Clinical trial NCT04615585: Evaluation of Local Delivery of Aloe Vera Gel as an Adjunct to Non-surgical Treatment in Patients With Chronic Periodontitis
Official title: Evaluation of Local Delivery of Aloe Vera Gel as an Adjunct to Non-surgical Treatment in Patients With Chronic Periodontitis (A Randomized, Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pocket probing depth
timeFrame: up to 9 months
measure: Attachment loss
timeFrame: up to 9 months
measure: Bleeding on probing
timeFrame: up to 9 months
measure: Plaque index
timeFrame: up to 9 months
measure: Gingival index
timeFrame: up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Fatma E Tayeb, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mohy E El Rashidy, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Rania A Fahmy, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy, Alexandria University, Egypt
name: Mohamed S Abdel Gaffar, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Reham A Abo Elwafa, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.