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CHRONIC PERIODONTITISNCT03083535

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

A study testing Tooth Brushing, aloe vera Massaging and SRP with aloe vera massaging in people with CHRONIC PERIODONTITIS, run by Government College of Dentistry, Indore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 years, women only
Conditions the study is for
CHRONIC PERIODONTITIS
What is being tested?
Tooth Brushing, aloe vera Massaging and SRP with aloe vera massaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Jan 2016to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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.

Read the 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

Being tested
Tooth Brushing, aloe vera Massaging, SRP with aloe vera massaging
Medical subject headings
Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tooth BrushingProcedure or surgery

    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 MassagingProcedure or surgery

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

  • SRP with aloe vera massagingProcedure or surgery

    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

Study groups in NCT03083535
Study groupRoleWhat they receive
Tooth BrushingActive comparatorTooth brushing with dentifrice and standardized tooth brush
Receives: Procedure: Tooth Brushing
Aloe vera massagingExperimentalTooth brushing with dentifrice and standardized tooth brush followed by massaging with aloe vera gel
Receives: Procedure: Tooth Brushing; Procedure: aloe vera Massaging
SRP with aloe vera massagingExperimentalScaling and root planning was done with ultrasonic scalar. It was followed by aloe vera massaging on half arch for 3 minutes daily
Receives: Procedure: Tooth Brushing; Procedure: aloe vera Massaging; Procedure: SRP with aloe vera massaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: baseline

Secondary outcomes (24)
  1. Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    Measured: 1 week

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

    Measured: 2 week

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

    Measured: 4 week

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

    Measured: 6 week

  5. Gingival Index (Loe H and Silness J 1963)

    Measured: baseline

  6. Gingival Index (Loe H and Silness J 1963)

    Measured: 1 week

  7. Gingival Index (Loe H and Silness J 1963)

    Measured: 2 week

  8. Gingival Index (Loe H and Silness J 1963)

    Measured: 4 week

  9. Gingival Index (Loe H and Silness J 1963)

    Measured: 6 week

  10. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: baseline

  11. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: 1 week

  12. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: 2 week

  13. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: 4 week

  14. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: 6 week

  15. Periodontal Probing Depth

    Measured: baseline

  16. Periodontal Probing Depth

    Measured: 1 week

  17. Periodontal Probing Depth

    Measured: 2 week

  18. Periodontal Probing Depth

    Measured: 4 week

  19. Periodontal Probing Depth

    Measured: 6 week

  20. Clinical Attachment Levels

    Measured: baseline

  21. Clinical Attachment Levels

    Measured: 1 week

  22. Clinical Attachment Levels

    Measured: 2 week

  23. Clinical Attachment Levels

    Measured: 4 week

  24. Clinical Attachment Levels

    Measured: 6 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2017
  2. Study startJan 2016
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03083535
Sponsor's protocol ID
GCDI
Status last verified
Mar 2017
First submitted
14 Mar 2017
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26501001
  • 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.

    PubMed 26015726

Questions about this trial

What is this clinical trial studying?

A study testing Tooth Brushing, aloe vera Massaging and SRP with aloe vera massaging in people with CHRONIC PERIODONTITIS, run by Government College of Dentistry, Indore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque Index (Turesky modification of Quigley Hein Index, 1970) (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03083535, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.

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