MTA Vital Tooth PulpotomyNCT06711081
Clinical & Radiographic Efficacy Using LLLT & CRYO on M.P.M Pulpotomy
A study testing low level laser device cryotherapy in people with MTA Vital Tooth Pulpotomy, run by Tanta University at 1 site in Egypt.
Trial summary
This in-vivo study aims to evaluate the efficacy of the low level laser therapy and cryotherapy in treatment of vital pulpotomy in mature permanent molar evaluating the post operative pain and the radiographic changes in pulpal and periodontal regions. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- MTA Vital Tooth Pulpotomy
- What is being tested?
- low level laser device cryotherapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Restorable vital and mature mandibular molar teeth with irreversible pulpitis.
- Teeth with deep caries or large restoration.
- Pre-operative radiograph showing normal periapical structure.
- Teeth with normal periodontal status .
Who cannot join
- • Medically compromised patients with active systemic disease as uncontrolled diabetes mellitus, hypertension or cardiac diseases.
- Teeth with periapical lesion.
- Sinus tract or swelling.
- Moderate or severe marginal periodontitis.
- Patient allergic to any material or medication used in this study.
- Teeth with moderate to severe mobility.
- Teeth with periodontal diseases.
- Teeth with anatomical variations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Radiographic Evaluation Following Complete Pulpotomy Using Low Level LASER Therapy and Cryotherapy
This in-vivo study aims to evaluate the efficacy of the low level laser therapy and cryotherapy in treatment of vital pulpotomy in mature permanent molar evaluating the post operative pain and the radiographic changes in pulpal and periodontal regions.
Read the detailed description
Recently, there is a new direction of vital pulp therapy (VPT) that aims to preserve the tooth vitality and the root dentin and improves the long term prognosis of the tooth function. VPT is a personalized method of treating irreversible pulpitis which conforms to the trend of minimally invasive endodontics. There are many modalities of VPT like direct pulp capping, indirect pulp capping, pulpotomy and revascularization. Pulpotomy is defined as clinical procedure of removal of the coronal pulp tissue leaving the vital radicular pulp tissue as in cases of pulp exposure due to caries, trauma or iatrogenic error. Pulpotomy may be complete or partial according to the degree of extension of pulpal inflammation.
VPT depends on the theory that the pulp has the capacity of self-healing when it is free from infection. In addition, recent innovations of dental materials and techniques have been administrated to the field of endodontics have ensured higher success rate of VPT. Pulpotomy procedure has been introduced as an alternative to traditional root canal treatment in case of mature permanent teeth exhibiting symptoms of irreversible pulpitis when the radicular pulp is still vital.
There are many materials and techniques used for pulpotomy where the selection of the material used for this technique greatly influences its success rate. An ideal material for VPT must be biocompatible, antibacterial, providing biological and bacterial tight seal and promoting the regeneration of dentine-pulp complex. Calcium hydroxide (Ca(OH)2) and mineral trioxide aggregate (MTA) are considered the most commonly used materials for pulpotomy. However, Ca(OH)2 has many drawbacks as degradation over time, formation of tunnel defects beneath dentinal bridges and poor sealing ability, so it has lost its popularity as a first choice agent for pulpotomy. On the other hand, MTA has better sealing ability, biocompatibility and strength. However, it has some drawbacks like difficult handling, long setting time and discoloration of the tooth.
More recent pulpotomy materials have been introduced as putty bioceramic materials including: calcium silicate, monobasic calcium phosphate, zirconium oxide, tantalum oxide, and filler agents. They show better handling due to its premixed putty consistency in addition to its low level of tooth discoloration and rapid setting time compared to MTA.
In addition to the new materials, there are modifications of pulpotomy techniques which has been administrated to enhance its outcome as light amplification of estimated emission of radiation (LASER) and cryotherapy. The application of laser may enhance the outcomes of pulpotomy due to its ability to vaporize water in dental hard tissue so dentinal tubules will be opened and smear layer will be removed which in turn will increase the sealing ability of pulpotomy material.
One of the special forms of laser application is called low level laser therapy (LLLT) which can act as photoactivator on the pulp tissue cells by photostimulation without heat formation to enhance the cell differentiation and dentinogensis stimulation to promote tissue healing. In addition, it shows comparable effect to non-steroidal anti-inflammatory drugs (NASIDS), so it can be considered as an alternative to pain control through reduction of the exudative phase of inflammatory process, increasing synthesis of endorphins, decreasing bradykinin and altering pain threshold. On the other hand, the main disadvantages of laser include its uncontrolled depth of penetration through the tissue in addition to high cost of the laser device.
Moreover, Cryotherapy is another modified technique for pulpotomy. It is a procedure used to destroy tissue by freezing or re-thawing process through decreasing the temperature of the tissue. It has several physiological responses as decreasing of the local blood flow which can affect the homeostasis, temporary inhibition of the neural receptors in the pulp and decreasing of metabolic activity which in turn may affect the post-operative pain.
Cone beam computed tomography (CBCT) can be used for determination of periapical-periodontal status as it provides three dimensional demonstrations of the anatomic features plus accurate dimensional readings of the periapical tissue. The success of pulpotomy can be evaluated through the periapical-periodontal status radiographically which is confirmed clinically by absence of signs and symptoms.
Post-operative pain after pulpotomy is common. It is a noxious feeling after doing the procedure which may start immediately or later. Effective management of the post-operative pain is important in reducing the recovery time and improving patient outcomes
- Conditions
- MTA Vital Tooth Pulpotomy
- Being tested
- low level laser device cryotherapy
- Keywords
- vital pulp therapy permanent teeth pulpotomy LLLT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser device cryotherapyDevice
Also called cryotherapy
using new device direct on the pulp tissue
| Study group | Role | What they receive |
|---|---|---|
| • Group I: Conventional complete Pulpotomy using MTA (control group). | No intervention | MTA putty material will be placed using premixed capsule which will be triturated according to manufacturer's instructions. MTA will be placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed to the canal orifice using a condenser, then it will be covered by moistened cotton pellet for 2 minutes to achieve the initial setting, then the cotton pellet will be removed. A layer of resin modified glass ionomer cement will be placed and the tooth will be restored using light cured composite filling material . |
| • Group II: LLLT following complete pulpotomy. | Active comparator | after achieving homeostasis, LLLT will be applied using diode laser of 810 nm wave length with energy of 2 J/cm2 under a continuous mode with power output of 100 mW for about 10 sec with laser tip size 600 μm and 2 mm away from the canal orifice, Then MTA will be placed and the tooth will be restored as in group I. Receives: Device: low level laser device cryotherapy |
| • Group III: Cryotherapy following complete pulpotomy. | Active comparator | after achievement of homeostasis, the cryotherapy will be applied using small piece of shaved sterile ice wrapped with sterile piece of gauze (0° Celsius) which will be placed over the pulpal tissue in the pulp chamber. After approximately 60 seconds, the molten ice will be removed, then MTA will be placed and the tooth will be restored as in group I. Receives: Device: low level laser device cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic changes
and x-ray change either pulpal or periapical using CBCT subtraction
Measured: one year after treatment
Secondary outcomes (1)
Post operative pain
Post operative pain using visual analog scale by the patient description pain on his own words
Measured: one week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MTA Vital Tooth PulpotomyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Model description
- Assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed motiea mohamed morsy, Tanta University
- Investigators
- abeer darrag, phd, Principal investigator, Professor of Endodonticstokka moukhatar, Study director, Lecturer of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711081
- Sponsor's protocol ID
- LLLT& CRYO pulpotomy on M.P.M
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murray PE. Review of guidance for the selection of regenerative endodontics, apexogenesis, apexification, pulpotomy, and other endodontic treatments for immature permanent teeth. Int Endod J. 2023 Mar;56 Suppl 2:188-199. doi: 10.1111/iej.13809. Epub 2022 Aug 15.
PubMed 35929348Duncan HF, El-Karim I, Dummer PMH, Whitworth J, Nagendrababu V. Factors that influence the outcome of pulpotomy in permanent teeth. Int Endod J. 2023 Mar;56 Suppl 2:62-81. doi: 10.1111/iej.13866. Epub 2022 Nov 22.
PubMed 36334098
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation Following Complete Pulpotomy Using Low Level LASER Therapy and Cryotherapy
- ClinicalTrials.gov ID
- NCT06711081
- Acronym / sponsor ID
- LLLT& CRYO pulpotomy on M.P.M
- Conditions
- MTA Vital Tooth Pulpotomy
- Keywords
- vital pulp therapy permanent teeth pulpotomy LLLT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 2 Dec 2024 (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.
This in-vivo study aims to evaluate the efficacy of the low level laser therapy and cryotherapy in treatment of vital pulpotomy in mature permanent molar evaluating the post operative pain and the radiographic changes in pulpal and periodontal regions.
Detailed description
Recently, there is a new direction of vital pulp therapy (VPT) that aims to preserve the tooth vitality and the root dentin and improves the long term prognosis of the tooth function. VPT is a personalized method of treating irreversible pulpitis which conforms to the trend of minimally invasive endodontics. There are many modalities of VPT like direct pulp capping, indirect pulp capping, pulpotomy and revascularization. Pulpotomy is defined as clinical procedure of removal of the coronal pulp tissue leaving the vital radicular pulp tissue as in cases of pulp exposure due to caries, trauma or iatrogenic error. Pulpotomy may be complete or partial according to the degree of extension of pulpal inflammation.
VPT depends on the theory that the pulp has the capacity of self-healing when it is free from infection. In addition, recent innovations of dental materials and techniques have been administrated to the field of endodontics have ensured higher success rate of VPT. Pulpotomy procedure has been introduced as an alternative to traditional root canal treatment in case of mature permanent teeth exhibiting symptoms of irreversible pulpitis when the radicular pulp is still vital.
There are many materials and techniques used for pulpotomy where the selection of the material used for this technique greatly influences its success rate. An ideal material for VPT must be biocompatible, antibacterial, providing biological and bacterial tight seal and promoting the regeneration of dentine-pulp complex. Calcium hydroxide (Ca(OH)2) and mineral trioxide aggregate (MTA) are considered the most commonly used materials for pulpotomy. However, Ca(OH)2 has many drawbacks as degradation over time, formation of tunnel defects beneath dentinal bridges and poor sealing ability, so it has lost its popularity as a first choice agent for pulpotomy. On the other hand, MTA has better sealing ability, biocompatibility and strength. However, it has some drawbacks like difficult handling, long setting time and discoloration of the tooth.
More recent pulpotomy materials have been introduced as putty bioceramic materials including: calcium silicate, monobasic calcium phosphate, zirconium oxide, tantalum oxide, and filler agents. They show better handling due to its premixed putty consistency in addition to its low level of tooth discoloration and rapid setting time compared to MTA.
In addition to the new materials, there are modifications of pulpotomy techniques which has been administrated to enhance its outcome as light amplification of estimated emission of radiation (LASER) and cryotherapy. The application of laser may enhance the outcomes of pulpotomy due to its ability to vaporize water in dental hard tissue so dentinal tubules will be opened and smear layer will be removed which in turn will increase the sealing ability of pulpotomy material.
One of the special forms of laser application is called low level laser therapy (LLLT) which can act as photoactivator on the pulp tissue cells by photostimulation without heat formation to enhance the cell differentiation and dentinogensis stimulation to promote tissue healing. In addition, it shows comparable effect to non-steroidal anti-inflammatory drugs (NASIDS), so it can be considered as an alternative to pain control through reduction of the exudative phase of inflammatory process, increasing synthesis of endorphins, decreasing bradykinin and altering pain threshold. On the other hand, the main disadvantages of laser include its uncontrolled depth of penetration through the tissue in addition to high cost of the laser device.
Moreover, Cryotherapy is another modified technique for pulpotomy. It is a procedure used to destroy tissue by freezing or re-thawing process through decreasing the temperature of the tissue. It has several physiological responses as decreasing of the local blood flow which can affect the homeostasis, temporary inhibition of the neural receptors in the pulp and decreasing of metabolic activity which in turn may affect the post-operative pain.
