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
1 other identifier
interventional
39
1 country
1
Brief Summary
Recruited patients with immature permanent maxillary anterior teeth with non-vital pulp, and periapical radiolucency, age ranging from 8 to16 years old were randomly allocated into three groups (n=13): Group I, disinfected using the triple antibiotic paste, Group II, disinfection was done using diode laser, and Group III, were disinfected using the triple antibiotic paste, diode laser was used for biostimulation. All groups were evaluated for the increase in root length and thickness and decrease in apical diameter at baseline, 3, 6, 9, and 12 months after treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2021
CompletedFirst Submitted
Initial submission to the registry
June 26, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedAugust 25, 2022
August 1, 2022
1.6 years
June 26, 2022
August 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in root length evaluation
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
Secondary Outcomes (2)
The change in root thickness
At base line , 3, 6, 9, and 12 month after treatment
The change in apical diameter
At base line, 3, 6, 9, and 12 month after treatment
Study Arms (3)
Group I
ACTIVE COMPARATORThirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method.
Group II
ACTIVE COMPARATORThirteen teeth were Laser disinfected; revascularization was done using the standard method.
Group III
ACTIVE COMPARATORThirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.
Interventions
\- 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.
\- 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.
-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 .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Reham Hassanlead
Study Sites (1)
Faculty of Oral and dental medicine, Minia University
Minya, Egypt
Study Officials
- STUDY DIRECTOR
Reham Hassan, Assoc, prof
Minia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assoc. Prof. Dr Reham Hassan
Study Record Dates
First Submitted
June 26, 2022
First Posted
July 6, 2022
Study Start
February 1, 2019
Primary Completion
August 30, 2020
Study Completion
February 26, 2021
Last Updated
August 25, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF