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Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps

Primary Purpose

Effects of the Elements

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Diode laser disinfection
Diode Laser bio-stimulation.
Triple antibiotic paste disinfection
revascularization using the standard method "Blood Clot"
Sponsored by
Reham Hassan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effects of the Elements focused on measuring Diode Laser, Revascularization, Immature Necrotic Teeth.

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Oral and dental medicine, Minia University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Group III

Arm Description

Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method.

Thirteen teeth were Laser disinfected; revascularization was done using the standard method.

Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The change in root thickness
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
The change in apical diameter
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

Full Information

First Posted
June 26, 2022
Last Updated
August 22, 2022
Sponsor
Reham Hassan
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1. Study Identification

Unique Protocol Identification Number
NCT05445362
Brief Title
Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps
Official Title
Evaluation of the Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps: A Preliminary Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
February 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Reham Hassan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of the Elements
Keywords
Diode Laser, Revascularization, Immature Necrotic Teeth.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Thirteen teeth were Laser disinfected; revascularization was done using the standard method.
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.
Intervention Type
Device
Intervention Name(s)
Diode laser disinfection
Intervention Description
- 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.
Intervention Type
Device
Intervention Name(s)
Diode Laser bio-stimulation.
Intervention Description
- 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.
Intervention Type
Drug
Intervention Name(s)
Triple antibiotic paste disinfection
Intervention Description
-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) .
Intervention Type
Procedure
Intervention Name(s)
revascularization using the standard method "Blood Clot"
Other Intervention Name(s)
Blood Clot revascularization method
Intervention Description
- 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 .
Primary Outcome Measure Information:
Title
The change in root length evaluation
Description
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
Time Frame
at baseline, 3, 6, 9, and 12 months after treatment
Secondary Outcome Measure Information:
Title
The change in root thickness
Description
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
Time Frame
At base line , 3, 6, 9, and 12 month after treatment
Title
The change in apical diameter
Description
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
Time Frame
At base line, 3, 6, 9, and 12 month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham Hassan, Assoc, prof
Organizational Affiliation
Minia University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Oral and dental medicine, Minia University
City
Minya
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps

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