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

Sponsor
Nourhan M.Aly (Other)
Overall Status
Completed
CT.gov ID
NCT04615585
Collaborator
Alexandria University (Other)
30
1
2
24.5
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aloe vera after SRP
  • Procedure: Scaling and root planing (SRP)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jul 15, 2018
Actual Primary Completion Date :
Jun 28, 2020
Actual Study Completion Date :
Jul 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aloe Vera + Scaling and root planing

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.

Active Comparator: Scaling and root planing

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.

Outcome Measures

Primary Outcome Measures

  1. Pocket probing depth [up to 9 months]

    This was measured using a periodontal probe from the gingival crest to depth of sulcus.

  2. Attachment loss [up to 9 months]

    This is measured using a periodontal point. The distance between the cemento-enamel junction and gingival attachment level

  3. Bleeding on probing [up to 9 months]

    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.

  4. Plaque index [up to 9 months]

    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.

  5. Gingival index [up to 9 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Alexandria University Alexandria Egypt 21512

Sponsors and Collaborators

  • Nourhan M.Aly
  • Alexandria University

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nourhan M.Aly, Assistant Lecturer of Dental Public Health, University of Alexandria
ClinicalTrials.gov Identifier:
NCT04615585
Other Study ID Numbers:
  • Aloevera-chronic periodontitis
First Posted:
Nov 4, 2020
Last Update Posted:
Nov 4, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2020