Effects of the ElementsNCT05445362

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

A study testing Diode laser disinfection, Diode Laser bio-stimulation. and Triple antibiotic paste disinfection in people with Effects of the Elements, run by Reham Hassan at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 8 to 16 yearsHealthy volunteers can take part
Conditions the study is for: Effects of the Elements
What is being tested?: Diode laser disinfection, Diode Laser bio-stimulation. and Triple antibiotic paste disinfection
Type of treatment: Pill or oral medicine, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteEgypt
Study dates: 1 Feb 2019to 26 Feb 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 16 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Medically free patients.
Immature permanent maxillary anterior teeth.
Non vital pulp.
patents age between 8-16 years.
Both sexes.
Restorable teeth.

Show all 10Show fewer

No internal or external root resorption.
No horizontal or vertical root fracture
Radiographic periapical radiolucency
No history of previous endodontic treatment of the tooth.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Oral and dental medicine, Minia University
Minya

Other trials in Egypt

About this study

Official title: Evaluation of the Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps: A Preliminary Randomized Controlled Trial

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

Read the 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

Conditions: Effects of the Elements
Being tested: Diode laser disinfection, Diode Laser bio-stimulation., Triple antibiotic paste disinfection, revascularization using the standard method "Blood Clot"
Keywords: Diode Laser, Revascularization, Immature Necrotic Teeth.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diode laser disinfectionDevice
- 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.
Diode Laser bio-stimulation.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 disinfectionDrug
-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"Procedure or surgery
Also called Blood Clot revascularization 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 .

Study groups in NCT05445362
Study group	Role	What they receive
Group I	Active comparator	Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method. Receives: Drug: Triple antibiotic paste disinfection; Procedure: revascularization using the standard method "Blood Clot"
Group II	Active comparator	Thirteen teeth were Laser disinfected; revascularization was done using the standard method. Receives: Device: Diode laser disinfection; Procedure: revascularization using the standard method "Blood Clot"
Group III	Active comparator	Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation. Receives: Device: Diode Laser bio-stimulation.; Drug: Triple antibiotic paste disinfection; Procedure: revascularization using the standard method "Blood Clot"

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: at baseline, 3, 6, 9, and 12 months after treatment

Secondary outcomes (2)

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
Measured: At base line , 3, 6, 9, and 12 month after treatment
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
Measured: At base line, 3, 6, 9, and 12 month after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201926 Feb 2021

First posted6 Jul 2022
Study start1 Feb 2019
Primary completion30 Aug 2020
Study completion26 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Effects of the ElementsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05445362
Sponsor's protocol ID: 145
Status last verified: Aug 2022
First submitted: 26 Jun 2022
Last updated: 25 Aug 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps: A Preliminary Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05445362
Acronym / sponsor ID: 145
Conditions: Effects of the Elements
Keywords: Diode Laser, Revascularization, Immature Necrotic Teeth.
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Reham HassanUniversity, hospital or other
Study start: 1 Feb 2019 (actual)
Primary completion: 30 Aug 2020 (actual)
Study completion: 26 Feb 2021 (actual)
First posted: 6 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group I	Active comparator	Drug: Triple antibiotic paste disinfection, Procedure: 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	Active comparator	Device: Diode laser disinfection, Procedure: revascularization using the standard method "Blood Clot"Thirteen teeth were Laser disinfected; revascularization was done using the standard method.
Group III	Active comparator	Device: Diode Laser bio-stimulation., Drug: Triple antibiotic paste disinfection, Procedure: 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.

Who may qualify

Ages: 8 to 16 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (10 listed)

Medically free patients.
Immature permanent maxillary anterior teeth.
Non vital pulp.
patents age between 8-16 years.
Both sexes.

Key exclusion criteria (6 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Group II
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.	Device	Group III
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) .	Drug	Group I, Group III
revascularization using the standard method "Blood Clot"Also: Blood Clot revascularization 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 .	Procedure or surgery	Group I, Group II, Group III

Primary outcome

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

2 secondary outcomes

The change in root thickness
Time frame: At base line , 3, 6, 9, and 12 month after treatment
The change in apical diameter
Time frame: At base line, 3, 6, 9, and 12 month after treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
Individual participant dataSharing planned: Yes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Reham Hassan, Assoc, prof study director

Minia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Diode laser disinfection, Diode Laser bio-stimulation. and Triple antibiotic paste disinfection in people with Effects of the Elements, run by Reham Hassan at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in root length evaluation (time frame: at baseline, 3, 6, 9, and 12 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05445362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.