Pulp Disease, DentalPhase 4NCT06002646
Lasers as an Alternative to Formocresol and Sodium Hypochlorite Medicaments in Pulpotomy Techniques
A Phase 4 study testing Formocresol, Sodium Hypochlorite Solution and Diode laser in people with Pulp Disease, Dental and Pulp Mummification, run by University of Sulaimani at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to evaluate the dental lasers as an alternative of chemical medicaments used in the pulpotomy procedures. The main question it aims to answer is: Lasers pulpotomies are a viable alternative to the standard Formocresol and Sodium Hypochlorite medicaments. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Pulp Disease, Dental, Pulp Mummification
- What is being tested?
- Formocresol, Sodium Hypochlorite Solution and Diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 4 Jan 2023to 4 Apr 2024
- Phase
- Phase 4
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Deep carious lesions present in primary molars.
- No history of spontaneous or persistent pain.
- Lack of clinical evidence of pulpal degeneration, such as pain on percussion, history of swelling or sinus tracts.
- Restorable teeth following completion of the procedure.
- Absence of radiographic signs and symptoms of pulpal degeneration.
- Following pulpal amputation, hemostasis could be easily achievable.
Who cannot join
- Uncooperative children.
- Children with medically compromised disease.
- Presence of radiographical signs and symptoms of pulpal degeneration.
- Physiologic root resorption is more than one-third.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Diode and Er:Cr;YSGG Lasers as an Alternative to Formocresol and Sodium Hypochlorite for Pulpotomy Technique in Primary Molars - Randomized Controlled Clinical Trial
The goal of this clinical trial is to evaluate the dental lasers as an alternative of chemical medicaments used in the pulpotomy procedures. The main question it aims to answer is:
- Lasers pulpotomies are a viable alternative to the standard Formocresol and Sodium Hypochlorite medicaments.
All participants groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG lasers) for pulpotomy procedure will follow the same clinical protocol, except for the techniques that will be used for hemostasis of the pulpotomies which either will be achieved by Formocresol or Sodium Hypochlorite solutions or by Diode or Erbium lasers.
Read the detailed description
All the selected treatment groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG lasers) will follow the same clinical protocol, except for the techniques that will be used for hemostasis of the pulpotomies:
- Using 2 percent lidocaine with 1: 100,000 epinephrine as a local anesthetic.
- Isolation of the teeth with a rubber dam.
- Using a diamond round #440 bur in a high-speed hand piece with water cooling to eliminate caries and expose pulp chambers.
- Using a spoon excavator to remove the coronal pulp.
- Achieving the hemostasis by:
- In first group (Group A): using a 1:5 dilution of Buckley's FC solution. A sterile cotton pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the canal was infected, and the tooth will be removed from the research.
II. In the second group (Group B): using 3% NaOCl. A sterile cotton pellet will be moistened with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving hemostasis before being covered with MTA.
III. In the third group (Group C): In this group hemostasis will be achieved by exposure to diode laser of 940 nm. The laser energy will be introduced into the canal orifice through a 300 µm optical fiber at 2 W, in a contact mode with continuous mode CW (According to the user manual) for 1 second at each orifice for three times to achieve complete hemostasis. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.
IV. In the fourth group (Group D): Irradiation of the floor of the pulp chamber with Er,Cr:YSGG laser 2790 nm ) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode) , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.). In which a fixed char layer should be formed over the pulpal tissue of the canals orifices. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.
- Then covering the surface with a 2 mm layer of MTA
- The final restoration will be completed in all the four groups, stainless steel crown will be placed as the final restorative material with a well-fitting marginal adaption and glass ionomer cement(GC company).
- Conditions
- Pulp Disease, Dental, Pulp Mummification
- Being tested
- Formocresol, Sodium Hypochlorite Solution, Diode laser, Er,Cr:YSGG laser
- Medical subject headings
- Dental Pulp Diseases, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormocresolDrug
Also called Buckley's solution
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with Formocresol solution
Sodium Hypochlorite SolutionDrug
Also called NaOCl
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 3% Sodium Hypochlorite Solution.
Diode laserDevice
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 940 nm diode laser.
