Deep Caries Lesion of Primary TeethNCT06675058
Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars
A study testing Indirect Pulp Treatment in people with Deep Caries Lesion of Primary Teeth and Dental Pulp Diseases, run by Cairo University.
Trial summary
The following study will be created to evaluate how the location of caries affects the effectiveness of indirect pulp treatment in primary molars. aiding in the development of evidence-based recommendations for pediatric dentists. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Deep Caries Lesion of Primary Teeth, Dental Pulp Diseases, Deep Proximal Caries
- What is being tested?
- Indirect Pulp Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 18 Aug 2026
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant criteria:
- Children aged between 3-7 years
- Children in complete physical and mental health.
- Children with free medical history.
- Patient with favorable attitudes, which will be assessed by using Frankl behavior rating.
- Teeth criteria:
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- Primary molars with active occlusal or proximal deep caries.
- Teeth with reversible pulpitis
- Asymptomatic teeth or teeth with provoked pain of short duration
- Teeth should be restorable.
Who cannot join
- Clinical signs or symptoms suggesting evidence of pulp degeneration or a non -vital tooth such as:
- Clinical symptoms or history indicating irreversible pulpitis as (spontaneous pain, throbbing pain).
- Tenderness to percussion.
- Soft tissue swelling, abscess, draining fistula or sinus tracts.
- Pathological Tooth mobility.
- Presence of the following Radiographic criteria:
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- Periapical or inter-radicular radiolucency.
- Internal or external pathological root resorption.
- Furcation involvement
- Widening of periodontal space.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yomna Hussein Moselhy, Phd Candidate at Cairo Uni contact
About this study
Official title: Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars: A Comparative Clinical Study
The following study will be created to evaluate how the location of caries affects the effectiveness of indirect pulp treatment in primary molars. aiding in the development of evidence-based recommendations for pediatric dentists.
Read the detailed description
A selective case study design will be employed, focusing on primary molars with either occlusal or proximal carious lesions. Children aged between 3 to 7 years meeting the inclusion criteria will be examined clinically and radiographically to assess the extent and location of the carious lesion. Two groups will be involved in the study; primary molars will be submitted to each group based on whether the lesion is proximal or occlusal. Both groups will then receive indirect pulp therapy, and a clinical and radiographic evaluation for one year will be conducted.
The purpose of this study is to examine how the location of caries, whether proximal or occlusal, affects the success rate of IPT in primary molars. Understanding this relationship is essential for developing more tailored clinical approaches in pediatric dentistry to ensure long-term treatment success.
- Conditions
- Deep Caries Lesion of Primary Teeth, Dental Pulp Diseases, Deep Proximal Caries, Deep Occlusal Caries, Reversible Pulpitis, Pulpitis
- Being tested
- Indirect Pulp Treatment
- Keywords
- Indirect Pulp Treatment, IPT, Caries location, Caries Site, Proximal and occlusal Caries, Proximal Caries, Occlusal Caries, Pulp Therapy, Reversible Pulpitis, Pulpitis, deciduous teeth, Caries in milk teeth
- Medical subject headings
- Dental Pulp Diseases, Pulpitis, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect Pulp TreatmentProcedure or surgery
Indirect pulp treatment is considered one of the most conservative pulp therapies, which preserves the pulp's vitality in teeth with reversible pulpitis. It has been chosen to be the intervention in both groups as the aim of this study is to assess the impact of caries location (proximal vs. occlusal caries) in influencing the success rate of IPT.
| Study group | Role | What they receive |
|---|---|---|
| Primary teeth with deep proximal caries | Experimental | In primary molars with deep proximal caries indirect pulp treatment will be performed by removing infected dentin while affected dentin in pulpal floor will be left in place. Teeth will be capped by a dressing material. Receives: Procedure: Indirect Pulp Treatment |
| Primary teeth with deep occlusal caries | Active comparator | In primary molars with deep occlusal caries also IPT will be performed. Soft infected dentin will be carefully removed until the dried, hardened affected dentin with a leathery consistency reached then teeth will be capped by a dressing material Receives: Procedure: Indirect Pulp Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT)
Clinical success rate will be assess through assessment of the following :
Post-operative Pain (percentage of absence of pain), Presence or absence of clinical signs (e.g., swelling, abscess, sinus tract), and Pain on Percussion
Measured: one year follow up
Secondary outcomes (1)
Radiographic success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT).
