Pulpitis ReversibleNCT06200818
Clinical, Radiographic and Patient Acceptance Evaluation of LASER Compared to Formocresol Pulpotomies inPrimary Molars
A study testing Diode laser, Er:CrYSGG and Formocresol in people with Pulpitis Reversible, run by Ain Shams University.
Trial summary
The goal of this clinical trial was to compare the clinical and radiographic success of laser versus formocresol pulpotomy in primary molars. The main questions it aimed to answer was: Does laser pulpotomy has higher clinical and radiographic success rate as formocresol pulpotomy in primary molars? Participants were… Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis Reversible
- What is being tested?
- Diode laser, Er:CrYSGG and Formocresol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2015to 15 Feb 2018
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Clinical criteria One or more primary teeth indicated for pulpotomy due to carious pulp exposure. No spontaneous pain No swelling No tenderness to percussion No pathological mobility No sinus tract opening No initially unsuccessful hemorrhage control. 2. Radiographic criteria Teeth without inter-radicular radiolucency No loss of lamina dura or widened periodontal ligament space No physiologic root resorption of more than one-third.
Who cannot join
- Clinical mobility Spontaneous pain Swelling Tenderness to percussion Pathological mobility Non restorable teeth. Teeth with necrotic pulp. Pre-operative radiographic pathology such as resorption, periradicular or furcal radiolucency, a widened periodontal ligament space, or physiological root resorption of more than one-third. Parents / Patients not willing to be a part of the study. Any kind of medical history contraindicating the pulp treatment.
About this study
Official title: Clinical, Radiographic and Patient's Acceptance
The goal of this clinical trial was to compare the clinical and radiographic success of laser versus formocresol pulpotomy in primary molars. The main questions it aimed to answer was:
- Does laser pulpotomy has higher clinical and radiographic success rate as formocresol pulpotomy in primary molars?
Participants were selected according to eligibility criteria to undergo pulpotomy for their lower primary molars under local anesthesia using one of the following techniques:
- Group 1: Formocresol
- Group 2: Diode laser Group 3: Er:CrYSGG laser Clinical and radiographic follow up were performed for 18 months
Read the detailed description
In all teeth, local anaesthesia was administered using 7.0 mg/kg 4% articane + 1: 100,000 epinephrine (with a maximum total dosage of 500 mg)
- Rubber dam isolation was done.
Access cavity preparation:
- In all groups, caries removal was done with a sterile #330 high-speed bur, and coronal access cavity preparation was done with a sterile #4 high-speed round bur using high speed hand piece and water coolant. The access cavity was then refined using a sterile high-speed fissure bur. LASER operating parameters: Figure (10)
- Wavelength: 2780 nm
- Repetition rate: 15 Hz
- Water spray: 80
- Air : 60
- Emission mode: Free-running pulsed
- Tip: MZ 10- 6 mm, Zip Tip
- Average power: 8 Watt The coronal pulp was amputated by a sterile sharp excavator, the amputated sites were rinsed with water. Hemorrhage was controlled by placing sterile, saline- wetted cotton pellets on the radicular pulp stumps under slight pressure (Thompson et al., 2001) for 5 min for primary hemostasis ( J Dent Res 84(12) 2005). At this stage, the achievement of complete hemostasis was an inclusion criterion. If bleeding recommenced afterwards, partial pulpectomy was performed and the tooth was excluded from the study.
- After achieving complete haemostasis pulp stumps were treated according to each group: Group1: (control group)
- A cotton pellet that was moistened with 1:5 diluted bottle of FC (Formacresol, PREVEST DenPro, Digiana, Jammu, India) was placed over the pulp stumps for 5 minutes. After removal of the cotton, the fixed pulp stumps were capped with reinforced zinc oxide and eugenol base (Zinconol, PREVEST DenPro, Digiana, Jammu, India). Group2: (Diode LASER group)
- All patients, parents and clinical staff were requested to wear appropriate eye protection goggles during laser application, Figure (12). After achieving hemostasis, pulp stumps was treated with Diode LASER (980 nm).If hemostasis was not achieved, the process was repeated one more time until adequate hemostasis was achieved, Figure (15, 16). Diode LASER radiation (wavelength 980 nm) was delivered to the canal orifices with a special handpiece and fiber glass of 200 μm diameter, Figure (13), the parameters were set at: Figure (14) Emission mode: Pulsed contact mode Time: 2 seconds. Power: 2 Watt power with average power of 1 Watt and total energy of one spot, corresponding to two minutes and 31 seconds exposure was 4.0 J/cm 2. Group3: (Erbium:Chromium,YSGG LASER group) Pulp tissues in this group were treated with Erbium:Chromium,YSGG LASER (2780 nμ). (Waterlase Biolase®, Biolase, Inc., San Clemente, California, USA) Once the pulp chamber was opened, the laser tip was placed into the pulp chamber using for approximately 15 seconds. In most instances, this was repeated three times. If hemostasis was not achieved, the process was repeated one more time until adequate hemostasis was achieved. Er: Cr, YSGG LASER radiation (wavelength 2780 nμ) was delivered with a special handpiece, and a tip: MZ 10- 6 mm, Zip Tip, to the canal orifices.
LASER operating parameters:
- Wavelength: 2780 nm
- Repetition rate: 50 Hz
- Water spray: 1
- Air : 20
- Emission mode: Free-running pulsed In all groups, reinforced zinc oxide eugenol cement was placed over the pulp stumps, and the tooth was restored with a stainless steel crown. Preoperative and postoperative as well as follow up periapical radiographs at 6, 12 and18 months were obtained by standardized paralleling technique and exposure time of 0.25 seconds. An XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland) was used. Digital radiographs were obtained and scanned using size 0 phosphostimulable phosphor plates [X mind AC (de Gotzen, Italy) and Fona-Scaneo, phosphor plate scanner, respectively.
- Conditions
- Pulpitis Reversible
- Being tested
- Diode laser, Er:CrYSGG, Formocresol
- Keywords
- Pulp, vital pulp therapy, pulpotomy, formocresol, diode, erbium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserProcedure or surgery
Er:CrYSGGProcedure or surgery
FormocresolProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Formocresol | Active comparator | Not described Receives: Procedure: Formocresol |
| Diode laser | Experimental | Not described Receives: Procedure: Diode laser |
| Er:CrYSGG | Experimental | Not described Receives: Procedure: Er:CrYSGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success
Clinical success criteria:
- Restoration intact;
- No pain or tenderness;
- No mobility;
- No swelling;
- No fistula;
- No gingival inflammation-represented by pain, redness, or bleeding-around the tooth/crown. Radiographic success at follow-up visits should meet the following criteria:
- No external root resorption; 2. No internal root resorption; 3. No inter-radicular bone resorption. 4. No Widening of the periodontal ligament space. 5. No periapical bone resorption.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start20 Dec 2015
- Primary completion30 Dec 2017
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis ReversibleStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Hamdy, Ain Shams University
- Investigators
- Dina Hamdy, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200818
- Sponsor's protocol ID
- FDASU-RecD061519
- Status last verified
- Dec 2023
- First submitted
- 31 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Patient's Acceptance
- ClinicalTrials.gov ID
- NCT06200818
- Acronym / sponsor ID
- FDASU-RecD061519
- Conditions
- Pulpitis Reversible
- Keywords
- Pulp, vital pulp therapy, pulpotomy, formocresol, diode, erbium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Dec 2015 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 11 Jan 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.
The goal of this clinical trial was to compare the clinical and radiographic success of laser versus formocresol pulpotomy in primary molars. The main questions it aimed to answer was:
- Does laser pulpotomy has higher clinical and radiographic success rate as formocresol pulpotomy in primary molars?
Participants were selected according to eligibility criteria to undergo pulpotomy for their lower primary molars under local anesthesia using one of the following techniques:
- Group 1: Formocresol
- Group 2: Diode laser Group 3: Er:CrYSGG laser Clinical and radiographic follow up were performed for 18 months
Detailed description
In all teeth, local anaesthesia was administered using 7.0 mg/kg 4% articane + 1: 100,000 epinephrine (with a maximum total dosage of 500 mg)
- Rubber dam isolation was done.
Access cavity preparation:
- In all groups, caries removal was done with a sterile #330 high-speed bur, and coronal access cavity preparation was done with a sterile #4 high-speed round bur using high speed hand piece and water coolant. The access cavity was then refined using a sterile high-speed fissure bur. LASER operating parameters: Figure (10)
- Wavelength: 2780 nm
- Repetition rate: 15 Hz
- Water spray: 80
- Air : 60
- Emission mode: Free-running pulsed
- Tip: MZ 10- 6 mm, Zip Tip
- Average power: 8 Watt The coronal pulp was amputated by a sterile sharp excavator, the amputated sites were rinsed with water. Hemorrhage was controlled by placing sterile, saline- wetted cotton pellets on the radicular pulp stumps under slight pressure (Thompson et al., 2001) for 5 min for primary hemostasis ( J Dent Res 84(12) 2005). At this stage, the achievement of complete hemostasis was an inclusion criterion. If bleeding recommenced afterwards, partial pulpectomy was performed and the tooth was excluded from the study.