Er,Cr:YSGG laserDevice
Also called Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laser
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 2790nm Er,Cr:YSGG laser.
| Study group | Role | What they receive |
|---|---|---|
| first group (Group A) | Active comparator | using a 1:5 dilution of Buckley's FC (SSA, Produits Dentaires, Switzerland). A sterile cotton pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the canal was infected, and the tooth will be removed from the research Receives: Drug: Formocresol |
| second group (Group B) | Experimental | using 3% NaOCl(Tahno-dent, Greece) A sterile cotton pellet will be moistened with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving hemostasis before being covered with MTA Receives: Drug: Sodium Hypochlorite Solution |
| third group (Group C) | Experimental | In this group hemostasis will be achieved by exposure to diode laser (Biolase, epic X) of 940 nm. The laser energy will be introduced into the canal orifice through a 300 µm optical fiber at 2 W, in a contact mode with continuous mode CW(According to the user manual('EpicX_CAN_UM.pdf', no date) for 1 second at each orifice for three times to achieve complete hemostasis. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual. Receives: Device: Diode laser |
| fourth group (Group D) | Experimental | Irradiation of the floor of the pulp chamber with Er,Cr:YSGG laser 2790 nm (Waterlase MD, Biolase) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode) , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.)('WaterLase-iPlus-UM.pdf', no date). In which a fixed char layer should be formed over the pulpal tissue of the canals orifices. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual. Receives: Device: Er,Cr:YSGG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical and radiographical success rate of pulpotomy procedure of FC, and NaOCl techniques and two different types of lasers Diode and Erbium Cr,YSGG lasers
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start4 Jan 2023
- Primary completion8 Jun 2023
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulp Disease, DentalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wasan Adil, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002646
- Sponsor's protocol ID
- USaimani
- Other IDs
- Registration No.: 159/23
- Status last verified
- Apr 2024
- First submitted
- 1 Aug 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fadhil WA, Noori AJ. Clinical and Radiographic Evaluation of Diode and Er,Cr:YSGG Lasers as an Alternative to Formocresol and Sodium Hypochlorite for Pulpotomy Techniques in Primary Molars: A Randomized Controlled Clinical Trial. Cureus. 2024 Jul 31;16(7):e65902. doi: 10.7759/cureus.65902. eCollection 2024 Jul.
PubMed 39219956
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Diode and Er:Cr;YSGG Lasers as an Alternative to Formocresol and Sodium Hypochlorite for Pulpotomy Technique in Primary Molars - Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06002646
- Acronym / sponsor ID
- USaimani
- Conditions
- Pulp Disease, Dental, Pulp Mummification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 21 Aug 2023 (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.
The goal of this clinical trial is to evaluate the dental lasers as an alternative of chemical medicaments used in the pulpotomy procedures. The main question it aims to answer is:
- Lasers pulpotomies are a viable alternative to the standard Formocresol and Sodium Hypochlorite medicaments.
All participants groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG lasers) for pulpotomy procedure will follow the same clinical protocol, except for the techniques that will be used for hemostasis of the pulpotomies which either will be achieved by Formocresol or Sodium Hypochlorite solutions or by Diode or Erbium lasers.
Detailed description
All the selected treatment groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG lasers) will follow the same clinical protocol, except for the techniques that will be used for hemostasis of the pulpotomies:
- Using 2 percent lidocaine with 1: 100,000 epinephrine as a local anesthetic.
- Isolation of the teeth with a rubber dam.
- Using a diamond round #440 bur in a high-speed hand piece with water cooling to eliminate caries and expose pulp chambers.
- Using a spoon excavator to remove the coronal pulp.
- Achieving the hemostasis by:
- In first group (Group A): using a 1:5 dilution of Buckley's FC solution. A sterile cotton pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the canal was infected, and the tooth will be removed from the research.
II. In the second group (Group B): using 3% NaOCl. A sterile cotton pellet will be moistened with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving hemostasis before being covered with MTA.
III. In the third group (Group C): In this group hemostasis will be achieved by exposure to diode laser of 940 nm. The laser energy will be introduced into the canal orifice through a 300 µm optical fiber at 2 W, in a contact mode with continuous mode CW (According to the user manual) for 1 second at each orifice for three times to achieve complete hemostasis. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.
