PulpotomyNCT03782714
Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies
A study testing Low-level laser therapy in people with Pulpotomy, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
This study aimed to assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth. One hundred and six primary molars from 36 children aging five to eight years were included and randomly assigned into two equal groups; LLLT group and FC group. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy
- What is being tested?
- Low-level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2017to 1 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children inclusion criteria:
- Children aged 5-8 years with at least two bilateral deep carious primary molars indicated for pulpotomy.
- Children who are physically and mentally healthy without any known medical history of systemic conditions contraindicating pulp therapy.
- Children who had "positive" or "definitely positive" behavioral ratings according to the Frankl behavior classification scale (Frankl, 1962).
- Children whose parents signed an informed consent for the child's participation in the study.
- Teeth inclusion criteria:
Show all 17Show fewer
- Teeth were selected according to clinical and radiographic criteria.
- Clinically, the study included:
- Teeth with restorable crowns
- Teeth with pathologic carious exposure of vital pulps
- Teeth with no tenderness to percussion, physiologic or pathologic mobility or any clinical evidence of pulp inflammation or degeneration such as history of swelling, pain or presence of sinus tract.
- Radiographically, the recruited teeth should have:
- Normal radiographic appearance with healthy supporting tissues
- No pulp calcification
- No internal or external root resorption
- No periapical or inter-radicular radiolucency
- At least two thirds of the root remaining (not more than one third of the root is physiologically resorbed)
Who cannot join
- Any child complained of clinical signs such as pain, swelling, abnormal mobility, vertical or lateral tenderness to percussion was excluded from the study.
- Radiographically, any child with signs of internal or external root resorption or periapical or inter-radicular pathology was omitted from the study.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University, Dental University Hospital
Jeddah, 21589
About this study
Official title: Clinical and Radiographic Evaluation of Low-level Laser Therapy in Human Primary Molar Pulpotomies: A Randomized Controlled Clinical Trial
This study aimed to assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth. One hundred and six primary molars from 36 children aging five to eight years were included and randomly assigned into two equal groups; LLLT group and FC group. Teeth were evaluated clinically and radiographically at 3, 6 and 12 months.
Read the detailed description
Background: Various agents are available to dress the remaining pulp tissue after pulpotomy procedure with the formocresol (FC) being the gold standard for the last 60 years. Nowadays, low-level laser therapy (LLLT) becomes a technique of interest, due to its many characteristics. However, the literature available on its success in pulpotomy is limited and reported conflicting results.
Aim of the study: To assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth.
Materials and methods: Utilizing split-mouth technique, the sample consisted of 106 primary molars from 36 children aging five to eight years. The teeth were selected based on specific clinical and radiographic inclusion criteria and randomly assigned into two equal groups; LLLT group and FC group. All the 106 primary molars were indicated for pulpotomy, where 53 teeth were treated using FC and 53 teeth were treated with LLLT. Teeth were evaluated clinically and radiographically at 3, 6 and 12 months.
- Conditions
- Pulpotomy
- Being tested
- Low-level laser therapy
- Keywords
- Low-level laser therapy, pulpotomy, formocresol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyDevice
It is a diode laser device that has laser set at low level, used for pain relief and inflammation reduction to induce healing
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy group | Experimental | This group of teeth received laser irradiation after amputation of coronal pulp Receives: Device: Low-level laser therapy |
| Formocresol group | No intervention | This group of teeth received the gold standard medication (formocresol) after coronal pulp amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
Measured: 3 months
Clinical success rate
The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
Measured: 6 months
Clinical success rate
The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
Measured: 12 months
Radiographic success rate
The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria:
- Normal periodontal ligament space
- No inter-radicular or periapical radiolucency
- No internal or external root resorption
Measured: 3 months
Radiographic success rate
The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria:
- Normal periodontal ligament space
- No inter-radicular or periapical radiolucency
- No internal or external root resorption
Measured: 6 months
Radiographic success rate
The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria:
- Normal periodontal ligament space
- No inter-radicular or periapical radiolucency
- No internal or external root resorption
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Feb 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpotomyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a split-mouth randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Najlaa Alamoudi, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782714
- Sponsor's protocol ID
- Alaa Nadhreen
- Status last verified
- Dec 2018
- First submitted
- 16 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Low-level Laser Therapy in Human Primary Molar Pulpotomies: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03782714
- Acronym / sponsor ID
- Alaa Nadhreen
- Conditions
- Pulpotomy
- Keywords
- Low-level laser therapy, pulpotomy, formocresol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 20 Dec 2018 (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 study aimed to assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth. One hundred and six primary molars from 36 children aging five to eight years were included and randomly assigned into two equal groups; LLLT group and FC group. Teeth were evaluated clinically and radiographically at 3, 6 and 12 months.
