Protocol summary

Summary
The Purpose of this study was to evaluate the efficacy of concentrated honey in wound healing process after MWF surgery and its effects on gingival and plaque index. In this double blind crossover clinical trial, 10 patients needed MWF surgery minimally in two sextants areas of the mouth were recruited. In the intervention group, honey was applied after surgery, three times a day and each time 15cc of honey was placed on the surgery zone and rinsed with normal saline for 30 seconds after 30 minute. In the next surgery, patient was placed in the control group and the equal volume of normal saline was used to wash his mouth three times a day for 30 seconds. Loe & Sillness gingival index and Sillness & Loe plaque index were measured on days 0, 1, 3, and 7. Landrey healing index was measured in days 1, 3, and 7 after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901192547N2
Registration date: 2010-05-15, 1389/02/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-05-15, 1389/02/25
Registrant information
Name
Arash Poorsattar
Name of organization / entity
Babol University of Medical Sciences (BUMS)
Country
Iran (Islamic Republic of)
Phone
+98 15 1321 6283
Email address
a.poorsattar@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy, Babol University of Medical Sciences
Expected recruitment start date
2005-12-01, 1384/09/10
Expected recruitment end date
2007-12-01, 1386/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Thymus concentrated honey in wound healing process after periodontal surgery
Public title
Effects of honey on wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: moderate periodontitis and 4-6 mm PPD who required MWF at least in two sextants. Exclusion criteria: Presence of any systemic diseases, antibiotic cunsumption or corton or any systemic medications within last month, smoking within last 2 years and pregnancy
Age
From 35 years old to 40 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Ganj Afrooz ave.
City
Babol
Postal code
Approval date
empty
Ethics committee reference number
2046

Health conditions studied

1

Description of health condition studied
Wound Healing in pulp and periapical tissues
ICD-10 code
K04.0
ICD-10 code description
chronic (hyperplastic)(ulcerative)

Primary outcomes

1

Description
wound healing
Timepoint
days 1, 3 and 7 after surgery
Method of measurement
Landry healing index

Secondary outcomes

1

Description
Plaque index
Timepoint
Days 0, 1, 3 and 7 after surgery
Method of measurement
Sillness& Loe

2

Description
Gingival index
Timepoint
Days 0, 1, 3 and 7 after surgery
Method of measurement
Sillness& Loe

Intervention groups

1

Description
Thymus concentrated honey (three times a day and each time 15cc of honey placed on the surgery zone and rinsed with normal saline for 30 seconds after 30 minute)
Category
Treatment - Drugs

2

Description
normal saline (washing mouth three times a day for 30 seconds)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodontology ward, Babol University of Medical Sciences
Full name of responsible person
Street address
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy of Babol university of Medcial Sciences
Full name of responsible person
Dr. Vahid Abbasi
Street address
Ganj Afrooz Ave., Dentistry school
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Babol university of Medcial 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
Babol University of Medcial Sciences
Full name of responsible person
Arash Poorsattar Bejeh Mir
Position
Dentistry student
Other areas of specialty/work
Street address
dentistry school, Babol university of Medcial Sciences,Ganj Arooz ave.
City
Babol
Postal code
Phone
+98 15 1321 6383
Fax
Email
a.poorsattar@mubabol.ac.ir, arashpoorsattar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medcial Sciences
Full name of responsible person
Dr. Mahmoud Khosravi
Position
Assistant professor, Implantologist & periodontologist
Other areas of specialty/work
Street address
Dentistry School, Babol university of Medcial Sciences, Ganj Afrooz Ave.
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
m.khosravi@mubabol.ac.ir, dr_khosravi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed-Mohammad Fereshtehnejad
Position
General Practitioner
Other areas of specialty/work
Street address
Central department, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8805 2265
Fax
Email
mohammad@stu.iums.ac.ir
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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