Irreversible PulpitisNCT06904781
Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Irreversible Pulpitis
A study testing Pulpotomy and Pulpectomy in people with Irreversible Pulpitis, run by Qatar University at 2 sites in 2 countries.
Trial summary
This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Pulpotomy and Pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2025to 30 Jun 2028
- Phase
- Interventional
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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.
- Participants have symptoms typical of irreversible pulpitis in one of the primary molars.
- The pulp of the affected primary molar is vital.
- Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation.
- The affected primary molars can be restored with full coverage stainless steel crowns.
- Any physiologic root resorption, if present, is less than ⅓ the root length.
Who cannot join
- Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling).
- Pre-operative periapical radiograph suggests presence of periapical radiolucency or pathologic root resorption.
- Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
- Signs of extensive radicular pulp inflammation i.e., root pulp bleeding continues even after 6-min.
- Parents not willing to place full coverage crowns post-treatment.
- Clinical diagnosis of irreversible pulpitis between two adjacent primary molars is not sharply defined.
- Unable to perform clinical procedure under rubber dam
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid
Thikrayat Bani-Hani, Masters Paediatric Dentistry, tgbanihani@just.edu.jo
About this study
Official title: Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Non-inferiority Randomised Controlled Trial
This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared to the standard pulpectomy treatment, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, while retaining the proprioceptive sensation of the tooth - all important advantages when treating young children.
Read the detailed description
Background: Pulpectomy continues to be the standard treatment recommendation for management of vital primary molars diagnosed with symptomatic irreversible pulpitis. The recent decade has seen a paradigm shift in the treatment concepts of how vital mature permanent molars diagnosed with irreversible pulpitis can be more conservatively managed using vital pulp therapy techniques like pulpotomy. However, despite emerging evidence indicating similarities between primary and permanent tooth pulp response to dental caries, there is limited research on whether pulpotomy can be similarly used as a definitive treatment modality for vital primary teeth with irreversible pulpitis. This randomised controlled trial (RCT) aims to compare the treatment effectiveness of pulpotomy versus pulpectomy in management of vital primary molars diagnosed with symptomatic irreversible pulpitis over a two-year period.
Methods/Design: This clinical study is a parallel, two-armed, open label, non-inferiority RCT with a 1:1 allocation ratio between the experimental intervention arm (pulpotomy) and the active comparator arm (pulpectomy). Healthy cooperative children, between 4-9 years of age, who have painful primary molars with clinical symptoms typical of irreversible pulpitis will be recruited after obtaining informed consent from their parents/legal guardians. 80 vital primary molars clinically diagnosed with symptomatic irreversible pulpitis will be randomly distributed between the two treatment arms. The primary outcomes that will be assessed are clinical success after one-year and two-years of the trial interventions. The influence of baseline pre-operative variables (age; gender; tooth type; site of caries; pre-operative furcal radiolucency; pre-operative pain intensity) and intra-operative factors (time taken to achieve haemostasis) on treatment outcomes will also be assessed. The secondary outcomes evaluated will be the immediate (24 h and 7 d) post-operative pain relief afforded by the two treatment interventions, and the radiographic success after one-year and two-years of the trial interventions.
Discussion: This trial seeks to provide evidence on whether pulpotomy treatment can be no worse than the standard pulpectomy treatment for the management of symptomatic irreversible pulpitis in vital primary molars.
- Conditions
- Irreversible Pulpitis
- Being tested
- Pulpotomy, Pulpectomy
- Keywords
- Pulpectomy, Pulpotomy, Vital primary molars, Irreversible pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Pulpotomy is a conservative pulp treatment option where only the coronal pulp is removed and a bioactive medicament (MTA) is placed over the remnant radicular pulp after haemostasis is achieved.
PulpectomyProcedure or surgery
Pulpectomy is treatment procedure in primary teeth where the entire coronal and radicular pulp is extirpated and the root canal system filled with a resorbable material (Vitapex/Metapex)
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpotomy treatment intervention Receives: Procedure: Pulpotomy |
| Pulpectomy | Active comparator | Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpectomy treatment intervention. Receives: Procedure: Pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment clinical outcomes based on presence/absence of pain, tenderness, or signs of infection/pathologic mobility
Clinical outcome success will be determined at 6-, 12-, and 24-months based on the treated tooth meeting all the below criteria: (i) Treated tooth is not associated with any pain or discomfort; (ii) Treated tooth is not associated with tenderness on percussion or palpation; (iii) Treated tooth is not associated with any swelling, parulis, or fistula; (iv) Treated tooth is not associated with any pathological mobility
Measured: 6 months; 12 months; 24 months
Secondary outcomes (2)
Post-treatment radiographic outcomes based on presence/absence of pathologic root resorption, new furcal or periapical lesions, or size change of any pre-treatment furcal rarefaction
Radiographic outcome success will be determined at 6-, 12-, and 24-months based on the pulpotomy treated tooth meeting all the below criteria: - No signs of pathological internal/external root resorption or new furcal/periapical lesions on recall periapical radiographs - Complete radiographic healing or reduction/no change in size of any pre-treatment furcal rarefaction on recall periapical radiographs
Measured: 6 months; 12 months; 24 months
Immediate post-treatment pain relief
Pain scores that will be recorded at 24-hours and 7-days post-treatment using a child friendly Visual Analogue Scale (VAS). The VAS has five-point pain score: 0-No Pain; 1-Mild Pain; 2-Moderate Pain; 3-Severe Pain; and 4-Very Severe Pain. This VAS pain score will be used to evaluate pain reduction afforded by the treatment intervention.
Measured: 24 hours; 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Aug 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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
- Non-inferiority randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qatar University
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology, Primary Health Care Corporation, Qatar, Cairo University, Christian Dental College
- Responsible party
- Principal investigator, Nebu Philip, Qatar University
- Investigators
- Nebu Philip, MDS, PhD, Principal investigator, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904781
- Sponsor's protocol ID
- 2025_RCT
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No