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Efficacy of AloeVera Gel Gum Massaging and Adjunct to Scaling and Root Planing in Chronic Periodontitis Patients

Primary Purpose

CHRONIC PERIODONTITIS

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tooth Brushing
aloe vera Massaging
SRP with aloe vera massaging
Sponsored by
Government College of Dentistry, Indore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CHRONIC PERIODONTITIS

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Tooth Brushing

    Aloe vera massaging

    SRP with aloe vera massaging

    Arm Description

    Tooth brushing with dentifrice and standardized tooth brush

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Plaque Index (Turesky modification of Quigley Hein Index, 1970)
    Plaque Index (Turesky modification of Quigley Hein Index, 1970)
    Plaque Index (Turesky modification of Quigley Hein Index, 1970)
    Plaque Index (Turesky modification of Quigley Hein Index, 1970)
    Gingival Index (Loe H and Silness J 1963)
    Gingival Index (Loe H and Silness J 1963)
    Gingival Index (Loe H and Silness J 1963)
    Gingival Index (Loe H and Silness J 1963)
    Gingival Index (Loe H and Silness J 1963)
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Periodontal Probing Depth
    Periodontal Probing Depth
    Periodontal Probing Depth
    Periodontal Probing Depth
    Periodontal Probing Depth
    Clinical Attachment Levels
    Clinical Attachment Levels
    Clinical Attachment Levels
    Clinical Attachment Levels
    Clinical Attachment Levels

    Full Information

    First Posted
    March 14, 2017
    Last Updated
    March 17, 2017
    Sponsor
    Government College of Dentistry, Indore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03083535
    Brief Title
    Efficacy of AloeVera Gel Gum Massaging and Adjunct to Scaling and Root Planing in Chronic Periodontitis Patients
    Official Title
    To Evaluate the Efficacy of Aloe Vera Gel in Gingival Massaging and as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Government College of Dentistry, Indore

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Periodontal disease is universally prevalent. It 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. The use of medicinal plants in the prevention and treatment of the various diseases need not to be over emphasized, as their uses had been advocated in treatises: Sushruta Samhita and Charka Samhita, a long back. Now, it is a demand of time to reread and get the valuable informations for the use of Medical and Dental sciences. These information will be very valuable specially, in context of under developed and developing countries. One of the herbs -'Aloe Vera' is a very important medicinal plant. The name 'Aloe Vera' is derived from the Arabic Word "Alloeh" meaning "Shining bitter substance," while "Vera" in Latin means "true". Over the years, this plant has been known by a number of names such as 'Wand of heaven', 'Heaven's blessing, and 'the Silent healer'. Plant Aloe Vera is known to us since the ancient time which has stiff grey green lance shaped leave. These leaves hold clear gel in a central mucilaginous pulp. This polysaccharide gel is responsible for beneficial properties of Aloe Vera.1 Aloe Vera gel polysaccharide acemannan has been found to be effective in activating macrophages and resulted in improved wound healing in a rat model. A novel anti-inflammatory compound c -glucosyl chromones has been extracted from the Aloe vera gel. Antibacterial property against gram positive and gram negative bacteria has also been documented.2 Some studies have also shown its antifungal, antiviral, bactericidal, and virucidal activities. A number of investigations have attempted to relate the chemical constituents in the gel to specific biological effects, such as wound healing effect,3 skin hydration effect,4 anti ageing effec,5 anti-inflammatory effect,6 anti bacterial property,2 anti fungal property7, anti viral effect,8 immunomodulating effect,9 anti tumour effect,10 and laxative effect.11 In Dentistry, clinical applications of Aloe Vera have been seen in the treatment of Apthous ulcers, Oral lichen Planus, Alveolar osteitis, and denture adhesive.12 Moreover, several studies have shown the efficacy of Aloe Vera in treating Gingivitis.13 In another study the effect of tooth paste containing high concentration of Aloe Vera, has been observed on the reduction of plaque and gingivitis.14 In underdeveloped and developed countries the application of simple and cost effective approaches are required. Therefore, this study has been planned to evaluate the clinical efficacy of Aloe Vera in moderate to severe form of Generalized Chronic Periodontitis in Indian patients. Very few studies, which can be counted on fingers, have been conducted worldwide. Hence, this study is being taken to evaluate the Efficacy of Aloe Vera Gel in Gingival Massaging and as an Adjunct to Scaling and Root

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    CHRONIC PERIODONTITIS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tooth Brushing
    Arm Type
    Active Comparator
    Arm Description
    Tooth brushing with dentifrice and standardized tooth brush
    Arm Title
    Aloe vera massaging
    Arm Type
    Experimental
    Arm Description
    Tooth brushing with dentifrice and standardized tooth brush followed by massaging with aloe vera gel
    Arm Title
    SRP with aloe vera massaging
    Arm Type
    Experimental
    Arm Description
    Scaling and root planning was done with ultrasonic scalar. It was followed by aloe vera massaging on half arch for 3 minutes daily
    Intervention Type
    Procedure
    Intervention Name(s)
    Tooth Brushing
    Intervention Description
    Tooth Brushing with Dentifrice Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).
    Intervention Type
    Procedure
    Intervention Name(s)
    aloe vera Massaging
    Intervention Description
    Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with aloe vera gel
    Intervention Type
    Procedure
    Intervention Name(s)
    SRP with aloe vera massaging
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Plaque Index (Turesky modification of Quigley Hein Index, 1970)
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Plaque Index (Turesky modification of Quigley Hein Index, 1970)
    Time Frame
    1 week
    Title
    Plaque Index (Turesky modification of Quigley Hein Index, 1970)
    Time Frame
    2 week
    Title
    Plaque Index (Turesky modification of Quigley Hein Index, 1970)
    Time Frame
    4 week
    Title
    Plaque Index (Turesky modification of Quigley Hein Index, 1970)
    Time Frame
    6 week
    Title
    Gingival Index (Loe H and Silness J 1963)
    Time Frame
    baseline
    Title
    Gingival Index (Loe H and Silness J 1963)
    Time Frame
    1 week
    Title
    Gingival Index (Loe H and Silness J 1963)
    Time Frame
    2 week
    Title
    Gingival Index (Loe H and Silness J 1963)
    Time Frame
    4 week
    Title
    Gingival Index (Loe H and Silness J 1963)
    Time Frame
    6 week
    Title
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Time Frame
    baseline
    Title
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Time Frame
    1 week
    Title
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Time Frame
    2 week
    Title
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Time Frame
    4 week
    Title
    Russell's Periodontal Index (Rusell's A.L, 1956)
    Time Frame
    6 week
    Title
    Periodontal Probing Depth
    Time Frame
    baseline
    Title
    Periodontal Probing Depth
    Time Frame
    1 week
    Title
    Periodontal Probing Depth
    Time Frame
    2 week
    Title
    Periodontal Probing Depth
    Time Frame
    4 week
    Title
    Periodontal Probing Depth
    Time Frame
    6 week
    Title
    Clinical Attachment Levels
    Time Frame
    baseline
    Title
    Clinical Attachment Levels
    Time Frame
    1 week
    Title
    Clinical Attachment Levels
    Time Frame
    2 week
    Title
    Clinical Attachment Levels
    Time Frame
    4 week
    Title
    Clinical Attachment Levels
    Time Frame
    6 week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr Subhash Garg, MDS
    Organizational Affiliation
    Govt. College of Dentistry Indore, M.P. India,Indore, M.P, India, 452001
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26501001
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26015726
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Efficacy of AloeVera Gel Gum Massaging and Adjunct to Scaling and Root Planing in Chronic Periodontitis Patients

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