Irreversible PulpitisNCT05427851
Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis
A study testing pulpotomy and Diode laser - fonalaser in people with Irreversible Pulpitis, run by Alexandria University at 1 site in Egypt.
Trial summary
Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- pulpotomy and Diode laser - fonalaser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2019to 1 Sep 2022
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 18 and 40 years of age.
- Deep caries in a permanent lower molar with mature roots.
- Clinical diagnosis of symptomatic irreversible pulpitis
- No signs of pulpal necrosis including sinus tract or swelling.
- Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.
- The tooth is restorable.
Who cannot join
- Patients with systemic disease.
- Negative response to cold testing.
- Presence of sinus tract or swelling.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled
- Absence of bleeding from any of the canals.
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- Teeth with radiographic signs of internal resorption.
- Pulpal calcifications.
- Non-restorable teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Diode Laser And Platelet Rich Fibrin In Regenerative Pulpotomy Of Mature Permanent Molars With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)
Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed.
Read the detailed description
For each patient, a pulpotomy procedure is done. Group I (n=12) pulpotomy is performed and hemostasis is achieved by applying NaOCl, then the radicular pulp is covered with Platelet Rich Fibrin (PRF) and capped with Biodentine, Group II (n=12) pulpotomy is done as in group I and hemostasis is achieved using diode laser and remaining pulp is capped with Biodentine, Group III (n=12) pulpotomy is performed and hemostasis is achieved as in group II then radicular pulp is covered with PRF then capped with Biodentine, The teeth are then restored with Glass ionomer cement followed by composite restoration. Pain is recorded every 24 hours for 7 days after intervention. Clinical and radiographic follow-up are done at 1,3,6,9 and 12 months. Cone beam computed tomography (CBCT) is done immediate postoperative and will be used for the assessment of the outcome of the pulpotomy procedure at the end of the study period.
- Conditions
- Irreversible Pulpitis
- Being tested
- pulpotomy, Diode laser - fonalaser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpotomyProcedure or surgery
coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material
Diode laser - fonalaserDevice
diode laser beam application
| Study group | Role | What they receive |
|---|---|---|
| Group I: Platelet rich Fibrin (PRF) and Biodentine | Experimental | Not described Receives: Procedure: pulpotomy |
| Group II: Diode Laser and Biodentine | Experimental | Not described Receives: Procedure: pulpotomy; Device: Diode laser - fonalaser |
| Group III: Diode laser + PRF + Biodentine | Experimental | Not described Receives: Procedure: pulpotomy; Device: Diode laser - fonalaser |
What is being measured
The primary outcome is the main question the study is designed to answer.
regenerative pulpotomy success
Assessing the clinical and radiographic success rate of the regenerative pulpotomy. • Teeth were considered as clinical success if patients had lack of pain (spontaneous or on chewing), sinus tract or swelling, pathological mobility, and had intact coronal restoration.( procedure done in permanent mature teeth with irreversible pulpitis.
Treatment was considered radiographically successful if no pathosis was evident on the recall radiograph such as root resorption, no furcal or periapical rarefaction. Periapical Index (PAI) was used to evaluate the periapical tissue condition by comparing the pre-operative radiographs with the follow-up radiographs.
Measured: 12 months
Secondary outcomes (1)
Postoperative pain
To evaluate the effect of Diode laser on decreasing the immediate postoperative pain. Postoperative pain was recorded on Numerical Rating Pain Scale (NRS) that was given to the patient in Arabic language to record his pain experience every 24 hours until the seventh day after the first appointment.
Pain on the NRS was further categorized as:(0)no pain, (1-3) mild, (4-6) moderate, (7-10) Severe pain.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start10 Apr 2019
- Primary completion1 May 2021
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raef A sherif, PhD, Study director, Professor of Endodontics, Faculty of Dentistry, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427851
- Sponsor's protocol ID
- Darinemamdouh
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Diode Laser And Platelet Rich Fibrin In Regenerative Pulpotomy Of Mature Permanent Molars With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05427851
- Acronym / sponsor ID
- Darinemamdouh
- Conditions
- Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 22 Jun 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.
Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed.
Detailed description
For each patient, a pulpotomy procedure is done. Group I (n=12) pulpotomy is performed and hemostasis is achieved by applying NaOCl, then the radicular pulp is covered with Platelet Rich Fibrin (PRF) and capped with Biodentine, Group II (n=12) pulpotomy is done as in group I and hemostasis is achieved using diode laser and remaining pulp is capped with Biodentine, Group III (n=12) pulpotomy is performed and hemostasis is achieved as in group II then radicular pulp is covered with PRF then capped with Biodentine, The teeth are then restored with Glass ionomer cement followed by composite restoration. Pain is recorded every 24 hours for 7 days after intervention. Clinical and radiographic follow-up are done at 1,3,6,9 and 12 months. Cone beam computed tomography (CBCT) is done immediate postoperative and will be used for the assessment of the outcome of the pulpotomy procedure at the end of the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I: Platelet rich Fibrin (PRF) and Biodentine | Experimental | Procedure: pulpotomy |
| Group II: Diode Laser and Biodentine | Experimental | Procedure: pulpotomy, Device: Diode laser - fonalaser |
| Group III: Diode laser + PRF + Biodentine | Experimental | Procedure: pulpotomy, Device: Diode laser - fonalaser |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients between 18 and 40 years of age.
- Deep caries in a permanent lower molar with mature roots.
- Clinical diagnosis of symptomatic irreversible pulpitis
- No signs of pulpal necrosis including sinus tract or swelling.
- Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.
Key exclusion criteria (9 listed)
- Patients with systemic disease.
- Negative response to cold testing.
- Presence of sinus tract or swelling.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled
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 |
|---|---|---|
| pulpotomycoronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material | Procedure or surgery | Group I: Platelet rich Fibrin (PRF) and Biodentine, Group II: Diode Laser and Biodentine, Group III: Diode laser + PRF + Biodentine |
| Diode laser - fonalaserdiode laser beam application | Device | Group II: Diode Laser and Biodentine, Group III: Diode laser + PRF + Biodentine |
Primary outcome
regenerative pulpotomy success
Time frame: 12 months
Assessing the clinical and radiographic success rate of the regenerative pulpotomy. • Teeth were considered as clinical success if patients had lack of pain (spontaneous or on chewing), sinus tract or swelling, pathological mobility, and had intact coronal restoration.( procedure done in permanent mature teeth with irreversible pulpitis. Treatment was considered radiographically successful if no pathosis was evident on the recall radiograph such as root resorption, no furcal or periapical rarefaction. Periapical Index (PAI) was used to evaluate the periapical tissue condition by comparing the pre-operative radiographs with the follow-up radiographs.
1 secondary outcome
Postoperative pain
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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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.
Raef A sherif, PhD study director
Professor of Endodontics, Faculty of Dentistry, Alexandria 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 pulpotomy and Diode laser - fonalaser in people with Irreversible Pulpitis, run by Alexandria 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Jun 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?
Results are not available in the source record.
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?
regenerative pulpotomy success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2022.