Evaluation of Local Delivery of Aloe Vera Gel as an Adjunct to Non-surgical Treatment in Patients With Chronic Periodontitis
October 29, 2020 updated by: Nourhan M.Aly
Evaluation of Local Delivery of Aloe Vera Gel as an Adjunct to Non-surgical Treatment in Patients With Chronic Periodontitis (A Randomized, Clinical Trial)
Aim of the current study was to evaluate the effect of Aloe vera gel as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The effect of Aloe vera on treatment of chronic periodontitis will be evaluated in a randomized, controlled clinical trial.
Thirty patients with mild to moderate chronic periodontitis were divided into 2 groups: group 1 (test): will include 15 patients treated with SRP followed by application of Aloe vera gel in the periodontal pockets at day 1 and after 1 and 2 weeks, and group 2 (control) which includes 15 patients treated with SRP only.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alexandria, Egypt, 21512
- Faculty of dentistry, Alexandria university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Systemically healthy individuals.
- Patients with mild to moderate chronic periodontitis (CAL 1-4mm) according to the American Academy of Periodontology classification
Exclusion Criteria:
- Smoking and alcoholism.
- Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy, conditions leads to xerostomia).
- Patients on any medication affecting the periodontium.
- Lactating, pregnant or menopausal females.
- Patients with parafunctional habits.
- Patients with poor oral hygiene.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Aloe Vera + Scaling and root planing
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Subgingival administration of Aloe vera gel was preceded by flushing the area with saline to wash away any debris.
Aloe vera (1cc) gel was applied subgingivally using atraumatic needle.
Patients were instructed not to rinse or drink any liquid for at least 30 minutes.
The application was performed at baseline and after 1 and 2 weeks.
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Active Comparator: Scaling and root planing
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Removal of supragingival and sub-gingival calculus and debris was performed, followed by smoothing root surfaces and removing cementum or dentine that is impregnated with calculus and toxins.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pocket probing depth
Time Frame: up to 9 months
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This was measured using a periodontal probe from the gingival crest to depth of sulcus.
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up to 9 months
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Attachment loss
Time Frame: up to 9 months
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This is measured using a periodontal point.
The distance between the cemento-enamel junction and gingival attachment level
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up to 9 months
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Bleeding on probing
Time Frame: up to 9 months
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This is measured using Papillary Bleeding Index (PBI). A periodontal probe is inserted into the gingival sulcus at the base of the papilla on the mesial aspect, and then moved coronally to the papilla tip. This is repeated on the distal aspect of the papilla. The intensity of any bleeding is recorded as: Score 0 - no bleeding; Score 1 - A single discreet bleeding point; Score 2 - Several isolated bleeding points or a single line of blood appears; Score 3 - The interdental triangle fills with blood shortly after probing; Score 4 - Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus. |
up to 9 months
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Plaque index
Time Frame: up to 9 months
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This will be assessed on 4 surfaces of 6 index teeth.
Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria.
0:No plaque, 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth.
The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
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up to 9 months
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Gingival index
Time Frame: up to 9 months
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This will be assessed on 4 surfaces of 6 index teeth.
Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
The scores from the four areas of the tooth are added and divided by four in order to give the gingival index for the tooth with the following scores and criteria.
0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
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up to 9 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Fatma E Tayeb, BDS, Faculty of Dentistry, Alexandria University, Egypt
- Study Director: Mohy E El Rashidy, PhD, Faculty of Dentistry, Alexandria University, Egypt
- Study Director: Rania A Fahmy, PhD, Faculty of Dentistry, Alexandria University, Egypt
- Study Director: Mohamed S Abdel Gaffar, PhD, Faculty of Pharmacy, Alexandria University, Egypt
- Study Director: Reham A Abo Elwafa, PhD, Faculty of Medicine, Alexandria University, Egypt
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Salgado AD, Maia JL, Pereira SL, de Lemos TL, Mota OM. Antiplaque and antigingivitis effects of a gel containing Punica granatum Linn extract: a double-blind clinical study in humans. J Appl Oral Sci. 2006 Jun;14(3):162-6. doi: 10.1590/s1678-77572006000300003.
- Wiebe CB, Putnins EE. The periodontal disease classification system of the American Academy of Periodontology--an update. J Can Dent Assoc. 2000 Dec;66(11):594-7.
- Botelho MA, Nogueira NA, Bastos GM, Fonseca SG, Lemos TL, Matos FJ, Montenegro D, Heukelbach J, Rao VS, Brito GA. Antimicrobial activity of the essential oil from Lippia sidoides, carvacrol and thymol against oral pathogens. Braz J Med Biol Res. 2007 Mar;40(3):349-56. doi: 10.1590/s0100-879x2007000300010.
- Davis RH, Leitner MG, Russo JM, Byrne ME. Wound healing. Oral and topical activity of Aloe vera. J Am Podiatr Med Assoc. 1989 Nov;79(11):559-62. doi: 10.7547/87507315-79-11-559.
- Ahmadi A. Potential prevention: Aloe vera mouthwash may reduce radiation-induced oral mucositis in head and neck cancer patients. Chin J Integr Med. 2012 Aug;18(8):635-40. doi: 10.1007/s11655-012-1183-y. Epub 2012 Aug 2.
- Singh N, Hebbale M, Mhapuskar A, Ul Nisa S, Thopte S, Singh S. Effectiveness of Aloe Vera and Antioxidant along with Physiotherapy in the Management of Oral Submucous Fibrosis. J Contemp Dent Pract. 2016 Jan 1;17(1):78-84. doi: 10.5005/jp-journals-10024-1806.
- Babaee N, Zabihi E, Mohseni S, Moghadamnia AA. Evaluation of the therapeutic effects of Aloe vera gel on minor recurrent aphthous stomatitis. Dent Res J (Isfahan). 2012 Jul;9(4):381-5.
- Bhalang K, Thunyakitpisal P, Rungsirisatean N. Acemannan, a polysaccharide extracted from Aloe vera, is effective in the treatment of oral aphthous ulceration. J Altern Complement Med. 2013 May;19(5):429-34. doi: 10.1089/acm.2012.0164. Epub 2012 Dec 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2018
Primary Completion (Actual)
June 28, 2020
Study Completion (Actual)
July 30, 2020
Study Registration Dates
First Submitted
October 29, 2020
First Submitted That Met QC Criteria
October 29, 2020
First Posted (Actual)
November 4, 2020
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
October 29, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aloevera-chronic periodontitis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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