(1) Objectives:
The object of the study was to evaluate clinical effects of local application of Aloe Vera gel as an adjunct to scaling and root planning in patients with chronic periodontitis.
(2) Design:
18 patients entered the split mouth clinical trial study randomly and with accidental blocks divided to case and control quadrants.
(3) Setting and conduct:
All quadrants underwent scaling and root planning. The Aloe Vera gel was injected into the pockets around the selected teeth in the test sites. The pockets were filled until the material was detected at gingival margin.
(4) Participants including major eligibility criteria:
Patients with 4 to 5 millimeters of pocket depth in at least one tooth or one area in quadrant and with positive Bop test were selected. Exclusion criteria was being allergic to Aloe Vera; smoking; mouth breathing; tongue thrusting; combined endodontic and periodontal lesions; teeth with periapical lesion; severe caries and teeth with partial impaction; ongoing orthodontic treatment; systemic disease; antibiotic consumption or periodontal treatment six months prior to the study; pocket depths of more than 5 millimeters.
(5) Intervention:
Control quadrant was similar to case site except for distilled water replacing Aloe Vera gel. For long time preservation, a periodontal dressing (Coe-Pak) was placed on treated sites for 24 hours.
(6) Main outcome variables:
Clinical parameters of plaque index, gingival index and probing depth were calculated on the base line, and on thirtieth and ninetieth days. All participants were informed about the study and an informed consent was obtained.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010318054N2
Registration date:2015-05-17, 1394/02/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-17, 1394/02/27
Registrant information
Name
Anahita Ashouri Moghaddam
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 3616
Email address
drashourimoghaddam@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Evaluation of Effects of Aloe Vera Gel Local Application As an Adjunct to Scaling and Root Planning in Patients with Chronic Periodontitis
Public title
The Effects of Aloe Vera Gel in Treating Patients with Periodontal Problems
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with 4-5 millimeters of pocket depth in at least one tooth or one area in quadrant (maxilla or mandible) and with positive Bop test
Exclusion criteria: Allergic history to Aloe Vera gel and its products; smoking habits; mouth breathing; tongue thrusting; combined endodontic and periodontal lesions; teeth with periapical lesion; severe caries and teeth with partial impaction; patients under orthodontic treatment; patients with systemic disease; systemic or local antibiotic therapy in six months prior to the study; any periodontal treatment six months prior to the study; pocket depths of more than 5 millimeters.
Age
To 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
West Beheshti Boulevard, Across from Sepah bank, Gaz Square
City
Rasht
Postal code
41938-93345
Approval date
2014-08-19, 1393/05/28
Ethics committee reference number
3930231603
Health conditions studied
1
Description of health condition studied
Decreasing of periodontal pocket depth
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Alteration of periodontal pocket depth
Timepoint
Before the study and on thirthieth and ninetieth days
Method of measurement
Comparing plaque index, gingival index and probing depth in every stage of treatment
Secondary outcomes
1
Description
Treatment of patients with chronic periodontitis
Timepoint
Clinical parameters including plaque index, gingival index, and probing depth were measured at the begining of study - before SRP - and also after thirty and ninety days in both quadrants. The changes of pocket depth, gingival index and plaque index were measured thirty and ninety days after the base line and variations of test and control sites were compared.
Method of measurement
Comparing plaque index, gingival index and probing depth in every stage of treatment
Intervention groups
1
Description
In control group, a shot of distilled water was injected in periodontal pocket of contra-lateral quadrant.
Category
Placebo
2
Description
After scaling and root planning, all patients were given a shot of aloe Vera gel in one quadrant (test site) of their periodontal pockets, then the treated areas were covered with periodontal Coe-Pak.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Guilan University of Medical Sciences
Full name of responsible person
Dr. Anahita Ashouri Moghaddam
Street address
Daneshgah Street, 2 kilometers on Fooman Highway, End of Lakan Road, Saravan Ring raod, Gaz Square.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Ms. Sosan Komaei Koma
Street address
West Beheshti Boulevard, Across from Sepah Bank, Gaz Square.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Aidin Moghani
Position
Dentistry student
Other areas of specialty/work
Street address
No 42, East Kamali Alley, Sabouri Street, Yavaran.
City
Tehran
Postal code
Phone
+98 21 2281 8152
Fax
Email
aidin_mgh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Anahita Ashouri Moghaddam
Position
Assisstant Professor
Other areas of specialty/work
Street address
Daneshgah Street, 2 kilometers on Fooman Highway, End of Lakan Road, Saravan Ring raod, Gaz Square.
City
Rasht
Postal code
Phone
+98 13 3336 3616
Fax
Email
Anahita.a.moghaddam@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Anahita Ashouri Moghaddam
Position
Assisstant professor
Other areas of specialty/work
Street address
Daneshgah street, 2 kilometers on Fooman Highway, End of Lakan Road, Saravan Ring raod, Gaz Square
City
Rasht
Postal code
Iran
Phone
+98 13 3348 6416
Fax
Email
anahita.a.moghaddam@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)