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IRCT20220220054075N1 IRCT 2022-03-16 Kermanshah University of Medical Sciences Evaluation of the effect of gingival retraction with laser and retraction cord on gingival recession and marginal adaptation in crowns 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 2022-02-26 anticipated 20 Complete https://irct.ir/trial/62089 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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). N/A Marginal mismatch. Intervention 1: Intervention group: After preparation the tooth for molding the gums, we retraction the gingiva with retraction cord. Intervention 2: Intervention group: After preparation the tooth for molding the gums, we retraction the gingiva with sirona diode laser. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public abolfazl ghodrati golzar
School of Dentistry ,Shariati St., Kermanshah
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3724 8531 agh00108@gmail.com Kermanshah University of Medical Sciences scientific Sahar Raeisi
No.3 ,4th floor,kosar apartment ayatolah kashani ave ,
Kermanshah Iran (Islamic Republic of) 6713737364 +98 83 3729 4660 raissisahar0@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) 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. no limit no limit Both 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 Prevention Prevention Intervention group: After preparation the tooth for molding the gums, we retraction the gingiva with retraction cord. Intervention group: After preparation the tooth for molding the gums, we retraction the gingiva with sirona diode laser. Marginal restoration adaptation. Timepoint: before and after veneering. Method of measurement: 1-parallel Byte Wing Radiography 2- Probe 3- Silicon Replica. Gingival recession. Timepoint: before intervention and Two weeks after veneering. Method of measurement: Digital caliper. Kermanshah University of Medical Sciences Approved 2022-02-22 Ethics Committee of Kermanshah University of Medical Sciences Shahid Beheshti Boulevard - Central Building of Kermanshah Medical Sciences kermanshah Kermanshah Iran (Islamic Republic of)