NCT03169322

Brief Summary

Studies reveal association between dry conditions and decreased healing in wounds or any treatment. From these studies, it can be hypothesized that healing in mouth breathers after scaling and root planing in terms of bleeding on probing, gingival index, plaque Index, clinical attachment level, probing depth may not show as much improvement as in case of nose breathers. No study has been conducted till date to find effect of scaling and root planing in periodontitis patients among mouth breathers and nose breathers.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 25, 2017

Last Update Submit

May 25, 2017

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • BOP (Bleeding on probing)

    Bleeding on probing Bleeding on probing (BOP) has been used to clinically characterize the degree of gingival /periodontal inflammation.

    12 Weeks

Study Arms (2)

Test Group

ACTIVE COMPARATOR

patients having chronic periodontitis with mouth breathing habit will receive scaling and root planing (SRP)

Procedure: SRP

Control Group

ACTIVE COMPARATOR

Nose breathers having chronic periodontitis will receive scaling and root planing (SRP)

Procedure: SRP

Interventions

SRPPROCEDURE

patients having chronic periodontitis with mouth breathing habit will receive scaling and root planing

Control GroupTest Group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy individuals possessing ≥ 20 natural teeth.
  • Chronic periodontitis criteria as defined by division of Oral Health at the Centre for Disease Control and Prevention(CDC) in collaboration with American Academy of Periodontology(AAP)-(Page and Eke 2012) i.e. at least two or more interproximal sites with clinical attachment loss(CAL) ≥ 4mm(not on same tooth), or ≥2 interproximal sites with Pocket Depth(PD) ≥5 mm(not on same tooth).
  • BOP prevalence \>25%.

You may not qualify if:

  • Patients on anti-inflammatory drugs or antibiotics within previous 6 months of commencement of study, or on any other regular medication or mouth wash, that is likely to influence periodontal status.
  • Current or former smokers or use of tobacco in any form.
  • History of treatment with statins, glucocorticoids, anticoagulants, phenytoin, calcium channel blockers such as nifedipine, diltiazem, verapamil, felodipine; immunosuppressants such as cyclosporine; bisphosphonates or any other host modulatory drugs during last six months.
  • Non-plaque-induced gingival lesions.
  • Patients taking drugs reported to cause xerostomia such as anti-cholinergics, anti-hypertensives, analgesics, sedatives, tranquilizing agents, antihistamines.
  • A recent history of any other acute or chronic infection.
  • Pregnant and lactating women and those taking oral contraceptive drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Manpreet Kaur

    Post Graduate Institute of Dental Sciences, Rohtak. HARYANA .INDIA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tewari

CONTACT

01262283876principalpgids@yahoo.in

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

October 14, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations

IN(1)