Dental CariesNCT06524921
Biodentine Pulpotomy vs Metapex Pulpectomy in Primary Molars: Clinical & Radiographic Comparison of Outcomes in Irreversible Pulpitis Cases
A study testing dental pulpectomy using metapex and dental pulpotomy using biodentine in people with Dental Caries, run by Mohamed Ahmed Hamdi Abo El Yamin at 1 site in Egypt.
Trial summary
Irreversible pulpitis is defined as a clinical diagnostic based on subjective and objective findings suggesting that the vital inflamed pulp is incapable of healing in the American Association of Endodontists (AAE) Consensus Conference Recommended Diagnostic Terminology. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- dental pulpectomy using metapex and dental pulpotomy using biodentine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 15 Sep 2025
- 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 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Patient and parent showing cooperation and compliance.
- Children 4-9 years old
- Vital deeply carious primary(s) with complete root formation
- Asymptomatic teeth or without clinical symptoms of spontaneous pain
- No clinical evidence of pulp degeneration like the history of spontaneous or nocturnal pain, tenderness to percussion, pathologic tooth mobility, swelling, or fistulous tract.
- Both genders will be included.
Show all 10Show fewer
- No radiographic evidence of pulp degeneration such as internal root resorption, external root resorption, or furcal radiolucency.
- Presence of 2/3rd of root
- Teeth that can be restored
- Children with prior parental consent.
Who cannot join
- • soft tissue inflammation.
- tooth mobility.
- sinus tract.
- Any radiographic sign of periapical pathologies or pulp necrosis (periapical radiolucency, internal or external root resorption)
- History of any systemic disease
- Teeth showing clinical or radiographic evidence of pulp degeneration
- Hemostasis not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement
- The remaining radicular tissue was non-vital (with suppuration or purulence necrosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Calcium Silicate Cement (Biodentine) Used As A Pulpotomy Agent In Primary Molars With Irreversible Pulpitis Versus Pulpectomy Using Calcium Hydroxide Iodoform Paste (Metapex)
Irreversible pulpitis is defined as a clinical diagnostic based on subjective and objective findings suggesting that the vital inflamed pulp is incapable of healing in the American Association of Endodontists (AAE) Consensus Conference Recommended Diagnostic Terminology. Other characteristics include persistent heat discomfort, transferred pain, spontaneous pain, or no clinical symptoms but caries-induced inflammation, caries excavation, and trauma.".
Dental caries is one of the most frequently occurring diseases affecting human beings that becomes a challenge for dentists as the disease progresses. The ultimate goal of operative and endodontic treatment is to preserve and maintain the vitality of pulp to allow continued development of odontogenic apparatus.
Read the detailed description
Pulp interventions combine a medication with a pulp treatment technique. Preserving the health of the tooth and its supporting tissues is the aim of these procedures. Three pulp therapy options are available, depending on the severity of the disease: pulpectomy, pulpotomy, and direct pulp capping. Direct pulp capping includes applying a medicinal material directly to the exposed pulp; pulpotomy and pulpectomy require removing parts of the pulp or the entire pulp in the pulp chamber and root canal of the tooth. In these procedures, the caries and part of pulp tissue are removed, and then medications are applied. This method aids in preserving the tooth's transient integrity.
When more advanced caries lesions approach the pulp-dentin complex and produce pulp necrosis, endodontic therapy is one way to save primary teeth until exfoliation. Maintaining the child's primary teeth in their oral cavity while getting rid of any symptoms or indicators is the ultimate goal of endodontic therapy in pediatric dentistry (Afroz et al., 2019).
zinc oxide eugenol (ZOE) was Introduced in 1930 and has been the conventional and widely approved root canal filling material for primary teeth. With over 90% of cases successfully reported, studies using ZOE paste have shown moderate to high success rates. But it has some drawbacks as well, such as the slower rate of resorption than the root, the possibility of the developing successor teeth becoming misaligned, particularly in overfilled cases, and worries about the material's potential for reduced antibacterial activity after the material is set in place.
Because zinc oxide eugenol has some disadvantages, biodentine-which may be utilized in direct contact with pulpal tissue-has strong mechanical properties, a good capacity to seal with dentine, and a biocompatibility that is comparable to that of MTA. It fulfilled every requirement of the perfect restorative material, including patient acceptance, good mechanical and physical properties, technical elements from the dentist's perspective, and other clinical characteristics that enhanced the material's efficacy. If only a portion of the odontoblastic layer is damaged, biodentine may accelerate pulp repair and regeneration.
For primary teeth pulpectomy, Metapex (Metapex, Meta Dental, New York, USA) is an easy-to-apply option that combines iodoform and calcium hydroxide. According to studies, this material has a good rate of resorption, less void formation, and excellent clinical and radiographic results.
