NCT02638740

Brief Summary

Periodontal disease is a chronic inflammatory process accompanied by destruction of Periodontium, and sometimes loss of teeth. Periodontal disease is highly prevalent especially in developing and underdeveloped countries affecting more than 80% population. Epidemiological studies have shown that about 10% of the adult population suffer from severe periodontitis (Brown et al. 1990, Gjermo 1998). Studies indicate that the periodontal lesion is not strictly a localized process but may lead to systemic alterations in immune system. Various studies confirm the microbial etiology of periodontal disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

December 20, 2015

Last Update Submit

April 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)

    2 surfaces of all tooth measured

    Baseline

Secondary Outcomes (31)

  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)

    1 week

  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)

    2 week

  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)

    4 week

  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)

    8 week

  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)

    12 week

  • +26 more secondary outcomes

Study Arms (2)

SCALING AND ROOT PLANING (SRP)

ACTIVE COMPARATOR

Scaling and root planning with ultrasonic scalar

Procedure: SCALING AND ROOT PLANING (SRP)

MUSTARD OIL AND SALT MASSAGE WITH SRP

EXPERIMENTAL

Scaling and root planing was done with ultrasonic scalar. It was followed by gum massaging with 0.32gm salt in 5ml mustard oil for 5min, twice daily for 90 days.

Procedure: SCALING AND ROOT PLANING (SRP)Procedure: MUSTARD OIL AND SALT MASSAGE WITH SRP

Interventions

Scaling and root planning done with ultrasonic scalar with reinforcement of oral hygiene measures and follow up for 90 days.

MUSTARD OIL AND SALT MASSAGE WITH SRPSCALING AND ROOT PLANING (SRP)

Scaling and root planing was done with ultrasonic scalar. It was followed by gum massaging with 0.32gm salt in 5ml mustard oil for 5min, twice daily for 90 days.

MUSTARD OIL AND SALT MASSAGE WITH SRP

Eligibility Criteria

Age28 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with moderate to severe Chronic Generalized Periodontitis
  • Not undergone any major periodontal treatment in past 6 months
  • Otherwise clinically healthy patients

You may not qualify if:

  • Any known systemic diseases specially Diabetes and other major diseases.
  • Patients on anti-inflammatory drugs or antibiotics
  • Patient allergic to any material used for the study
  • Pregnant and lactating mothers
  • Periodontal therapy in past 6 months
  • Smoker and tobacco chewer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Govt. College of Dentistry Indore, M.P. India

Indore, M.P, 452001, India

Location

Related Publications (3)

  • Quist SR, Wiswedel I, Quist J, Gollnick HP. Anti-inflammatory effects of topical formulations containing sea silt and sea salt on human skin in vivo during cutaneous microdialysis. Acta Derm Venereol. 2011 Sep;91(5):597-9. doi: 10.2340/00015555-1128. No abstract available.

    PMID: 21597673BACKGROUND
  • Singla N, Acharya S, Martena S, Singla R. Effect of oil gum massage therapy on common pathogenic oral microorganisms - A randomized controlled trial. J Indian Soc Periodontol. 2014 Jul;18(4):441-6. doi: 10.4103/0972-124X.138681.

    PMID: 25210256BACKGROUND
  • Fourel J, Falabregues R, Bonfil JJ. A clinical approach to gingival stimulation. J Periodontol. 1981 Mar;52(3):130-4. doi: 10.1902/jop.1981.52.3.130.

    PMID: 6939833BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth ExfoliationRoot Planingmustard oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • trishna Mhapsekar

    Government College of Dentistry, Indore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 20, 2015

First Posted

December 23, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations