Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Registration No.: 159/23 | Other Identifier | College of Dentistry/ University of Sulaimani |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
I. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formocresol | Drug | Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with Formocresol solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wasan Adil Fadhil | Sulaymaniyah | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39219956 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| C031025 | formocresol |
| D012973 | Sodium Hypochlorite |
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized double blinded clinical trial in which both the participants(patients) and the investigator don't know about which type of treatment groups will be applied.
|
| Sodium Hypochlorite Solution | Drug | Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 3% Sodium Hypochlorite Solution. |
|
|
| Diode laser | Device | Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 940 nm diode laser. |
|
| Er,Cr:YSGG laser | Device | Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 2790nm Er,Cr:YSGG laser. |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017601 |
| Oxygen Compounds |
| D017670 | Sodium Compounds |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |