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

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ClinicalTrials.gov Identifier: NCT03083535
Recruitment Status : Unknown
Verified March 2017 by Neha Mansoriya, Government College of Dentistry, Indore.
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Neha Mansoriya, Government College of Dentistry, Indore

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.

Condition or disease Intervention/treatment Phase
CHRONIC PERIODONTITIS Procedure: Tooth Brushing Procedure: aloe vera Massaging Procedure: SRP with aloe vera massaging Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aloe vera

Arm Intervention/treatment
Active Comparator: Tooth Brushing
Tooth brushing with dentifrice and standardized tooth brush
Procedure: Tooth Brushing
Tooth Brushing with Dentifrice Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).

Experimental: Aloe vera massaging
Tooth brushing with dentifrice and standardized tooth brush followed by massaging with aloe vera gel
Procedure: Tooth Brushing
Tooth Brushing with Dentifrice Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).

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

Experimental: SRP with aloe vera massaging
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 Brushing
Tooth Brushing with Dentifrice Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).

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

Procedure: SRP 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




Primary Outcome Measures :
  1. Plaque Index (Turesky modification of Quigley Hein Index, 1970) [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Plaque Index (Turesky modification of Quigley Hein Index, 1970) [ Time Frame: 1 week ]
  2. Plaque Index (Turesky modification of Quigley Hein Index, 1970) [ Time Frame: 2 week ]
  3. Plaque Index (Turesky modification of Quigley Hein Index, 1970) [ Time Frame: 4 week ]
  4. Plaque Index (Turesky modification of Quigley Hein Index, 1970) [ Time Frame: 6 week ]
  5. Gingival Index (Loe H and Silness J 1963) [ Time Frame: baseline ]
  6. Gingival Index (Loe H and Silness J 1963) [ Time Frame: 1 week ]
  7. Gingival Index (Loe H and Silness J 1963) [ Time Frame: 2 week ]
  8. Gingival Index (Loe H and Silness J 1963) [ Time Frame: 4 week ]
  9. Gingival Index (Loe H and Silness J 1963) [ Time Frame: 6 week ]
  10. Russell's Periodontal Index (Rusell's A.L, 1956) [ Time Frame: baseline ]
  11. Russell's Periodontal Index (Rusell's A.L, 1956) [ Time Frame: 1 week ]
  12. Russell's Periodontal Index (Rusell's A.L, 1956) [ Time Frame: 2 week ]
  13. Russell's Periodontal Index (Rusell's A.L, 1956) [ Time Frame: 4 week ]
  14. Russell's Periodontal Index (Rusell's A.L, 1956) [ Time Frame: 6 week ]
  15. Periodontal Probing Depth [ Time Frame: baseline ]
  16. Periodontal Probing Depth [ Time Frame: 1 week ]
  17. Periodontal Probing Depth [ Time Frame: 2 week ]
  18. Periodontal Probing Depth [ Time Frame: 4 week ]
  19. Periodontal Probing Depth [ Time Frame: 6 week ]
  20. Clinical Attachment Levels [ Time Frame: baseline ]
  21. Clinical Attachment Levels [ Time Frame: 1 week ]
  22. Clinical Attachment Levels [ Time Frame: 2 week ]
  23. Clinical Attachment Levels [ Time Frame: 4 week ]
  24. Clinical Attachment Levels [ Time Frame: 6 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083535


Sponsors and Collaborators
Government College of Dentistry, Indore
Investigators
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Study Chair: Dr Subhash Garg, MDS Govt. College of Dentistry Indore, M.P. India,Indore, M.P, India, 452001

Publications:
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Responsible Party: Neha Mansoriya, Dr., Government College of Dentistry, Indore
ClinicalTrials.gov Identifier: NCT03083535     History of Changes
Other Study ID Numbers: GCDI
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases