Clinical trial NCT03083535: 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
Overall status: UNKNOWN
Phase: NA
Conditions: CHRONIC PERIODONTITIS
Lead sponsor: Government College of Dentistry, Indore
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: baseline
Secondary outcomes:
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: 1 week
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: 2 week
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: 4 week
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: 6 week
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: baseline
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: 1 week
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: 2 week
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: 4 week
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: 6 week
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: baseline
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: 1 week
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: 2 week
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: 4 week
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: 6 week
measure: Periodontal Probing Depth
timeFrame: baseline
measure: Periodontal Probing Depth
timeFrame: 1 week
measure: Periodontal Probing Depth
timeFrame: 2 week
measure: Periodontal Probing Depth
timeFrame: 4 week
measure: Periodontal Probing Depth
timeFrame: 6 week
measure: Clinical Attachment Levels
timeFrame: baseline
measure: Clinical Attachment Levels
timeFrame: 1 week
measure: Clinical Attachment Levels
timeFrame: 2 week
measure: Clinical Attachment Levels
timeFrame: 4 week
measure: Clinical Attachment Levels
timeFrame: 6 week
Other outcomes:
Locations:
Study officials:
affiliation: Govt. College of Dentistry Indore, M.P. India,Indore, M.P, India, 452001
name: Dr Subhash Garg, MDS
role: STUDY_CHAIR
References:
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.
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.