Detailed description
Background: Various agents are available to dress the remaining pulp tissue after pulpotomy procedure with the formocresol (FC) being the gold standard for the last 60 years. Nowadays, low-level laser therapy (LLLT) becomes a technique of interest, due to its many characteristics. However, the literature available on its success in pulpotomy is limited and reported conflicting results.
Aim of the study: To assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth.
Materials and methods: Utilizing split-mouth technique, the sample consisted of 106 primary molars from 36 children aging five to eight years. The teeth were selected based on specific clinical and radiographic inclusion criteria and randomly assigned into two equal groups; LLLT group and FC group. All the 106 primary molars were indicated for pulpotomy, where 53 teeth were treated using FC and 53 teeth were treated with LLLT. Teeth were evaluated clinically and radiographically at 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a split-mouth randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy group | Experimental | Device: Low-level laser therapyThis group of teeth received laser irradiation after amputation of coronal pulp |
| Formocresol group | No intervention | –This group of teeth received the gold standard medication (formocresol) after coronal pulp amputation |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Children aged 5-8 years with at least two bilateral deep carious primary molars indicated for pulpotomy.
- Children who are physically and mentally healthy without any known medical history of systemic conditions contraindicating pulp therapy.
- Children who had "positive" or "definitely positive" behavioral ratings according to the Frankl behavior classification scale (Frankl, 1962).
- Children whose parents signed an informed consent for the child's participation in the study.
- Teeth were selected according to clinical and radiographic criteria.
Key exclusion criteria (2 listed)
- Any child complained of clinical signs such as pain, swelling, abnormal mobility, vertical or lateral tenderness to percussion was excluded from the study.
- Radiographically, any child with signs of internal or external root resorption or periapical or inter-radicular pathology was omitted from the study.
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 therapyIt is a diode laser device that has laser set at low level, used for pain relief and inflammation reduction to induce healing | Device | Low-level laser therapy group |
Primary outcome
Clinical success rate
Time frame: 3 months
The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
Clinical success rate
Time frame: 6 months
The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
Clinical success rate
Time frame: 12 months
The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
Radiographic success rate
Time frame: 3 months
The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: 1. Normal periodontal ligament space 2. No inter-radicular or periapical radiolucency 3. No internal or external root resorption
Radiographic success rate
Time frame: 6 months
The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: 1. Normal periodontal ligament space 2. No inter-radicular or periapical radiolucency 3. No internal or external root resorption
Radiographic success rate
Time frame: 12 months
The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: 1. Normal periodontal ligament space 2. No inter-radicular or periapical radiolucency 3. No internal or external root 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 20 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Pulpotomy
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Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
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Pomegranate Peel Extract for Primary Molar Pulpotomy
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Active, not recruiting
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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 study testing Low-level laser therapy in people with Pulpotomy, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 17 inclusion and 2 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 20 Dec 2018. 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 Saudi Arabia. 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?
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 success rate (time frame: 3 months). The study lists 6 primary outcomes in all. 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 20 Dec 2018.