Evaluation of the effect of gingival retraction with laser and retraction cord on marginal adaptation and gingival recession in full ceramic crowns for first premolar of maxilla – a clinical trial study
Evaluation of the effect of gingival retraction with laser and retraction cord on marginal adaptation and gingival recession
Design
Clinical trial, with parallel groups, one-way blind, randomized, on 20 patients. Randomization with Excel software was used.
Settings and conduct
Patients are visited in the dental office. Part of the work is done in the research center laboratory.
Participants/Inclusion and exclusion criteria
entry conditions:
Good general health(The patient has no systemic disease that can affect clinical outcomes)
Periodontal health(Plaque index and BOP should be below 20% before prosthetic treatment)
There is a good keratinized gum around the abutment tooth (gingival biotype is thick).
It should not have obvious signs and symptoms of bruxism or clenching
abutment teeth need reconstruction
Non-living abutment teeth that have a positive long-term prognosis based on clinical evaluations and radiology
Have sufficient periodontal support teeth for single-unit restoration and also have a minimum of looseness
The teeth have sufficient preparation length to ensure retention and resistance shapes
The patient is willing to participate in our study and sign the consent form.
No entry conditions:
The patient is unwilling or unable to observe adequate oral hygiene (index plate and BOP should be below 20%).
Basic teeth have clinical signs.
Have loose teeth of second or more degrees.
Teeth need periodontal surgery before preparing the veneer.
Parafunctional habits
Periodontitis, severe gingivitis, poor oral hygiene and high caries activity
Intervention groups
In this study, patients with the condition are divided into two groups; in the first group, gingival retraction is performed with cord and in the second group, diode laser retraction is performed.
Main outcome variables
The main outcome is marginal adaptation of restoration and the secondary outcome is gingival recession.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220220054075N1
Registration date:2022-03-16, 1400/12/25
Registration timing:registered_while_recruiting
Last update:2022-03-16, 1400/12/25
Update count:0
Registration date
2022-03-16, 1400/12/25
Registrant information
Name
sahar raeisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3729 4660
Email address
raissisahar0@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-26, 1400/12/07
Expected recruitment end date
2022-05-18, 1401/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of gingival retraction with laser and retraction cord on marginal adaptation and gingival recession in full ceramic crowns for first premolar of maxilla – a clinical trial study
Public title
Evaluation of the effect of gingival retraction with laser and retraction cord on gingival recession and marginal adaptation in crowns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Good general health(The patient has no systemic disease that can affect clinical outcomes)
Periodontal health(Plaque index and BOP should be below 20% before prosthetic treatment)
There is a good keratinized gum around the abutment tooth (gingival biotype is thick).
It should not have obvious signs and symptoms of bruxism or clenching
abutment teeth need reconstruction
Non-living abutment teeth that have a positive long-term prognosis based on clinical evaluations and radiology
Non-living abutment teeth that have a positive long-term prognosis based on clinical evaluations and radiology
The teeth have sufficient preparation length to ensure retention and resistance shapes
The patient is willing to participate in our study and sign the consent form.
Exclusion criteria:
The patient is unwilling or unable to observe adequate oral hygiene (index plate and BOP should be below 20%).
abutment teeth have clinical signs.
Have loose teeth of second or more degrees.
Teeth need periodontal surgery before preparing the crown.
Parafunctional habits
Periodontitis, severe gingivitis, poor oral hygiene and high caries activity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
A table of random numbers is used for randomization. In Excel software environment, four-digit codes are generated using the RANDBETWEEN command. Each patient is assigned a 4-digit code. If the end digit to the right of the code is 1, 2, 5, 7, 9, the patient is in the yarn group, and if the final digit is 0, 3, 4, 6, 8, the patient is in the group. The laser is placed. All codes are recorded on paper and stored in specific envelopes. The envelopes are arranged randomly and the responsible secretary who is aware of the objectives of the study will give them one of these envelopes before entering the doctor's room when reviewing the criteria for entering the study and recording patient information. The secretary is not aware of the study hypothesis and is not aware of the details of the codes for assigning to groups. The doctor will decide on the treatment process for the patient based on the specified code.
Random sequencing is performed by a statistical and epidemiological consultant using Excel software. Registration and evaluation of inclusion criteria is done by the secretary. The secretary has no information about the study hypothesis or the group code. Assignment of intervention is also done by the doctor. The doctor is aware of the group codes. The outcome assessor also has no information about how patients are coded.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention, it is not possible to blind patients and only the outcome assessor is unaware of the assignment of individuals to groups. Outcome assessment will be performed by a prosthetist other than the attending physician (evaluator).
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
Shahid Beheshti Boulevard - Central Building of Kermanshah Medical Sciences