Cone beam computed tomography (CBCT) can be used for determination of periapical-periodontal status as it provides three dimensional demonstrations of the anatomic features plus accurate dimensional readings of the periapical tissue. The success of pulpotomy can be evaluated through the periapical-periodontal status radiographically which is confirmed clinically by absence of signs and symptoms.
Post-operative pain after pulpotomy is common. It is a noxious feeling after doing the procedure which may start immediately or later. Effective management of the post-operative pain is important in reducing the recovery time and improving patient outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| • Group I: Conventional complete Pulpotomy using MTA (control group). | No intervention | –MTA putty material will be placed using premixed capsule which will be triturated according to manufacturer's instructions. MTA will be placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed to the canal orifice using a condenser, then it will be covered by moistened cotton pellet for 2 minutes to achieve the initial setting, then the cotton pellet will be removed. A layer of resin modified glass ionomer cement will be placed and the tooth will be restored using light cured composite filling material . |
| • Group II: LLLT following complete pulpotomy. | Active comparator | Device: low level laser device cryotherapyafter achieving homeostasis, LLLT will be applied using diode laser of 810 nm wave length with energy of 2 J/cm2 under a continuous mode with power output of 100 mW for about 10 sec with laser tip size 600 μm and 2 mm away from the canal orifice, Then MTA will be placed and the tooth will be restored as in group I. |
| • Group III: Cryotherapy following complete pulpotomy. | Active comparator | Device: low level laser device cryotherapyafter achievement of homeostasis, the cryotherapy will be applied using small piece of shaved sterile ice wrapped with sterile piece of gauze (0° Celsius) which will be placed over the pulpal tissue in the pulp chamber. After approximately 60 seconds, the molten ice will be removed, then MTA will be placed and the tooth will be restored as in group I. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- • Restorable vital and mature mandibular molar teeth with irreversible pulpitis.
Key exclusion criteria (8 listed)
- • Medically compromised patients with active systemic disease as uncontrolled diabetes mellitus, hypertension or cardiac diseases.
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 |
|---|---|---|
| low level laser device cryotherapyAlso: cryotherapyusing new device direct on the pulp tissue | Device | • Group II: LLLT following complete pulpotomy., • Group III: Cryotherapy following complete pulpotomy. |
Primary outcome
radiographic changes
Time frame: one year after treatment
and x-ray change either pulpal or periapical using CBCT subtraction
1 secondary outcome
Post operative pain
Time frame: one week after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 35929348Murray PE. Review of guidance for the selection of regenerative endodontics, apexogenesis, apexification, pulpotomy, and other endodontic treatments for immature permanent teeth. Int Endod J. 2023 Mar;56 Suppl 2:188-199. doi: 10.1111/iej.13809. Epub 2022 Aug 15.
- Background: PubMed 36334098Duncan HF, El-Karim I, Dummer PMH, Whitworth J, Nagendrababu V. Factors that influence the outcome of pulpotomy in permanent teeth. Int Endod J. 2023 Mar;56 Suppl 2:62-81. doi: 10.1111/iej.13866. Epub 2022 Nov 22.
- Individual participant dataSharing planned: No
Related trials for MTA Vital Tooth Pulpotomy
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Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars
Pulp Disease, Dental, Pulp Therapy in Primary Molars
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R. Officinalis as Pulpotomy Agent in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis, Pulpotomy
Enrolling by invitation
Effect of Ferric Sulphate and Putty MTA as Pulpotomy Agent in Vital Primary Teeth
Pulptomy, Dental Caries
Not yet recruiting
Effect of Graphene Oxide on Vital and Non-Vital Primary Teeth Compared to the Conventional Techniques
Primary Teeth Indicated for Pulp Therapy
Active, not recruiting
Evaluation of Two Different Calcium Silicate Cements as a Treatment for Irreversible Pulpitis in Mature Molars
Irreversible Pulpitis
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.
abeer darrag, phd principal investigator
Professor of Endodontics
tokka moukhatar study director
Lecturer of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser device cryotherapy in people with MTA Vital Tooth Pulpotomy, run by Tanta University 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Dec 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohamed motiea, bachelor (01002249832, Mohamed7942staff@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic changes (time frame: one year 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 NCT06711081, which also lists 2 linked publications.
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 2 Dec 2024.