Patients with chronic periodontal pocket depth of more than 5 mm requires surgical phase for treatment and one of the biggest consequences of periodontal surgery is ulceration and pain in the site of surgery that is a reason for patients refuse of this type of treatment. Based on these and positive effects of topical phenytoin in accelerating wound and periodontal skin healing and its effect on pain after surgery also, present study aimed to investigate the effect of phenytoin %1 gel on the gums wound healing and reduce pain after periodontal flap surgery. In this prospective, randomized clinical trial that is conducted in Bandar Abbas, Iran in 2015, 60 patients who were systemically healthy; non-pregnant; non-smoker and with periodontal disease symmetrically in two areas selected and Modified widman flap surgery is performed on them. In each patient an area is considered as the control area that before pocket stitching, that area with saline (solution B) are filled and on the other side, the pocket before suturing is filled with phenytoin 1% solution (solution A). On 10 days and 1 and 3 months after surgery, patients are examined. In these visits the patients are questioned about the intensity of pain in two areas (in 3 methods: VAS, option selection and Von Korff).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041533444N1
Registration date:2017-05-08, 1396/02/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-08, 1396/02/18
Registrant information
Name
Aida Rashidi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 960 5228
Email address
sarafraz@kish.sharif.edu
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2017-04-22, 1396/02/02
Expected recruitment end date
2017-10-24, 1396/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECT OF %1 PHENYTOIN SUSPENSION ON HEALING OF GINGIVAL WOUNDS AFTER FLAP SURGERY
Public title
EFFECT OF %1 PHENYTOIN SUSPENSION ON HEALING OF GINGIVAL WOUNDS AFTER FLAP SURGERY
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: systemic health; non pregnant; non smoking; need surgery in both sides and no need for bone reconstruction.
Age
From 20 years old to 63 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Hormozgan University of Medical Sciences
Street address
Hormozgan University of Medical Sciences, Chamran blvd.
City
Bandar Abbas
Postal code
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.HUMS.REC.1395.140
Health conditions studied
1
Description of health condition studied
Periodontal diseas
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
Cohesion of connective tissue
Timepoint
Before, 10 days & 3 month after surgery
Method of measurement
Clinical examination
2
Description
Pain
Timepoint
Before, 10 days & 3 month after surgery
Method of measurement
Questionnaire / Clinical observation
Secondary outcomes
1
Description
Gingival elargment
Timepoint
Before, 10 days & 3 month after surgery
Method of measurement
Clinical examination
Intervention groups
1
Description
after selected one part as test part,will use phenytoin susponsion in that part before suture
Category
Treatment - Drugs
2
Description
in other side ,will use normal salin before suture
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry clinic
Full name of responsible person
Rouhollah Etemadifar
Street address
Dr. Etemadifar Clinic, Fatemiyeh St.
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Rouhollah Etemadifar
Street address
Faculty of Dentistry, Chamran blvd.
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?