, a adhesive bacterial coating accumulate around and in between teeth, if not removed by effective daily brushing and flossing, plaque can cause Gum infection and tooth loss. Though, many scientific periodontal procedures are available to get the treatment but because of lack of man power and poor socioeconomic condition it is not possible for every group of population in our India.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

August 26, 2015

Last Update Submit

August 3, 2018

Conditions

GingivitisPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • Plaque Index

    4 sites of all tooth is observed

    baseline

Secondary Outcomes (14)

  • Plaque Index

    2weeks

  • Plaque Index

    4weeks

  • Plaque Index

    6weeks

  • Plaque Index

    8weeks

  • Gingival Index

    baseline

  • +9 more secondary outcomes

Study Arms (3)

HOT SALT WATER

EXPERIMENTAL

3% HOT SALT WATER , 25ml used for rinsing for 60 sec, twice daily for 60 days.

Procedure: HOT SALT WATER

POTASSIUM PERMANGANATE

EXPERIMENTAL

0.01% POTASSIUM PERMANGANATE, 10ml used for rinsing for 60 sec, twice daily for 60 days.

Procedure: POTASSIUM PERMANGANATE

CHLORHEXIDINE

ACTIVE COMPARATOR

0.2% CHLORHEXIDINE, 10ml used for rinsing for 60 sec, twice daily for 60 days.

Procedure: CHLORHEXIDINE

Interventions

HOT SALT WATERPROCEDURE

25ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.

HOT SALT WATER
POTASSIUM PERMANGANATEPROCEDURE

10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.

POTASSIUM PERMANGANATE
CHLORHEXIDINEPROCEDURE

10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.

CHLORHEXIDINE

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject of Chronic Generalized Gingivitis and Mild Generalized Periodontitis.
  • Not undergone any major periodontal treatment earlier in last 06 months .
  • Otherwise Clinically Healthy Patient.

You may not qualify if:

  • Subjects with significant systemic diseases (e.g. Diabetes Mellitus, Cancer or Coronary heart disease etc.).
  • Pregnant or lactating women.
  • Smoker.
  • Patients on anti-inflammatory drugs or antibiotics
  • Patients allergic to any material used for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agrima Singh

Indore, Madhya Pradesh, 452001, India

Location

Related Publications (2)

  • Resende MM, Rocha CA, Correa NF, Veiga RR, Passos SJ, Novo NF, Juliano Y, Damasceno CA. Tap water versus sterile saline solution in the colonisation of skin wounds. Int Wound J. 2016 Aug;13(4):526-30. doi: 10.1111/iwj.12470. Epub 2015 Jun 8.

    PMID: 26059709BACKGROUND

  • Supranoto SC, Slot DE, Addy M, Van der Weijden GA. The effect of chlorhexidine dentifrice or gel versus chlorhexidine mouthwash on plaque, gingivitis, bleeding and tooth discoloration: a systematic review. Int J Dent Hyg. 2015 May;13(2):83-92. doi: 10.1111/idh.12078. Epub 2014 Jul 24.

    PMID: 25059640BACKGROUND

MeSH Terms

Conditions

GingivitisPeriodontitis

Interventions

Potassium PermanganateChlorhexidine

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Manganese CompoundsInorganic ChemicalsPotassium CompoundsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • agrima singh

    Government College of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
P.G. Student

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 11, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

August 6, 2018

Record last verified: 2018-08

Locations

IN(1)