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

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Aloe vera after SRP

Scaling and root planing (SRP)

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aloe Vera + Scaling and root planing

Scaling and root planing

Arm Description

Outcomes

Primary Outcome Measures

Pocket probing depth

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

Attachment loss

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

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04615585

First Posted

October 29, 2020

Last Updated

October 29, 2020

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04615585

Brief Title

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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

July 15, 2018 (Actual)

Primary Completion Date

June 28, 2020 (Actual)

Study Completion Date

July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aloe Vera + Scaling and root planing

Arm Type

Experimental

Arm Title

Scaling and root planing

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Aloe vera after SRP

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Scaling and root planing (SRP)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pocket probing depth

Description

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

Time Frame

up to 9 months

Title

Attachment loss

Description

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

Time Frame

up to 9 months

Title

Bleeding on probing

Description

Time Frame

up to 9 months

Title

Plaque index

Description

Time Frame

up to 9 months

Title

Gingival index

Description

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.

Time Frame

up to 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: