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
About this trial
This is an interventional treatment trial for CHRONIC PERIODONTITIS
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.
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
NCT ID
NCT03083535
First Posted
March 14, 2017
Last Updated
March 17, 2017
Sponsor
Government College of Dentistry, Indore
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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