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Not yet recruitingNCT06675058Updated Nov 5, 2024

Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars

An interventional study of Indirect Pulp Treatment in Deep Caries Lesion of Primary Teeth, Dental Pulp Diseases and Deep Proximal Caries, sponsored by Cairo University. Not yet recruiting. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2024-11-05.

Primary conditionPulpitisRegistry: Dental Pulp DiseasesReclassifiedWhy we changed it
Registry
Dental Pulp Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pulpitis
Why
  1. The study's listed conditions name Pulpitis, a narrower term within Dental Pulp Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
3 Years to 7 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 59 studies in Pulpitis by Cairo University — 19 open to participants now, 19 under way, none of them phase 3. Pulpitis · Cairo University.

Planned enrollment
30th of 58
50 · median 51
Started
2024
with 2 others
No phase
44 of 59
16 open now
Primary completion
2026-08
later than 9 of 18 live
Registered
46th of 59
by date

Among the 59 studies in Pulpitis by Cairo University, this one is the 30th largest by planned enrollment of the 58 interventional ones that give a count, is one of 3 that started in 2024, is one of 44 with no phase, reaches primary completion later than 9 of the 18 other live ones, and was the 46th registered.

Pulpitis

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

Browse Pulpitis studies →

Open to participants now

19 of the 59 studies in Pulpitis by Cairo University are open now, in 1 country. Recruiting first, the newest first:

13 more — sign in →

By country, each count listing its studies:

All 19 open studies →

Where they have run

Who these studies take

Of the 41 Pulpitis studies recruiting now, 9 (22%) set no upper age limit and 32 (78%) stop at 75 or younger; 19 take children under 18; 24 take healthy volunteers.

This study: 3 Years to 7 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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 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.

03

Conditions studied

  • Deep Caries Lesion of Primary Teeth
  • Dental Pulp Diseases
  • Deep Proximal Caries
  • Deep Occlusal Caries
  • Reversible Pulpitis
  • Pulpitis
  • Decayed Teeth

Browse trials for

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
04

In context

Pulpitis Reclassified

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's planned enrollment of 50 is below the median of 64 across 288 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Compared within Pulpitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dental Pulp Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant criteria:

    1. Children aged between 3-7 years
    2. Children in complete physical and mental health.
    3. Children with free medical history.
    4. Patient with favorable attitudes, which will be assessed by using Frankl behavior rating.

Teeth criteria:

  1. Primary molars with active occlusal or proximal deep caries.
  2. Teeth with reversible pulpitis
  3. Asymptomatic teeth or teeth with provoked pain of short duration
  4. Teeth should be restorable.

Exclusion criteria

Exclusion Criteria:

  • 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:

  • Periapical or inter-radicular radiolucency.
  • Internal or external pathological root resorption.
  • Furcation involvement
  • Widening of periodontal space.
06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Primary teeth with deep proximal caries

    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.

    Procedure: Indirect Pulp Treatment

  • Active comparator
    Primary teeth with deep occlusal caries

    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

    Procedure: Indirect Pulp Treatment

Interventions

  • ProcedureIndirect Pulp Treatment

    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.

07

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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 )

    Time frame: one year follow up

08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2024; primary completion for Aug 2026, 20 months later.

Of 158 non-industry interventional studies with no phase under Pulpitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's planned 20 months is above that.

Counting every sponsor, half of 158 studies reached it within 16 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2024
First posted
Nov 5, 2024
StartEst.
Dec 1, 2024
Primary completionEst.
Aug 1, 2026
CompletionEst.
Aug 18, 2026
Last update
Nov 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06675058
Lead sponsor
Cairo University
Responsible party
Yomna Hussein Moselhy Sayed Ahmed (Dr. Yomna Hussein Moselhy, Cairo University) — Principal investigator
First posted
Nov 5, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 18, 2026 (estimated)
Last update
Nov 5, 2024

Study contacts

Yomna Hussein Moselhy, Phd Candidate at Cairo Uni
Contact
dr.yomnahussein.edu@gmail.com
01145566717 ext. 01090058699
Dr. Adel Abdel Azeem EL-Bardissy, Professor
Contact
adelbardissy@dentistry.cu.edu.eg
01271289999

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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