Dental TraumaNCT05921500
Clinical and Radiographic Evaluation of Intra Coronal Bleaching of Primary Anterior Teeth
A study testing sodium peborate in people with Dental Trauma, run by Al-Azhar University at 1 site in Egypt.
Trial summary
clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Trauma
- What is being tested?
- sodium peborate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Aug 2023
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 3-5 years.
- Parents/caregivers acceptance.
- Traumatized anterior teeth with sensitivity to percussion and palpation with gray discoloration.
- Discolored anterior teeth indicated for intracoronal bleaching.
- Traumatized anterior teeth no response to an electric pulp test.
- Discolored teeth with satisfactorily previously obturated root canal .
- Absence of preapical lesions or apex resorption.
Who cannot join
- Teeth with signs tooth mobility indicated for extraction.
- Teeth with vertical root fracture.
- Teeth with preapical lesions or apex resorption.
- Teeth with discolorations from restorative materials.
- Children with lack of cooperation for post-operative recall and follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Intra Coronal Bleaching of Primary Anterior Teeth Using Sodium Perborate With Walking Bleach Technique
clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique
Read the detailed description
This study will be conducted for the clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique
- Conditions
- Dental Trauma
- Being tested
- sodium peborate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium peborateDrug
Internal bleaching of discolored primary anterior teeth by using sodium peborate
| Study group | Role | What they receive |
|---|---|---|
| Internal bleaching of discolored primary anterior teeth by using sodium peborate | Experimental | Internal bleaching of discolored primary anterior teeth by using sodium peborate Receives: Drug: sodium peborate |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation of internal bleaching of primary teeth
Clinical outcomes:
During the follow-up period- two weeks to month, signs of any pathology will be observed clinically and scored as follow:
- Sensitivity to percussion or palpation (positive or negative).
- Abscess or fistulae (positive or negative).
- Color change recorded by vita shade 3d master.
Measured: two weeks to month
Secondary outcomes (1)
radiographic evaluation of internal bleaching of primary teeth
Radiographically outcomes:
During the follow-up period - six months, signs of any pathology will be observed radiographically and scored as follow:
- External or internal root resorption (positive or negative).
- Apical radiolucency (positive or negative).
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 May 2022
- Primary completion1 May 2022
- Study completion1 Aug 2023 (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 Dental TraumaStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohammed Bedir, Al-Azhar University
- Investigators
- alaa eldin mohamed, associate professor, Study director, associate professorhamdy badreldin, lecture, Study director, lecture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921500
- Sponsor's protocol ID
- internal bleaching
- Status last verified
- Jun 2023
- First submitted
- 3 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arikan V, Sari S, Sonmez H. Bleaching a devital primary tooth using sodium perborate with walking bleach technique: a case report. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 May;107(5):e80-4. doi: 10.1016/j.tripleo.2009.01.050.
PubMed 19426913Sharma DS, Barjatya K, Agrawal A. Intra-coronal bleaching in young permanent and primary tooth with biologic perspectives. J Clin Pediatr Dent. 2011 Summer;35(4):349-52. doi: 10.17796/jcpd.35.4.p372w1h5j2kg5734.
PubMed 22046690
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Intra Coronal Bleaching of Primary Anterior Teeth Using Sodium Perborate With Walking Bleach Technique
- ClinicalTrials.gov ID
- NCT05921500
- Acronym / sponsor ID
- internal bleaching
- Conditions
- Dental Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 27 Jun 2023 (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.
clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique
Detailed description
This study will be conducted for the clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internal bleaching of discolored primary anterior teeth by using sodium peborate | Experimental | Drug: sodium peborateInternal bleaching of discolored primary anterior teeth by using sodium peborate |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged between 3-5 years.
- Parents/caregivers acceptance.
- Traumatized anterior teeth with sensitivity to percussion and palpation with gray discoloration.
- Discolored anterior teeth indicated for intracoronal bleaching.
- Traumatized anterior teeth no response to an electric pulp test.
Key exclusion criteria (5 listed)
- Teeth with signs tooth mobility indicated for extraction.
- Teeth with vertical root fracture.
- Teeth with preapical lesions or apex resorption.
- Teeth with discolorations from restorative materials.
- Children with lack of cooperation for post-operative recall and follow up.
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 |
|---|---|---|
| sodium peborateInternal bleaching of discolored primary anterior teeth by using sodium peborate | Drug | Internal bleaching of discolored primary anterior teeth by using sodium peborate |
Primary outcome
clinical evaluation of internal bleaching of primary teeth
Time frame: two weeks to month
Clinical outcomes: During the follow-up period- two weeks to month, signs of any pathology will be observed clinically and scored as follow: 1. Sensitivity to percussion or palpation (positive or negative). 2. Abscess or fistulae (positive or negative). 3. Color change recorded by vita shade 3d master.
1 secondary outcome
radiographic evaluation of internal bleaching of primary teeth
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 19426913Arikan V, Sari S, Sonmez H. Bleaching a devital primary tooth using sodium perborate with walking bleach technique: a case report. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 May;107(5):e80-4. doi: 10.1016/j.tripleo.2009.01.050.
- Background: PubMed 22046690Sharma DS, Barjatya K, Agrawal A. Intra-coronal bleaching in young permanent and primary tooth with biologic perspectives. J Clin Pediatr Dent. 2011 Summer;35(4):349-52. doi: 10.17796/jcpd.35.4.p372w1h5j2kg5734.
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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.
alaa eldin mohamed, associate professor study director
associate professor
hamdy badreldin, lecture study director
lecture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium peborate in people with Dental Trauma, run by Al-Azhar 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 7 inclusion and 5 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 27 Jun 2023. 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?
clinical evaluation of internal bleaching of primary teeth (time frame: two weeks to month). 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 NCT05921500, 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 27 Jun 2023.