Protocol summary
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Study aim
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evaluation of the effect of 808 and 660 nm diode lasers on the complications of crown lengthening surgery.
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Design
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The clinical trial has a control group, with parallel groups, simple blind, randomized by assigning a code to each sample.
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Settings and conduct
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The study is simple blind and patients are not aware of the assignment of the control and intervention group, the research site is School of Dentistry, Isfahan University of Medical Sciences, after clinical crown length surgery, In the intervention group (one side of the midline) diode laser irradiation with wavelength of 660 nm, power 40 mw, continuously, 30 seconds and wavelength 808 nm, power 200 mw, continuously, 25 second after surgery and 3 days later The control side (the other side of the midline) received a placebo laser and Then the healing is evaluated on the third and seventh days and the pain on the day of surgery, 1,3 and 7 days after surgery
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : patients need surgical crown length and systemically healthy
exclusion criteria: history of periodontal surgery in the past six months,poor hygiene, poor cooperation, smoking and general contraindications to laser therapy
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Intervention groups
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Intervention Group: Diode laser radiation with a wavelength of 660 nm, power 40mw, continuously, 30 seconds and wavelength 808 nm, power 200 mw, 25 second, after surgery and 3 days later
Control group: placebo laser radiation after surgery and the third day
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Main outcome variables
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clinical signs of re-epithelialization, clinical signs of inflammation, clinical signs of homeostasis, pain assessment
General information
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Reason for update
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recoed of actual recruitment start and end date of clinical trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110109005570N12
Registration date:
2021-08-23, 1400/06/01
Registration timing:
prospective
Last update:
2023-08-12, 1402/05/21
Update count:
1
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Registration date
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2021-08-23, 1400/06/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-07-06, 1400/04/15
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Expected recruitment end date
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2021-08-06, 1400/05/15
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Actual recruitment start date
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2021-09-10, 1400/06/19
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Actual recruitment end date
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2021-10-13, 1400/07/21
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Trial completion date
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2021-10-21, 1400/07/29
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Scientific title
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Evaluation of the effect of Diode Laser of 808 nm and 660 nm in tissue repair and pain due to surgical crown lengthening
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Public title
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Evaluation of the effect of laser on repair and pain caused by surgical crown lengtheningn
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Systemically healthy patients
From 25 years to 60 years
Patients who have at least two teeth with the need for surgical crown lengthening in different quadrants of the mouth and not adjacent to each other
Exclusion criteria:
Patients with a history of periodontal surgery in the past six months
Uncontrolled systemic disease
Long-term treatment with antibiotics or steroids
poor hygiene
low cooperation
smoking habit
General contraindications for laser therapy
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Age
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From 25 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Two teeth on either side of the upper or lower jaw that require crown extension surgery
Actual sample size reached:
19
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Clinical examination perform to select individuals with at least 2 teeth with the need for crown lengthening surgery in different quadrants and not in teeth adjacent to each other. Each half of the jaw is as controls of the other half. The selection of intervention and control half jaws will be randomly using a closed envelope. In such a way that on two cards of the same shape "left half jaw intervention" and the other two cards are written "right half-jaw intervention" and are placed inside four envelopes of the same shape. For each patient, one envelope is opened, intervention half jaw and consequently the control half jaw is defined. The card and envelope are returned to the envelope set for the next patient
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The patient, outcome assessor and data analyzer did not know about the assignment of the control and case groups
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-09, 1400/03/19
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1400.128
Health conditions studied
1
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Description of health condition studied
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surgical crown length
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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clinical signs of re-epithelialization
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Timepoint
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third and seventh days after surgery
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Method of measurement
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Observational, 0: there is a distance between the gingival margins, 3: the gingival margins are adjacent, 6: the gingival margin has an overlap
2
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Description
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clinical signs of inflammation
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Timepoint
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third and seventh days after surgery
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Method of measurement
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Observational, 0: redness above 50% of the length of the incision or swelling is visible, 1: redness is seen below 50% 2: redness is not seen
3
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Description
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clinical signs of haemostasis
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Timepoint
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third and seventh days after surgery
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Method of measurement
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Observational, 0. : Bleeding is seen, 1: Fibrin is seen, 2: There is no fibrin
Secondary outcomes
1
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Description
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Pain at the surgical site
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Timepoint
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Surgery day, first day, third day. Seventh day after surgery
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Method of measurement
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visual analog scale
Intervention groups
1
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Description
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After surgical crown lengthening, in case group diode laser with a wavelength of 660 nm, 40 mW power, continuously, 30 seconds and 808nm wavelength, 200mw power, continuously, 25 second laser irradiation is performed on soft tissue after suturing on the outer surface of the flap on the day of surgery and 3 days later. The control group received a placebo laser on the day of surgery and 3 days later
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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healing data on the third and seventh day and patients' pain
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When the data will become available and for how long
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Whenever necessary
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To whom data/document is available
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Available to all researchers
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Under which criteria data/document could be used
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It can be a guide for researchers with similar projects
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From where data/document is obtainable
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Department of Periodontology, School of Dentistry, University of Isfahan
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What processes are involved for a request to access data/document
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A request message will be sent as soon as it is received
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Comments
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