- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05445362
Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps
Evaluation of the Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps: A Preliminary Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
- The investigator recruited patients who are found eligible to the criteria then randomly allocated into three groups (n=13)
- Group I: thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the blood clot method.
- Group II: thirteen teeth were Laser disinfected; revascularization was done using the the blood clot method.
- Group III: thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the the blood clot method followed by diode laser bio-stimulation.
- periapical x rays was taken at baseline, 3, 6, 9, and 12 months after treatment for the increase in root length and thickness, decrease in apical diameter evaluation
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Minya, Egypt
- Faculty of Oral and dental medicine, Minia University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medically free patients.
- Immature permanent maxillary anterior teeth.
- Non vital pulp.
- patents age between 8-16 years.
- Both sexes.
- Restorable teeth.
- No internal or external root resorption.
- No horizontal or vertical root fracture
- Radiographic periapical radiolucency
- No history of previous endodontic treatment of the tooth.
Exclusion Criteria:
- Medically compromised patients
- Previous endodontic therapy of the affected tooth.
- Teeth diagnosed with vital pulp.
- Teeth with periodontal pocket more than 3mm deep.
- Teeth with caries below the bony level (non-restorable tooth).
- Mature teeth with complete apices.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group I
Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method.
|
-The root canals will be copiously and slowly irrigated with 20 ml of 1.5% (17) sodium hypochlorite (NaOCl) solution for 5 minutes alternatively with 20 ml of 17% ethylene diamine tetra acetic acid (E.D.T.A) solution for 5 minutes with intermediated rinse of distilled water with paper point dryness in between irrigations.
The triple antibiotic paste will be prepared using metronidazole , ciprofloxacin and doxycycline .
The doxycycline capsule content will be evacuated in a sterile mortar; a tablet of metronidazole and a tablet of ciprofloxacin will be crushed and ground into homogenous powder in the same mortar using a pestle.
Saline drops will be added and mixed using the pestle until a creamy paste achieved .
The canals Will be dried with paper points and medicated with triple antibiotic paste; the access cavity will be sealed with intermediate restorative material (I.R.M) .
- The root canal Will be over-instrumented using finger plugger size #25 to encourage bleeding up to cemento-enamel junction.
The sterile finger plugger size # 25 will be used with sharp strokes into the periapical tissue beyond the apex until bleeding becomes evident at the cervical portion of the canal.
Blood column will be left 10 minutes to clot covered by sterile cotton, a collagen orifice plug "Collagen plugs" will be used as matrix against mineral trioxide aggregate (M.T.A) condensation, M.T.A will be mixed according to the manufacturer's instructions and carried to the cavity with M.T.A carrier (Dovgan M.T.A Carrier) , and then compacted using wet cotton roll on pluggers (S- Kondenser) .
Finally the cavity will be restored with a glass ionomer base and light cure composite resin .
Other Names:
|
Active Comparator: Group II
Thirteen teeth were Laser disinfected; revascularization was done using the standard method.
|
- The root canal Will be over-instrumented using finger plugger size #25 to encourage bleeding up to cemento-enamel junction.
The sterile finger plugger size # 25 will be used with sharp strokes into the periapical tissue beyond the apex until bleeding becomes evident at the cervical portion of the canal.
Blood column will be left 10 minutes to clot covered by sterile cotton, a collagen orifice plug "Collagen plugs" will be used as matrix against mineral trioxide aggregate (M.T.A) condensation, M.T.A will be mixed according to the manufacturer's instructions and carried to the cavity with M.T.A carrier (Dovgan M.T.A Carrier) , and then compacted using wet cotton roll on pluggers (S- Kondenser) .
Finally the cavity will be restored with a glass ionomer base and light cure composite resin .
Other Names:
- Disinfection with parameter of Power: 1.5 watt, Mode: pulse: SP: Ton=10ms; Toff10ms 50Hz (50% pulse mode), for 5 seconds in spiral movement in apical to coronal direction no stop with non-initiated endodontic tip 200 micron diameter and 15 mm length three times.
Irrigation with NaOCl, irradiation with the laser, then irrigation with E.D.T.A and irradiation with the laser, for three times then final rinse with distilled water with paper point dryness in between irrigations.
|
Active Comparator: Group III
Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.
|
-The root canals will be copiously and slowly irrigated with 20 ml of 1.5% (17) sodium hypochlorite (NaOCl) solution for 5 minutes alternatively with 20 ml of 17% ethylene diamine tetra acetic acid (E.D.T.A) solution for 5 minutes with intermediated rinse of distilled water with paper point dryness in between irrigations.
The triple antibiotic paste will be prepared using metronidazole , ciprofloxacin and doxycycline .
The doxycycline capsule content will be evacuated in a sterile mortar; a tablet of metronidazole and a tablet of ciprofloxacin will be crushed and ground into homogenous powder in the same mortar using a pestle.
Saline drops will be added and mixed using the pestle until a creamy paste achieved .
The canals Will be dried with paper points and medicated with triple antibiotic paste; the access cavity will be sealed with intermediate restorative material (I.R.M) .
- The root canal Will be over-instrumented using finger plugger size #25 to encourage bleeding up to cemento-enamel junction.
The sterile finger plugger size # 25 will be used with sharp strokes into the periapical tissue beyond the apex until bleeding becomes evident at the cervical portion of the canal.
Blood column will be left 10 minutes to clot covered by sterile cotton, a collagen orifice plug "Collagen plugs" will be used as matrix against mineral trioxide aggregate (M.T.A) condensation, M.T.A will be mixed according to the manufacturer's instructions and carried to the cavity with M.T.A carrier (Dovgan M.T.A Carrier) , and then compacted using wet cotton roll on pluggers (S- Kondenser) .
Finally the cavity will be restored with a glass ionomer base and light cure composite resin .
Other Names:
- The diode laser bio-stimulation with Wiser Diode Laser, Irradiation of the periapical area from the labial mucosal surface, day after day "day on-day off" for one week, two sessions will be applied at the same day with two hours interval, first session immediately after filing (blood induction), with flat top hand piece , diameter 1cm at a distance between 0 and 105 cm, at 1 watt power for 50s with CW "continues mode" in order to obtain the 5 J/cm2 fluence.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in root length evaluation
Time Frame: at baseline, 3, 6, 9, and 12 months after treatment
|
Numerical using Image-J analysis software for radiographs standardization and measuring in mm, the percentage of change in length will be calculated by subtracting the 12 m length from the baseline , 3, 6, 9 months lengths divided by the baseline, 3, 6, 9 months length multiplying the value by 100 - post length - pre length / pre length x 100 |
at baseline, 3, 6, 9, and 12 months after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in root thickness
Time Frame: At base line , 3, 6, 9, and 12 month after treatment
|
Measurements in mmm using Image-J analysis software for radiographs standardization and measuring, the percentage of change in root width will be calculated by subtracting the 12 m length from the baseline , 3, 6, 9 months lengths divided by the baseline, 3, 6, 9 months widths multiplying the value by 100
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At base line , 3, 6, 9, and 12 month after treatment
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The change in apical diameter
Time Frame: At base line, 3, 6, 9, and 12 month after treatment
|
Measurements in mmm using Image-J analysis software for radiographs standardization and measuring, the percentage of apical diameter size change will be calculated as follows - pre diameter - post diameter / pre diameter X 100 , to get the percentage of apical diameter change with the deferent time changes "baseline, 3, 6, 9, and 12 months |
At base line, 3, 6, 9, and 12 month after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Reham Hassan, Assoc, prof, Minia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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