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Evaluation of the effect of using a diode laser on the healing process of periapical lesions of teeth after endodontic retreatment: A controlled clinical trial study

Protocol summary

Study aim
Evaluation of effect of diode laser in the healing process of periapical lesions of single channel anterior teeth with root retreatment
Design
A controlled, single-blind, randomized clinical trial
Settings and conduct
Selection of 24 patients who need endodontic retreatment in anterior teeth, preparation of parallel radiographs of patients, and devising them randomly into two groups. In both groups, canal cleaning and shaping are done in the first session. For group 2, in the second session, after the final washing with distilled water, 940nm laser is used by Smile Doctor device with 200-micrometer fiber, continuously and 1.5watts. In each channel, 2 seconds of radiation will be done for every millimeter of channel length. Radiation is done twice in each channel. Fiber optic that if 1mm shorter than the working length will be used in the circumferential direction of the canal. The healing process of periapical lesions of patients will be followed up before, 3 and 6 months after treatment, and measured by parallel radiography and periapical index. After collecting data, it will be analyzed and statistically interpreted.
Participants/Inclusion and exclusion criteria
Entry: to 40-year-old, no medical history, periapical lesion in the radiograph, patient's consent Exit: illiterate patient, systemic disease, history of antibiotic use and hospitalization, a tooth that is periodontally and endodontically complex and incurable
Intervention groups
Intervention group: in the second session, after the final washing with distilled water, 940nm laser is used by Smile Doctor device with 200-micrometer fiber, continuously and 1.5watts. Control group: Routine root canal treatment
Main outcome variables
Laser power, periapical index, age, gender, root fracture/crack, root resorption , transportation, ledge, the apex of the root, sinus tract, periodontal pocket, tooth mobility, and overfilling

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220713055458N1
Registration date: 2022-08-27, 1401/06/05
Registration timing: registered_while_recruiting

Last update: 2022-08-27, 1401/06/05
Update count: 0
Registration date
2022-08-27, 1401/06/05
Registrant information
Name
Maryam Noferesti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3246 6257
Email address
maryam.noferesti824@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using a diode laser on the healing process of periapical lesions of teeth after endodontic retreatment: A controlled clinical trial study
Public title
Effect of laser in the healing of periapical lesions of teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient must be 18 to 40 years old The patient has no medical history Dental radiographic evidence shows a periapical lesion The patient must consent to participate in the study
Exclusion criteria:
The patient is illiterate The patient has a systemic disease The patient has a history of taking antibiotics The patient has a history of hospitalization The tooth has mobility more than no.1 Tooth has an open apex Tooth is non-restorable It is impossible to isolate the tooth The tooth has a pocket of more than 4 mm The tooth has a history of root canal treatment failure due to crack/fracture, resorption, perforation, ledge, overfilling, transportation
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is the lottery. We prepare 24 sealed envelopes that contain the type of root retreatment of the patient's tooth. 12 of the envelopes are retreatment with laser and 12 of the envelopes are retreatment without laser. These envelopes will be provided to the patient reception department in random order, and when the patient is admitted, an envelope will be randomly selected and the treatment method of the patient will be determined. The randomization unit is the patients. The randomization tool is a sealed envelope. Only the person who prepared the envelopes knows the contents of the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who participate in the study will only be informed that they will be randomly assigned to one of the groups of endodontic retreatment or endodontic retreatment with laser by receiving the consent form. For the analyzer, the control and intervention groups are not distinguishable.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Central Organization of Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2022-05-08, 1401/02/18
Ethics committee reference number
1401.036

Health conditions studied

1

Description of health condition studied
The healing of periapical lesions
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Periapical healing status
Timepoint
Before treatment, 3 months after treatment, and 6 months after treatment
Method of measurement
Using Qrstavik's periapical index (PAI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the second session of treatment, after the final washing with distilled water, a 940 nm laser is used. Laser radiation is performed by a smile doctor device with 200-micrometer fiber, continuously (CW) and 1.5 watts. In each channel, 2 seconds of radiation is done for each millimeter of channel length. Radiation is done twice in each channel. Fiber optic that if 1 mm shorter than the working length will be used in the circumferential direction of the canal.
Category
Treatment - Devices

2

Description
Control group: In the second session, calcium hydroxide is washed from the canals using 5 ml of 2.5% sodium hypochlorite and using a Hedstrom file corresponding to the MAF (Master Apical File).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Soheila Darmiani's office
Full name of responsible person
Dr. Soheila Darmiani
Street address
No 18, Abu Rihan Biruni St., Ghaffari Blv.
City
Birjand
Province
South Khorasan
Postal code
9717964658
Phone
+98 56 3204 8472
Email
Soheiladarmiani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Miri
Street address
No. 13, Pasdaran 66 Ave., Pasdaran Blv.
City
Birjand
Province
South Khorasan
Postal code
9717714713
Phone
+98 56 3246 2757
Email
maryam.noferesti824@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
1
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
Birjand University of Medical Sciences
Full name of responsible person
Maryam Noferesti
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.13, 66 Pasdaran Ave., Pasdaran Blv., Birjand Town
City
Birjand
Province
South Khorasan
Postal code
971771473
Phone
+98 56 3246 6257
Fax
Email
Maryam.noferesti824@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Soheila Darmiani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.18, Abu reyhan Ave., Ghaffari Blv., Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717964658
Phone
+98 56 3204 8472
Fax
Email
soheiladarmiani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Noferesti
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.13, 66 Pasdaran Ave., Pasdaran Blv., Birjand Town
City
Birjand
Province
South Khorasan
Postal code
971771473
Phone
+98 56 3246 6257
Fax
Email
Maryam.noferesti824@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
Undecided - It is not yet known if there will be a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Conclusion. Part of the information related to the main outcome of the study is shared.
When the data will become available and for how long
Access starts 6 months after results are published.
To whom data/document is available
General and specialist dentists, students, and researchers working in academic and scientific institutions.
Under which criteria data/document could be used
To carry out a research card and under the conditions that root canal treatment, surgery, and periodontology are supposed to be done.
From where data/document is obtainable
Refer to the scientific officer.
What processes are involved for a request to access data/document
During 9 months, data will be collected and then during the next 8 months, the data will be analyzed.
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