NCT03083535

Brief Summary

Periodontal disease is a multifactorial disease caused by mainly bacterial, genetic, immunologically, and environmental factors. Chronic periodontitis, one of the widely prevalent forms of periodontal disease, is characterized by loss of attachment apparatus of the tooth; it can lead to tooth loss. Many non surgical and surgical approaches have been adapted time and again to prevent, intercept, and to treat the various forms of chronic periodontitis. But, these treatment modalities are not approachable by all individuals, because of the various factors such as: low socioeconomic status, illiteracy, high cost of the treatment, no availability of easy and uncomplicated treatment nearby etc. Considering these factors, we are still in need of preventive, practical, and affordable treatment options specially for the population of underdeveloped and developing countries.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

March 14, 2017

Last Update Submit

March 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

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

    baseline

Secondary Outcomes (24)

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

    1 week

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

    2 week

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

    4 week

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

    6 week

  • Gingival Index (Loe H and Silness J 1963)

    baseline

  • +19 more secondary outcomes

Study Arms (3)

Tooth Brushing

ACTIVE COMPARATOR

Tooth brushing with dentifrice and standardized tooth brush

Procedure: Tooth Brushing

Aloe vera massaging

EXPERIMENTAL

Tooth brushing with dentifrice and standardized tooth brush followed by massaging with aloe vera gel

Procedure: Tooth BrushingProcedure: aloe vera Massaging

SRP with aloe vera massaging

EXPERIMENTAL

Scaling and root planning was done with ultrasonic scalar. It was followed by aloe vera massaging on half arch for 3 minutes daily

Procedure: Tooth BrushingProcedure: aloe vera MassagingProcedure: SRP with aloe vera massaging

Interventions

Tooth Brushing with Dentifrice Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).

Aloe vera massagingSRP with aloe vera massagingTooth Brushing

Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with aloe vera gel

Aloe vera massagingSRP with aloe vera massaging

on one side of the arch only Scaling and Root Planing(SRP) to be done, while on the other side, after the Scaling and Root Planing massaging with aloe vera ge; shall be carried out by the patients/subjects

SRP with aloe vera massaging

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases with moderate to severe form of Generalised Chronic Periodontitis patients of any sex.
  • Patients in the age group of 35-65 years, who abide by approved protocol guidelines, and are ready to give written informed consent.

You may not qualify if:

  • Any known systemic disease which has effects on periodontium such as diabetes etc.
  • Patients on anti-inflammatory, antibiotics and perioceutics, since 3 months.
  • Patients who have known allergy to material used for the study.
  • Pregnant and lactating mothers.
  • Patients had undergone any kind of non-surgical and/or surgical periodontal therapy earlier, in past 6 months.
  • Tobacco users.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kumar A, Sunkara MS, Pantareddy I, Sudhakar S. Comparison of Plaque Inhibiting Efficacies of Aloe Vera and Propolis Tooth Gels: A Randomized PCR Study. J Clin Diagn Res. 2015 Sep;9(9):ZC01-3. doi: 10.7860/JCDR/2015/13185.6413. Epub 2015 Sep 1.

    PMID: 26501001BACKGROUND
  • Mangaiyarkarasi SP, Manigandan T, Elumalai M, Cholan PK, Kaur RP. Benefits of Aloe vera in dentistry. J Pharm Bioallied Sci. 2015 Apr;7(Suppl 1):S255-9. doi: 10.4103/0975-7406.155943.

    PMID: 26015726BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Officials

  • Dr Subhash Garg, MDS

    Govt. College of Dentistry Indore, M.P. India,Indore, M.P, India, 452001

    STUDY CHAIR

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

March 14, 2017

First Posted

March 20, 2017

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 20, 2017

Record last verified: 2017-03