Determining the effectiveness of various gingival retraction techniques included cord,paste,laser on the periodontal indicators ,after impression in fixed prosthesis:a randomized clinical trial study
Determining the effectiveness of various gingival retraction techniques included cord,paste,laser on the rate of bleeding,inflammation and gingival resorption and periodontal plaque,after impression in fixed prosthesis
Design
In this Randomized Triple blinded Clinical trial study, 60 patients with maxillary and mandibular first molar in need of crown reconstruction that have inclusion criteria and visit the prosthodontist's clinic in Kermanshah are randomly assigned to intervention groups.
Settings and conduct
Teeth in need of crown reconstruction are randomly divided into3 intervention groups.clinical treatment is done by a prosthodontist with 10 years of work experience in a dental clinic.one of gingival retraction techniques used for each group of patients. Patients were followed after 7 and14 days by another prosthodontists and student. In this triple blinded study, only the prosthodontist who insert the restorations knows about the groups and participants, outcome evaluators and result analyst were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who need their maxillary or mandibular first molar to be restored; have the opposite teeth in functional occlusion and at least one proximal contact with the adjacent teeth; have clinical sulcus depth between 2-3 mm and thick gingiva biotype; no smoking; acceptable oral hygiene and periodontally healthy (plaque index and bleeding on probing had to be below 20% previously to the prosthodontic treatment);.ready to take part in the study and sign the testimonial. Exclusion criteria: have previous periodontal surgery; have mobility in tooth; use drugs having effect on periodontium; patients have systemic disease.
Intervention groups
1.gingival retraction with cord 2.gingival retraction with paste 3.gingival retraction with laser
Main outcome variables
Recession; plaque index; gingival index; bleeding index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160213026538N6
Registration date:2021-01-07, 1399/10/18
Registration timing:registered_while_recruiting
Last update:2021-01-07, 1399/10/18
Update count:0
Registration date
2021-01-07, 1399/10/18
Registrant information
Name
Hedaiat Moradpoor
Name of organization / entity
Kermanshah University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 83 3729 6910
Email address
h.moradpour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-02, 1399/10/13
Expected recruitment end date
2021-05-03, 1400/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of various gingival retraction techniques included cord,paste,laser on the periodontal indicators ,after impression in fixed prosthesis:a randomized clinical trial study
Public title
Determining the effectiveness of various gingival retraction techniques included cord,paste,laser
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need their maxillary or mandibular first molar to be restored
have the opposite teeth in functional occlusion and at least one proximal contact with the adjacent teeth
have clinical sulcus depth between 2-3 mm and thick gingiva biotype
dont be a smoker
Acceptable oral hygiene and periodontally healthy(plaque index and bleeding on probing had to be below 20% previously to the prosthodontic treatment)
ready to take part in the study and sign the testimonial
Exclusion criteria:
have previous periodontal surgery
have mobility in tooth
use drugs having effect on periodontium
patients have systemic disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the random allocation law, after determining 60 maxillary and mandibularfirst molars based on statistical calculations, 20 cards for the cord group and 20 cards for paste group and 20 cards for laser group will be placed in a draw glass, then the cards will be dropped out randomly and without replacement and the resulting sequence will be recorded.Then,60 envelopes are prepared and each random sequence created is recorded on a card and the cards are inserted into the envelope respectively. In order to maintain a random sequence, the envelopes are numbered to the same. In the end, the door covers are enclosed in boxes and placed in a box respectively. At the time of the start of the registration of the participants, according to the order of entry of qualified participants to study, one of the envelopes are opened in sequence and the participant's assigned group is revealed
Blinding (investigator's opinion)
Double blinded
Blinding description
in this clinical trial study, only the prosthodontist who do gingival retraction techniques knows about the groups and the outcome evaluators(other prosthodontist and the calibrated examiner) are blind to the assignment of each participant in each of the study groups. Participants in the study are blind toward their own group when they are aware of the similar costs and benefits of clinical treatments based on studies. Also the result analyst, have no information about the data of each group.It should be mentioned as the retraction have no differences in appearance after do ,double blinding is available.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Boulevard, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.KUMS.REC.1399.878
Health conditions studied
1
Description of health condition studied
Gingival retraction; impression in fixed prosthesis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
recession
Timepoint
after one and two week
Method of measurement
scanned reference on first session
2
Description
gingival index
Timepoint
at the first session, after one and two week
Method of measurement
gingival index
3
Description
plaque index
Timepoint
at the first session, after one and two week
Method of measurement
plaque index
4
Description
bleeding index
Timepoint
at the first session, after one and two week
Method of measurement
bleeding index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: retraction gingiva with paste
Category
Treatment - Other
2
Description
Intervention group: retraction gingiva with laser
Category
Treatment - Other
3
Description
Intervention group: retraction gingiva with cord
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Moradpour Dental clinic
Full name of responsible person
Hedaiat Moradpour
Street address
Dabiraezam st.
City
Kermanshah
Province
Kermanshah
Postal code
6713739988
Phone
+98 83 3729 6910
Email
hedaiat.mpradpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Naeemi
Position
Under graduated student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The school of Dentistry, shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
alinaeemi420@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hedaiat Moradpoor
Position
Associate professor of Prosthodontics department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Prosthodontics, The School of Dentistry, Kermanshah University of Medical Siences, Shariati St.
City
kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3729 6910
Fax
+98 83 3729 1335
Email
h.moradpour@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Naeemi
Position
Under graduated student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The school of Dentistry, Kermanshah University of Medical Sciences, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
alinaeemi420@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available