IV. In the fourth group (Group D): Irradiation of the floor of the pulp chamber with Er,Cr:YSGG laser 2790 nm ) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode) , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.). In which a fixed char layer should be formed over the pulpal tissue of the canals orifices. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.
- Then covering the surface with a 2 mm layer of MTA
- The final restoration will be completed in all the four groups, stainless steel crown will be placed as the final restorative material with a well-fitting marginal adaption and glass ionomer cement(GC company).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| first group (Group A) | Active comparator | Drug: Formocresolusing a 1:5 dilution of Buckley's FC (SSA, Produits Dentaires, Switzerland). A sterile cotton pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the canal was infected, and the tooth will be removed from the research |
| second group (Group B) | Experimental | Drug: Sodium Hypochlorite Solutionusing 3% NaOCl(Tahno-dent, Greece) A sterile cotton pellet will be moistened with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving hemostasis before being covered with MTA |
| third group (Group C) | Experimental | Device: Diode laserIn this group hemostasis will be achieved by exposure to diode laser (Biolase, epic X) of 940 nm. The laser energy will be introduced into the canal orifice through a 300 µm optical fiber at 2 W, in a contact mode with continuous mode CW(According to the user manual('EpicX_CAN_UM.pdf', no date) for 1 second at each orifice for three times to achieve complete hemostasis. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual. |
| fourth group (Group D) | Experimental | Device: Er,Cr:YSGG laserIrradiation of the floor of the pulp chamber with Er,Cr:YSGG laser 2790 nm (Waterlase MD, Biolase) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode) , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.)('WaterLase-iPlus-UM.pdf', no date). In which a fixed char layer should be formed over the pulpal tissue of the canals orifices. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Deep carious lesions present in primary molars.
- No history of spontaneous or persistent pain.
- Lack of clinical evidence of pulpal degeneration, such as pain on percussion, history of swelling or sinus tracts.
- Restorable teeth following completion of the procedure.
- Absence of radiographic signs and symptoms of pulpal degeneration.
Key exclusion criteria (4 listed)
- Uncooperative children.
- Children with medically compromised disease.
- Presence of radiographical signs and symptoms of pulpal degeneration.
- Physiologic root resorption is more than one-third.
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 |
|---|---|---|
| FormocresolAlso: Buckley's solutionHemostasis of pulpal tissue in primary teeth pulpotomy techniques with Formocresol solution | Drug | first group (Group A) |
| Sodium Hypochlorite SolutionAlso: NaOClHemostasis of pulpal tissue in primary teeth pulpotomy techniques with 3% Sodium Hypochlorite Solution. | Drug | second group (Group B) |
| Diode laserHemostasis of pulpal tissue in primary teeth pulpotomy techniques with 940 nm diode laser. | Device | third group (Group C) |
| Er,Cr:YSGG laserAlso: Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laserHemostasis of pulpal tissue in primary teeth pulpotomy techniques with 2790nm Er,Cr:YSGG laser. | Device | fourth group (Group D) |
Primary outcome
Evaluation of clinical and radiographical success rate of pulpotomy procedure of FC, and NaOCl techniques and two different types of lasers Diode and Erbium Cr,YSGG lasers
Time frame: one year
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 19 Apr 2024.
- Derived from this study: PubMed 39219956Fadhil WA, Noori AJ. Clinical and Radiographic Evaluation of Diode and Er,Cr:YSGG Lasers as an Alternative to Formocresol and Sodium Hypochlorite for Pulpotomy Techniques in Primary Molars: A Randomized Controlled Clinical Trial. Cureus. 2024 Jul 31;16(7):e65902. doi: 10.7759/cureus.65902. eCollection 2024 Jul.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Formocresol, Sodium Hypochlorite Solution and Diode laser in people with Pulp Disease, Dental and Pulp Mummification, run by University of Sulaimani at 1 site in Iraq.
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 6 inclusion and 4 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 19 Apr 2024. 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 Iraq. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of clinical and radiographical success rate of pulpotomy procedure of FC, and NaOCl techniques and two different types of lasers Diode and Erbium Cr,YSGG lasers (time frame: one year). 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 NCT06002646, which also lists 1 linked publication.
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 19 Apr 2024.