To compare the effectiveness of ceramic bur with surgical scalpel for gingivectomy in fixed orthodontic patients.
Design
Totally, 40 patients with gingival enlargement who undergoing fixed orthodontic treatment in the Dental Clinic of Mashhad Faculty of Dentistry, Mashhad, Iran are selected in this study. In this single-blind, controlled clinical trial, the patients are assigned into parallel groups using random SAS computer software methods.
Settings and conduct
Patients whose undergoing orthodontic treatment and referring to the Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged range 15-25 years; non-smoking; patients with gingival enlargement despite the use of health tips and mouthwash; the gingival enlargement cannot be treated with drugs.
Exclusion criteria: Patients treatment of drug-induced gingival enlargement; pregnant and breastfeeding women.
Intervention groups
The intervention group will receive the ceramic soft tissue trimming bur method with a turbine and without cooling for gum contouring. The control group will receive surgical scalpel as a routine method for gum contouring.
A clinical trial to compare the effectiveness of ceramic bur with surgical scalpel for gingivectomy in fixed orthodontic patients
Public title
The effectiveness of ceramic bur for gingivectomy in fixed orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged range 15-25 years
Non-smoking
Patients with gingival enlargement despite the use of health tips and mouthwash
The gingival enlargement cannot be treated with drugs
Exclusion criteria:
Patients treatment of drug-induced gingival enlargement
Pregnant and breastfeeding women
Age
From 15 years old to 25 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into three groups of 20 patients with categories of 2 and 4 using the randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Accordingly, the participants were given codes and assigned into the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients whose undergoing orthodontic treatment and referring to the Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, code was allocated to each of the participants and the person responsible for data collection is blind to group allocation and the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2020-09-02, 1399/06/12
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.052
Health conditions studied
1
Description of health condition studied
Patients with gingival enlargement who undergoing fixed orthodontic
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Wound healing Index
Timepoint
2 hours, as well as 1, 3, 5, 7, and 14 days after intervention
Method of measurement
Photography images
2
Description
Gingival index
Timepoint
2 hours, as well as 1, 3, 5, 7, and 14 days after intervention
Method of measurement
Base on gingival overgrowth Index
3
Description
Gingival bleeding index
Timepoint
2 hours, as well as 1, 3, 5, 7, and 14 days after intervention
Method of measurement
Base on bleeding point index
Secondary outcomes
1
Description
Pain score
Timepoint
2 hours, as well as 1, 3, 5, 7, and 14 days after intervention
Method of measurement
Base on Visual Analogue Scale (VAS)
Intervention groups
1
Description
Intervention group: Intervention group will receive the ceramic soft tissue trimming bur method with a turbine and without cooling for gum contouring.
Category
Treatment - Surgery
2
Description
Control group: Control group will receive surgical scalpel as a routine method for gum contouring.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Zahra Siadatifar
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
szahrasiadatifar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Siadatifar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
szahrasiadatifar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Siadatifar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
szahrasiadatifar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Siadatifar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
szahrasiadatifar@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome or the like can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working at science centers and universities.
Under which criteria data/document could be used
In the case of using the results and methods of this study, the source should be mentioned.
From where data/document is obtainable
Zahra Siadatifar provides the data analysis to the applicants via email: szahrasiadatifar@gmail.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.