Radiographic Success Rate will be assess every (6, and 12 months) through assessment of the following in the x-ray film :
No radiographic evidence of periapical or inter-radicular radiolucency, No internal or external root resorption, No furcation involvement, and No widening in the periodontal membrane ligament )
Measured: one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion18 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Caries Lesion of Primary TeethStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- a Selective Case Study ( Prospective Clinical Trial)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Hussein Moselhy Sayed Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675058
- Sponsor's protocol ID
- 14422023530604
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT06675058
- Acronym / sponsor ID
- 14422023530604
- Conditions
- Deep Caries Lesion of Primary Teeth, Dental Pulp Diseases, Deep Proximal Caries, Deep Occlusal Caries, Reversible Pulpitis, Pulpitis
- Keywords
- Indirect Pulp Treatment, IPT, Caries location, Caries Site, Proximal and occlusal Caries, Proximal Caries, Occlusal Caries, Pulp Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 18 Aug 2026 (estimated)
- First posted
- 5 Nov 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 following study will be created to evaluate how the location of caries affects the effectiveness of indirect pulp treatment in primary molars. aiding in the development of evidence-based recommendations for pediatric dentists.
Detailed description
A selective case study design will be employed, focusing on primary molars with either occlusal or proximal carious lesions. Children aged between 3 to 7 years meeting the inclusion criteria will be examined clinically and radiographically to assess the extent and location of the carious lesion. Two groups will be involved in the study; primary molars will be submitted to each group based on whether the lesion is proximal or occlusal. Both groups will then receive indirect pulp therapy, and a clinical and radiographic evaluation for one year will be conducted.
The purpose of this study is to examine how the location of caries, whether proximal or occlusal, affects the success rate of IPT in primary molars. Understanding this relationship is essential for developing more tailored clinical approaches in pediatric dentistry to ensure long-term treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- a Selective Case Study ( Prospective Clinical Trial)
| Arm | Type | Receives |
|---|---|---|
| Primary teeth with deep proximal caries | Experimental | Procedure: Indirect Pulp TreatmentIn primary molars with deep proximal caries indirect pulp treatment will be performed by removing infected dentin while affected dentin in pulpal floor will be left in place. Teeth will be capped by a dressing material. |
| Primary teeth with deep occlusal caries | Active comparator | Procedure: Indirect Pulp TreatmentIn primary molars with deep occlusal caries also IPT will be performed. Soft infected dentin will be carefully removed until the dried, hardened affected dentin with a leathery consistency reached then teeth will be capped by a dressing material |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Participant criteria:
- Primary molars with active occlusal or proximal deep caries.
- Teeth with reversible pulpitis
- Asymptomatic teeth or teeth with provoked pain of short duration
- Teeth should be restorable.
Key exclusion criteria (10 listed)
- Clinical signs or symptoms suggesting evidence of pulp degeneration or a non -vital tooth such as:
- Periapical or inter-radicular radiolucency.
- Internal or external pathological root resorption.
- Furcation involvement
- Widening of periodontal space.
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 |
|---|---|---|
| Indirect Pulp TreatmentIndirect pulp treatment is considered one of the most conservative pulp therapies, which preserves the pulp's vitality in teeth with reversible pulpitis. It has been chosen to be the intervention in both groups as the aim of this study is to assess the impact of caries location (proximal vs. occlusal caries) in influencing the success rate of IPT. | Procedure or surgery | Primary teeth with deep occlusal caries, Primary teeth with deep proximal caries |
Primary outcome
Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT)
Time frame: one year follow up
Clinical success rate will be assess through assessment of the following : Post-operative Pain (percentage of absence of pain), Presence or absence of clinical signs (e.g., swelling, abscess, sinus tract), and Pain on Percussion
1 secondary outcome
Radiographic success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT).
Time frame: one year follow up
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 5 Nov 2024.
- Individual participant dataSharing planned: Undecided
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.
Yomna Hussein Moselhy, Phd Candidate at Cairo Uni contact
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Pulp Treatment in people with Deep Caries Lesion of Primary Teeth and Dental Pulp Diseases, run by Cairo 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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 5 Nov 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?
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 Yomna Hussein Moselhy, Phd Candidate at Cairo Uni (01145566717 ext. 01090058699, dr.yomnahussein.edu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT) (time frame: one year follow up). 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 5 Nov 2024.