Evaluation of Local Delivery of Aloe Vera Gel as an Adjunct to Non-surgical Treatment in Patients With Chronic Periodontitis

Chronic Periodontitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615585
• Other study ID #: Aloevera-chronic periodontitis
• Status: Completed
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: October 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 30, 2020
• Est. primary completion date: June 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Other:
• Aloe vera after SRP
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.

Procedure:
• Scaling and root planing (SRP)
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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket probing depth	This was measured using a periodontal probe from the gingival crest to depth of sulcus.	up to 9 months
Primary	Attachment loss	This is measured using a periodontal point. The distance between the cemento-enamel junction and gingival attachment level	up to 9 months
Primary	Bleeding on probing	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
Primary	Plaque index	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.	up to 9 months
Primary	Gingival index	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.	up to 9 months