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Evaluation of effect of phenytoin mucoadhesive paste 1% after non-surgical therapy on improvement of periodontal status in moderate to severe chronic periodontitis patients

Protocol summary

Summary
Objectives: Main purpose of this study was evaluation the effect of Phenytoin on periodontium. Design: This double blind, split mouth has been conducted on 20 patients with moderate to severe chronic periodontitis. Setting and conduct: After sampling, the average of Periodontal pocket depth along three areas of each tooth (mesial, distal, buccal), Bleeding on probing and modified gingival index (MGI) are recorded. Then for all patients, the first phase of periodontal treatment is accomplished including oral hygiene instructions, scaling and root planning. In each patient, gingival facial surfaces of posterior sextant are randomly selected, one side to apply phenytoin mucoadhesive paste 1% and the other side as a control for placing placebo. Then instructions about the application of the paste are given to all patients. Two Paste containers’ lids are selected in different colors and only the side of usage (right or left) was determined on the containers. Patient should apply the pastes twice a day after tooth-brushing and using dental floss for a week. Then patients will be visited 3 weeks after the application of topical phenytoin to evaluating the indices. major eligibility criteria including: No systemic diseases, not taking medications affecting periodontium, no history of antibiotic therapy within the last three months, having at least two similar teeth on each sextants without any decays or restorations and filling informed consent form. The exclusion criteria are included as inappropriate control plaque, irregular use of pastes and not taking part in following up appointments. Intervention: We apply phenytoin mucoadhesive paste on one side of each patient and placebo for the other side. main outcome measures (variables): Periodontal pocket depth, Bleeding on probing and modified gingival index were measured to evaluate the efficiency of drug.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014081718834N1
Registration date: 2015-02-07, 1393/11/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-07, 1393/11/18
Registrant information
Name
Nahid Nasrabadi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences of Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1621 2623
Email address
nasran@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi university of medical sciences of Yazd
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-03-18, 1393/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of phenytoin mucoadhesive paste 1% after non-surgical therapy on improvement of periodontal status in moderate to severe chronic periodontitis patients
Public title
Effect of phenytoin mucoadhesive paste 1% on periodontal parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were considered as follows: having ability to read and write, no systemic diseases such as diabetes or heart disease, not taking medications affecting periodontium (anti- hypertensives, immune suppressants and anticonvulsants), not being pregnant, no smoking, no traumatic occlusion, no history of antibiotic therapy within the last three months, having at least two similar teeth on each sextants without any decays or restorations and filling informed consent form. In addition we consulted with internist about any drug interactions to phenytoin in patients of our study. The exclusion criteria were considered as follows: 1) inappropriate control plaque during the study. 2) irregular use of pastes on the basis of given instructions 3) not taking part in following up appointments.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
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
Ethics committee of Shahid Sadoughi University of Medical Sciences of Yazd
Street address
Shahid Bahonar Square, Yazd, Iran
City
Yazd
Postal code
Approval date
2014-05-11, 1393/02/21
Ethics committee reference number
پ/17/1/31880

Health conditions studied

1

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

Primary outcomes

1

Description
pocket depth
Timepoint
4 weeeks
Method of measurement
milimeters by Williams’s periodontal probe

2

Description
bleeding on probing
Timepoint
4 weeks
Method of measurement
percentage

3

Description
modified gingival index
Timepoint
4 weeks
Method of measurement
grading by observation

Secondary outcomes

empty

Intervention groups

1

Description
In control side after the first phase of periodontal treatment was accomplished which including oral hygiene instructions, scaling and root planning, instructions about the application of the paste was given to all patients. This placebo paste is contained of 50 grams of mucoadhesive polymers including carbomer 934 and (Hydroxypropyl)methyl cellulose (1:1 w/w). subsequently, the mixed powders were gradually livigated with 50 grams of liquid paraffin.patients should use the paste on the buccal surface of determined side twice a day after tooth-brushing and using dental floss for a week.
Category
Placebo

2

Description
After the first phase of periodontal treatment was accomplished which including oral hygiene instructions, scaling and root planning, instructions about the application of the paste was given to all patients.To prepare Phenytoin paste one gram of phenytoin powder was mixed with 50 grams of mucoadhesive polymers including carbomer 934 and (Hydroxypropyl)methyl cellulose (1:1 w/w). subsequently, the mixed powders were gradually livigated with 50 grams of liquid paraffin.patients should use the paste on the buccal surface of determined side twice a day after tooth-brushing and using dental floss for a week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
periodontology department of dental school of Yazd
Full name of responsible person
Nahid Nasrabadi
Street address
Department of Periodontics, Shahid Sadoughi Dental Faculty, Dahey Fajr BLV, Imam Ave
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Sadoughi Dental Faculty
Full name of responsible person
Dr Hakime Ahadian
Street address
Shahid Sadoughi Dental Faculty, Dahey Fajr BLV, Imam Ave
City
Yazd
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 of Shahid Sadoughi Dental Faculty
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
Dental school of Yazd
Full name of responsible person
Dr Nahid Nasrabadi
Position
Resident of periodontics
Other areas of specialty/work
Street address
Department of Periodontics, Shahid Sadoughi Dental Faculty, Dahey Fajr BLV, Imam Ave
City
Yazd
Postal code
Phone
+98 35 1621 2623
Fax
Email
nasrabadi.nahid@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental school of Yazd
Full name of responsible person
Dr Nahid Nasrabadi
Position
Resident of periodontics
Other areas of specialty/work
Street address
Department of Periodontics, Shahid Sadoughi Dental Faculty, Dahey Fajr BLV, Imam Ave
City
Yazd
Postal code
Phone
+98 35 1621 2623
Fax
Email
nasrabadi.nahid@yahoo
Web page address

Person responsible for updating data

Contact

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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