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.
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
- Conditions
- CHRONIC PERIODONTITIS
- 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 group | Role | What they receive |
|---|---|---|
| Tooth Brushing | Active comparator | Tooth brushing with dentifrice and standardized tooth brush Receives: Procedure: Tooth Brushing |
| Aloe vera massaging | Experimental | Tooth 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 massaging | Experimental | Scaling 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.
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: baseline
Secondary outcomes (24)
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: 1 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: 2 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: 4 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: 6 week
Gingival Index (Loe H and Silness J 1963)
Measured: baseline
Gingival Index (Loe H and Silness J 1963)
Measured: 1 week
Gingival Index (Loe H and Silness J 1963)
Measured: 2 week
Gingival Index (Loe H and Silness J 1963)
Measured: 4 week
Gingival Index (Loe H and Silness J 1963)
Measured: 6 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: baseline
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: 1 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: 2 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: 4 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: 6 week
Periodontal Probing Depth
Measured: baseline
Periodontal Probing Depth
Measured: 1 week
Periodontal Probing Depth
Measured: 2 week
Periodontal Probing Depth
Measured: 4 week
Periodontal Probing Depth
Measured: 6 week
Clinical Attachment Levels
Measured: baseline
Clinical Attachment Levels
Measured: 1 week
Clinical Attachment Levels
Measured: 2 week
Clinical Attachment Levels
Measured: 4 week
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.
- First posted20 Mar 2017
- Study startJan 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CHRONIC PERIODONTITISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Government College of Dentistry, Indore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neha Mansoriya, Government College of Dentistry, Indore
- Investigators
- Dr Subhash Garg, MDS, Study chair, Govt. College of Dentistry Indore, M.P. India,Indore, M.P, India, 452001
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 26501001Mangaiyarkarasi 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03083535
- Acronym / sponsor ID
- GCDI
- Conditions
- CHRONIC PERIODONTITIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Government College of Dentistry, IndoreUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tooth Brushing | Active comparator | Procedure: Tooth BrushingTooth brushing with dentifrice and standardized tooth brush |
| Aloe vera massaging | Experimental | Procedure: Tooth Brushing, Procedure: aloe vera MassagingTooth brushing with dentifrice and standardized tooth brush followed by massaging with aloe vera gel |
| SRP with aloe vera massaging | Experimental | Procedure: Tooth Brushing, Procedure: aloe vera Massaging, Procedure: SRP with aloe vera massagingScaling and root planning was done with ultrasonic scalar. It was followed by aloe vera massaging on half arch for 3 minutes daily |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth BrushingTooth Brushing with Dentifrice Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste). | Procedure or surgery | Aloe vera massaging, SRP with aloe vera massaging, Tooth Brushing |
| aloe vera MassagingTooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with aloe vera gel | Procedure or surgery | Aloe vera massaging, SRP with aloe vera massaging |
| SRP with aloe vera massagingon 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 | Procedure or surgery | SRP with aloe vera massaging |
Primary outcome
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time frame: baseline
24 secondary outcomes
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time frame: 1 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time frame: 2 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time frame: 4 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time frame: 6 week
Gingival Index (Loe H and Silness J 1963)
Time frame: baseline
Gingival Index (Loe H and Silness J 1963)
Time frame: 1 week
Gingival Index (Loe H and Silness J 1963)
Time frame: 2 week
Gingival Index (Loe H and Silness J 1963)
Time frame: 4 week
Gingival Index (Loe H and Silness J 1963)
Time frame: 6 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Time frame: baseline
Russell's Periodontal Index (Rusell's A.L, 1956)
Time frame: 1 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Time frame: 2 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Time frame: 4 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Time frame: 6 week
Periodontal Probing Depth
Time frame: baseline
Periodontal Probing Depth
Time frame: 1 week
Periodontal Probing Depth
Time frame: 2 week
Periodontal Probing Depth
Time frame: 4 week
Periodontal Probing Depth
Time frame: 6 week
Clinical Attachment Levels
Time frame: baseline
Clinical Attachment Levels
Time frame: 1 week
Clinical Attachment Levels
Time frame: 2 week
Clinical Attachment Levels
Time frame: 4 week
Clinical Attachment Levels
Time frame: 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Background: PubMed 26501001Kumar 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.
- Background: PubMed 26015726Mangaiyarkarasi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Subhash Garg, MDS study chair
Govt. College of Dentistry Indore, M.P. India,Indore, M.P, India, 452001
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.