The aim of this study was to determine the clinical effect of two types of periodontal dressings on wound healing. Materials and Methods: In this study, 23 patients with chronic and healthy periodontitis, systemically and with a 5-8-mm envelope requiring surgery on both sides of the jaw, will be selected. After surgery, one side of the coe-pak and on the other side of Resopac will be used. The effect of these two types of dressing will be clinically compared with examining pain, plaque accumulation, gum color, bleeding during probe and granulation tissue 7 and 14 days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050718493N2
Registration date:2017-08-01, 1396/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-01, 1396/05/10
Registrant information
Name
Leila Gholami
Name of organization / entity
Hamadan University of Medical Sciences, Faculty of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 1949
Email address
l.gholami@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of clinical effectiveness of two types of periodontal dressings on wound healing following periodontal flap surgery
Public title
Comparison of two gingival dressings on wound healing after periodontal flap surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-50; Chronic Periodontitis needing periodontal flap surgery with similar amounts of bone loss and probing depths on two sides of a Jaw; 5-8mm pocket depths; horizontal bone loss.
Exclusion criteria: Consumption of Antibiotics, corticosteroids, Hormonal drugs in the past two months; systemic contraindications for surgery; History of previous flap surgery; Aggressive periodontitis; Pregnancy and breast feeding; Diabetes and other systemic conditions affecting wound healing
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr Hesabi square
City
Zahedan
Postal code
Approval date
2014-04-27, 1393/02/07
Ethics committee reference number
6263
Health conditions studied
1
Description of health condition studied
periodontitis
ICD-10 code
k05.4
ICD-10 code description
Periodontosis
Primary outcomes
1
Description
Pain
Timepoint
7 days
Method of measurement
Visual analysis scale (VAS)
2
Description
Gingival color
Timepoint
7, 14 days
Method of measurement
Pale pink, Dark pink, Red
3
Description
Plaque acumulation
Timepoint
7, 14 day
Method of measurement
None, Mild, Moderate, Severe
4
Description
Bleeding on probing
Timepoint
7, 14 days
Method of measurement
No Bleeding, Mild, Moderate, Severe
5
Description
Granulation tissue
Timepoint
7, 14 days
Method of measurement
None, Mild, Moderate, Severe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: coe-pak dressing
Category
Treatment - Other
2
Description
Resopac gingival dressing
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, Faculty of Dentistry, Zahedan University of Medical Sciences
Full name of responsible person
Leila Gholami, Somayeh Ansari Moghadam
Street address
Department of Periodontology, Faculty of Dentistry, Mehr street
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Leila Gholami
Street address
Zahedan University of Medical Sciences, Hesabi square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Hamadan medical university
Full name of responsible person
Leila Gholami
Position
Assistant professor
Other areas of specialty/work
Street address
Park crossroad, Faculty of dentistry
City
Hamadan
Postal code
Phone
+98 81 3824 1949
Fax
Email
l.gholami@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Leila Gholami
Position
Assistant professor
Other areas of specialty/work
Street address
park crossroad,
City
Hamadan
Postal code
Phone
+98 81 3824 1949
Fax
Email
l.gholami@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Leila Gholami
Position
Asssistant professor
Other areas of specialty/work
Street address
Park Crossroad, Faculty of Dentistry
City
Hamadan
Postal code
Phone
+98 81 3824 1949
Fax
Email
l.gholami@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)