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

Not Applicable

Completed

• Conditions: Effects of the Elements
• Interventions: Drug: Triple antibiotic paste disinfection; Device: Diode Laser bio-stimulation.; Device: Diode laser disinfection; Procedure: revascularization using the standard method "Blood Clot"

• Registration Number: NCT05445362
• Lead Sponsor: Reham Hassan

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

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-08-30
• Study Completion: 2021-02-26
• Study First Submitted: 2022-06-26
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group III	revascularization using the standard method "Blood Clot"	Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.
Group I	Triple antibiotic paste disinfection	Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method.
Group II	revascularization using the standard method "Blood Clot"	Thirteen teeth were Laser disinfected; revascularization was done using the standard method.
Group III	Diode Laser bio-stimulation.	Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.
Group I	revascularization using the standard method "Blood Clot"	Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method.
Group II	Diode laser disinfection	Thirteen teeth were Laser disinfected; revascularization was done using the standard method.
Group III	Triple antibiotic paste disinfection	Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.

Primary Outcome Measures

Name	Time	Method
The change in root length evaluation	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

Secondary Outcome Measures

Name	Time	Method
The change in root thickness	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
The change in apical diameter	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

Trial Locations

Locations (1)

Faculty of Oral and dental medicine, Minia University; 🇪🇬 Minya, Egypt