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

NCT ID: NCT05445362

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-02-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Effects of the Elements

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I

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

Group Type ACTIVE_COMPARATOR

Triple antibiotic paste disinfection

Intervention Type DRUG

-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) .

revascularization using the standard method "Blood Clot"

Intervention Type PROCEDURE

\- 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 .

Group II

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

Group Type ACTIVE_COMPARATOR

Diode laser disinfection

Intervention Type DEVICE

\- 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.

revascularization using the standard method "Blood Clot"

Intervention Type PROCEDURE

\- 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 .

Group III

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

Group Type ACTIVE_COMPARATOR

Diode Laser bio-stimulation.

Intervention Type DEVICE

\- 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.

Triple antibiotic paste disinfection

Intervention Type DRUG

-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) .

revascularization using the standard method "Blood Clot"

Intervention Type PROCEDURE

\- 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 .

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diode laser disinfection

\- 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

Diode Laser bio-stimulation.

\- 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 DEVICE

Triple antibiotic paste disinfection

-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 DRUG

revascularization using the standard method "Blood Clot"

\- 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 .

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Blood Clot revascularization method

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Reham Hassan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Reham Hassan

Assoc. Prof. Dr Reham Hassan

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Reham Hassan, Assoc, prof

Role: STUDY_DIRECTOR

Minia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Oral and dental medicine, Minia University

Minya, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

145

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.