Protocol summary

Summary
The aim of this study was to assess the efficacy of Aloe vera-Green tea mouthwash in reducing pain after the periodontal pocket reduction surgery. Design: randomized, double blind clinical trial (with placebo). Inclusion criterion: patients suffering generalized chronic periodontists Exclusion criteria: patients who suffered only from Gingivitis; patients with contraindications of periodontal and gingival treatments( like uncontrolled diabetes); patients who received antibiotic therapy during last months; patients who suffered from dental and masticatory system pain. Target sample size: 30. Intervention: administration of Green tea-Aloe vera efficacy on pain reduction and painkiller consumption after periodontal pocket reduction surgery in comparison to placebo group. Outcome measure: the pain perceived (based on numerical pain rating scale) and amount of painkillers consumed by patients were assessed during the first 10 days after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016082029432N1
Registration date: 2016-09-14, 1395/06/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-14, 1395/06/24
Registrant information
Name
Ehsan Tafazoli Moghadam
Name of organization / entity
Orthodontics Department, Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4449 1925
Email address
a.tafazzolimoghaddam@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of green tea- Aloe vera mouthwash in pain control following periodontal surgeries
Public title
Effectiveness of green tea-Aloe vera mouthwash on pain reduction after surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterion: patients suffering generalized chronic periodontists Exclusion criteria: patients who suffered only from Gingivitis; patients with contraindications of periodontal and gingival treatments( like uncontrolled diabetes); patients who received antibiotic therapy during last months; patients who suffered from dental and masticatory system pain.
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad university of medical sciences
City
Mashhad
Postal code
Approval date
2016-04-07, 1395/01/19
Ethics committee reference number
IR.MUMS.SD.REC.1394.107

Health conditions studied

1

Description of health condition studied
Chronic Periodontitis
ICD-10 code
K05.3
ICD-10 code description

Primary outcomes

1

Description
perceived postoperative pain
Timepoint
10 consecutive days after surgery
Method of measurement
Numeric Pain Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: Green tea - Aloevera mouthwash, 15 ml , b.i.d , for 10 consecutive days
Category
Treatment - Drugs

2

Description
Placebo : placebo mouthwash, 15 ml, b.i,d, for 10 consecutive days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Naser Sargolzae
Street address
City
Mahhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical sciences, Administration of Research and Technology
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical sciences, Daneshgah St.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical sciences, Administration of Research and Technology
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
Mashhad Uinversity of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Ehsan Tafazoli Moghadam
Position
ِD.D.S
Other areas of specialty/work
Street address
Mashhad- Kosar Blvd- Kosar 14 - Number 14
City
Mashhad
Postal code
Phone
+98 51 3881 9551
Fax
Email
a.tafazzolimoghaddam@sbmu.ac.ir; Tafazoli.ehsan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Ehsan Tafazoli Moghadam
Position
D.D.S
Other areas of specialty/work
Street address
Mashhad- kosar Blvd - kosar 14 - number 14
City
Mashhad
Postal code
Phone
+98 51 3881 9551
Fax
Email
a.tafazzolimoghaddam@sbmu.ac.ir; tafazoli.ehsan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan Tafazoli Moghadam
Position
D.D.S
Other areas of specialty/work
Street address
Mashhad- Kosar Blvd - kosar 14 - Number 14
City
Mashhad
Postal code
Phone
+98 51 3881 9551
Fax
Email
a.tafazzolimoghaddam@sbmu.ac.ir; tafazoli.ehsan@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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