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Clinical and radiographic investigation of the effect of gel containing chitosan in grade II furcation involvement defects

Protocol summary

Study aim
Clinical and radiographic investigation of the effect of gel containing chitosan in grade II furcation involvement defects
Design
clinical trial has a control group with parallel and double blind groups, each group has 22 sample size, Kitset.ir site randomization process and random number option.
Settings and conduct
The study is double-blind, and the researcher, analyst, and participant do not know the contents of the gels.The intended parameters are measured at the beginning of the study and 6 months after surgery. The flap surgery procedures were performed and the lesions were randomly placed in one of the two treatment groups. Digital subtraction of images before and after treatment is done. Radiolucency is analyzed as analysis and radioopacity as bone formation or lack of Babol University
Participants/Inclusion and exclusion criteria
Inclusion: Patients with moderate to severe chronic periodontitis with grade II furcation involvement on the lingual or buccal side of the first or second molar of the lower jaw. The index plate before surgery is less than 20% and the amount of horizontal penetration of the probe is greater than or equal to 3 Exclusion criteria: systemic problems or drugs interfering with surgery and anatomical problems in the area
Intervention groups
The patients were randomly divided into two groups, case and control, and chitosan-containing or chitosan-free gel was used for them.
Main outcome variables
VPD: from the distance between the gingival margin to the point where the gingival epithelium adheres to the surface of the tooth in millimeters VCAL: the distance from the edge of the gingival margin to the CEJ in mm HPD: horizontal penetration of the probe into the furcation in mmGI: degree of redness, inflammation, bleeding Subtraction Radiography: Absence of deformation or bone loss in parallel periapical radiography and Age and gender

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211221053471N1
Registration date: 2023-12-23, 1402/10/02
Registration timing: registered_while_recruiting

Last update: 2023-12-23, 1402/10/02
Update count: 0
Registration date
2023-12-23, 1402/10/02
Registrant information
Name
Parastoo Madieh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 5446
Email address
parastoomadieh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and radiographic investigation of the effect of gel containing chitosan in grade II furcation involvement defects
Public title
Investigating the effect of gel containing chitosan in grade II furcation involvement defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with moderate to severe chronic periodontitis with grade II furcation involvement on the lingual or buccal side of the first or second molar of the lower jaw and need treatment. .Index plaque before surgery should be less than 20% The horizontal probe depth (Horizontal Probe Depth, HPD) in the involved areas is greater than or equal to 3.
Exclusion criteria:
Having a systemic disease Need for prophylactic antibiotics to prevent bacterial endocarditis Use of medications that interfere with periodontal healing smoking Presence of contraindications for periodontal surgery Teeth with anatomical complications such as CEP, bifurcation ridge, accessory canal and concavity More tooth mobility than class II Presence of decay and repair in the furcation area Presence of evidence of periapical pathology in the clinical or radiographic appearance of the tooth in question The possibility of the patient's lack of acceptable cooperation after the initial periodontal treatment Having a history of coagulation problems
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process is done based on the Kitset.ir site and the random numbers option, and in each of the samples, a gel containing chitosan and a gel without chitosan are randomly placed.According to the mentioned site, group A includes numbers 29,7,6,8,25,22,16,43,27,31,2,28,44,33,23,9,10,4,12,35,11,32 and group B including numbers 17,37,38,42,26,20,14,24,21,3,13,36,34,39,40,19,15,30,41,5,18,1 is.
Blinding (investigator's opinion)
Double blinded
Blinding description
Me and the professor of surgery, as a researcher and performing surgeries, will not have any information about the contents of the gels, nor will the data analyst and the participants have any information. What does the gel contain.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Second alley on the leftوHar St. 21, Shahabnia intersection,Babol
City
Babol
Province
Mazandaran
Postal code
4718773564
Approval date
2023-09-27, 1402/07/05
Ethics committee reference number
IR.MUBABOL.REC.1402.107

Health conditions studied

1

Description of health condition studied
grade II furcation involvement defects
ICD-10 code
XVIII
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Primary outcomes

1

Description
(Vertical probing depth) VPD: means the distance between the margin of the gum to the point where the gum epithelium adheres to the surface of the tooth, which is measured by the probe. To measure the depth of the pocket, the calibrated periodontal probe is inserted from the facial, lingual, mesial and distal surfaces of the tooth so that the tip of the probe is parallel to the longitudinal axis of the tooth, enters the gingival sulcus and the depth of the pocket is measured. The numbers obtained in the file related to Each patient is registered.
Timepoint
At the beginning of the study (before surgery) and 6 months after surgery
Method of measurement
Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged.

2

Description
(Vertical clinical attachment level) VCAL: First, the CEJ of the desired tooth is determined by a probe, the distance from the edge of the margin to this area is recorded by the probe, the difference of this number is the depth of probing VCAL.
Timepoint
At the beginning of the study (before surgery) and 6 months after surgery
Method of measurement
Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged.

3

Description
(Horizontal probing depth) HPD: is the horizontal entry of the probe into the furcation.
Timepoint
At the beginning of the study (before surgery) and 6 months after surgery
Method of measurement
Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged.

Secondary outcomes

1

Description
Gingival recession: if the gingival margin is below the CEJ, we consider its existence as positive, and if the gingival margin is above the CEJ, this parameter is recorded as absent.
Timepoint
At the beginning of the study (before surgery) and 6 months after surgery
Method of measurement
Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged.

2

Description
Gingival Index: based on the percentage of tooth surfaces. which has inflammation, determines the severity and existence of gingivitis. and Subtraction Radiography based on the formation or lack of bone formation in the parallel periapical
Timepoint
At the beginning of the study (before surgery) and 6 months after surgery
Method of measurement
Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged.

Intervention groups

1

Description
Intervention group: A gel containing chitosan is randomly placed in each of the samples.
Category
Treatment - Surgery

2

Description
Control group: Chitosan-free gel is randomly placed in each sample.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol University of Medical Sciences-Faculty of Dentistry-Department of Periodontology
Full name of responsible person
Parastoo Madieh
Street address
Second alley on the leftوHar St. 21, Shahabnia intersection,Babol
City
Babol
Province
Mazandaran
Postal code
4718773564
Phone
+98 991 151 0075
Email
parastoomadieh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hassan Alizadeh Afrozi
Street address
Second alley on the leftوHar St. 21, Shahabnia intersection,Babol
City
Babol
Province
Mazandaran
Postal code
4718773564
Phone
+98 991 151 0075
Email
parastoomadieh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parastoo Madieh
Position
resident
Latest degree
Ph.D.
Other areas of specialty/work
Periodontology resident
Street address
Second alley on the leftوHar St. 21, Shahabnia intersection,Babol
City
Babol
Province
Mazandaran
Postal code
4718773564
Phone
+98 991 151 0075
Email
parastoomadieh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parastoo Madieh
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Second alley on the leftوHar St. 21, Shahabnia intersection,Babol
City
Babol
Province
Mazandaran
Postal code
4718773564
Phone
+98 51 3840 5446
Fax
Email
parastoomadieh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parastoo Madieh
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Second alley on the leftوHar St. 21, Shahabnia intersection,Babol
City
Babol
Province
Mazandaran
Postal code
4718773564
Phone
+98 51 3840 5446
Fax
Email
parastoomadieh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data and outcome changes are available
When the data will become available and for how long
After completing the study
To whom data/document is available
All researchers related to the subject
Under which criteria data/document could be used
According to the relevant protocol
From where data/document is obtainable
Researcher in charge via e-mail
What processes are involved for a request to access data/document
E-mail and then check the reason for the need for data
Comments
Confidentiality of patients' personal information is maintained.
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