- After achieving complete haemostasis pulp stumps were treated according to each group: Group1: (control group)
- A cotton pellet that was moistened with 1:5 diluted bottle of FC (Formacresol, PREVEST DenPro, Digiana, Jammu, India) was placed over the pulp stumps for 5 minutes. After removal of the cotton, the fixed pulp stumps were capped with reinforced zinc oxide and eugenol base (Zinconol, PREVEST DenPro, Digiana, Jammu, India). Group2: (Diode LASER group)
- All patients, parents and clinical staff were requested to wear appropriate eye protection goggles during laser application, Figure (12). After achieving hemostasis, pulp stumps was treated with Diode LASER (980 nm).If hemostasis was not achieved, the process was repeated one more time until adequate hemostasis was achieved, Figure (15, 16). Diode LASER radiation (wavelength 980 nm) was delivered to the canal orifices with a special handpiece and fiber glass of 200 μm diameter, Figure (13), the parameters were set at: Figure (14) Emission mode: Pulsed contact mode Time: 2 seconds. Power: 2 Watt power with average power of 1 Watt and total energy of one spot, corresponding to two minutes and 31 seconds exposure was 4.0 J/cm 2. Group3: (Erbium:Chromium,YSGG LASER group) Pulp tissues in this group were treated with Erbium:Chromium,YSGG LASER (2780 nμ). (Waterlase Biolase®, Biolase, Inc., San Clemente, California, USA) Once the pulp chamber was opened, the laser tip was placed into the pulp chamber using for approximately 15 seconds. In most instances, this was repeated three times. If hemostasis was not achieved, the process was repeated one more time until adequate hemostasis was achieved. Er: Cr, YSGG LASER radiation (wavelength 2780 nμ) was delivered with a special handpiece, and a tip: MZ 10- 6 mm, Zip Tip, to the canal orifices.
LASER operating parameters:
- Wavelength: 2780 nm
- Repetition rate: 50 Hz
- Water spray: 1
- Air : 20
- Emission mode: Free-running pulsed In all groups, reinforced zinc oxide eugenol cement was placed over the pulp stumps, and the tooth was restored with a stainless steel crown. Preoperative and postoperative as well as follow up periapical radiographs at 6, 12 and18 months were obtained by standardized paralleling technique and exposure time of 0.25 seconds. An XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland) was used. Digital radiographs were obtained and scanned using size 0 phosphostimulable phosphor plates [X mind AC (de Gotzen, Italy) and Fona-Scaneo, phosphor plate scanner, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formocresol | Active comparator | Procedure: Formocresol |
| Diode laser | Experimental | Procedure: Diode laser |
| Er:CrYSGG | Experimental | Procedure: Er:CrYSGG |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Clinical criteria One or more primary teeth indicated for pulpotomy due to carious pulp exposure. No spontaneous pain No swelling No tenderness to percussion No pathological mobility No sinus tract opening No initially unsuccessful hemorrhage control. 2. Radiographic criteria Teeth without inter-radicular radiolucency No loss of lamina dura or widened periodontal ligament space No physiologic root resorption of more than one-third.
Key exclusion criteria (1 listed)
- Clinical mobility Spontaneous pain Swelling Tenderness to percussion Pathological mobility Non restorable teeth. Teeth with necrotic pulp. Pre-operative radiographic pathology such as resorption, periradicular or furcal radiolucency, a widened periodontal ligament space, or physiological root resorption of more than one-third. Parents / Patients not willing to be a part of the study. Any kind of medical history contraindicating the pulp treatment.
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 | Procedure or surgery | Diode laser |
| Er:CrYSGG | Procedure or surgery | Er:CrYSGG |
| Formocresol | Procedure or surgery | Formocresol |
Primary outcome
Clinical and radiographic success
Time frame: 18 months
Clinical success criteria: 1. Restoration intact; 2. No pain or tenderness; 3. No mobility; 4. No swelling; 5. No fistula; 6. No gingival inflammation-represented by pain, redness, or bleeding-around the tooth/crown. Radiographic success at follow-up visits should meet the following criteria: 1. No external root resorption; 2. No internal root resorption; 3. No inter-radicular bone resorption. 4. No Widening of the periodontal ligament space. 5. No periapical bone resorption.
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 11 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Pulpitis Reversible
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Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth
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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.
Dina Hamdy principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser, Er:CrYSGG and Formocresol in people with Pulpitis Reversible, run by Ain Shams University.
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 1 inclusion and 1 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical and radiographic success (time frame: 18 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 11 Jan 2024.