- Conditions
- Dental Caries
- Being tested
- dental pulpectomy using metapex, dental pulpotomy using biodentine
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental pulpectomy using metapexProcedure or surgery
Metapex: A dental pulpectomy treats tooth with irreversible pulpitis in primary and teeth by removing infected pulp tissue using files and irrigation in the radicular part. The procedure involves anesthesia, decay removal, pulp chamber access, filing and irrigation till we reach cleaned dried canals and applying a medicament like Metapex . The tooth is then restored with a filling, often a stainless steel crown. The loss of pulp tissue weakens the tooth's structure and increases the risk of fracture and infection.
dental pulpotomy using biodentineProcedure or surgery
Biodentine: A dental pulpotomy treats tooth decay or trauma in primary and young permanent teeth by removing infected pulp tissue in the crown while preserving healthy root pulp. The procedure involves anesthesia, decay removal, pulp chamber access, hemostasis, and applying a medicament like MTA or Biodentine. The tooth is then restored with a filling, often a stainless steel crown. Pulpotomies preserve tooth structure, relieve pain, and are less invasive than full root canals, but require regular follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Metapex | Active comparator | Partial pulpectomy using Calcium Hydroxide with Iodoform (Metapex ) in carious primary molars with irreversible pulpitis Receives: Procedure: dental pulpectomy using metapex |
| Biodentine | Experimental | Pulpotomy using Biodentine in carious primary molars with irreversible pulpitis Receives: Procedure: dental pulpotomy using biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic
Radiographic Furcation involvement: Furcation involvement will be assessed radiographically using DIGORA software, with visual interpretation assigning scores based on radiolucency levels: 0 for no radiolucency; 1 for radiolucency affecting up to ¼ of the furcation area extending towards the periapical region; 2 for radiolucency involving between ¼ and ½ of the furcation area extending towards the periapical region; and 3 for radiolucency affecting more than ½ of the furcation area extending towards the periapical region.
Measured: Twelve Months
Secondary outcomes (1)
Clinical
The presence of postoperative pain:The Wong-Baker FACES Pain Rating Scale, a self-report tool for acute pain, will be used to assess spontaneous pain and pain on biting. This scale ranges from 0 to 10, with six illustrated faces representing pain levels from "no hurt" to "hurts worst."
Measured: Twelve Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Oct 2024
- Primary completion1 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- PICO: Population: Children with vital deeply carious primary molars with irreversible pulpitis Intervention: Pulpotomy using Biodentine in carious primary molars with irreversible pulpitis. Comparator/Control: Parial pulpectomy using Calcium Hydroxide with Iodoform ( Metapex ) in carious primary molars with irreversible pulpitis. Outcomes: Primary outcome, The presence of any adverse radiographic findings (Periodontal membrane space widening, periapical radiolucency, bone resorption, or other pathological changes)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Ahmed Hamdi Abo El Yamin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Ahmed Hamdi Abo El Yamin, Cairo University
- Investigators
- Marwa Salamoon, Ph.D, Study chair, Lecturer of Pediatric Dentistry and Dental Public Health MSA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524921
- Sponsor's protocol ID
- 2024-1
- Status last verified
- Mar 2026
- First submitted
- 24 Jul 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Calcium Silicate Cement (Biodentine) Used As A Pulpotomy Agent In Primary Molars With Irreversible Pulpitis Versus Pulpectomy Using Calcium Hydroxide Iodoform Paste (Metapex)
- ClinicalTrials.gov ID
- NCT06524921
- Acronym / sponsor ID
- 2024-1
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mohamed Ahmed Hamdi Abo El YaminUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 29 Jul 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.
Irreversible pulpitis is defined as a clinical diagnostic based on subjective and objective findings suggesting that the vital inflamed pulp is incapable of healing in the American Association of Endodontists (AAE) Consensus Conference Recommended Diagnostic Terminology. Other characteristics include persistent heat discomfort, transferred pain, spontaneous pain, or no clinical symptoms but caries-induced inflammation, caries excavation, and trauma.".
Dental caries is one of the most frequently occurring diseases affecting human beings that becomes a challenge for dentists as the disease progresses. The ultimate goal of operative and endodontic treatment is to preserve and maintain the vitality of pulp to allow continued development of odontogenic apparatus.
Detailed description
Pulp interventions combine a medication with a pulp treatment technique. Preserving the health of the tooth and its supporting tissues is the aim of these procedures. Three pulp therapy options are available, depending on the severity of the disease: pulpectomy, pulpotomy, and direct pulp capping. Direct pulp capping includes applying a medicinal material directly to the exposed pulp; pulpotomy and pulpectomy require removing parts of the pulp or the entire pulp in the pulp chamber and root canal of the tooth. In these procedures, the caries and part of pulp tissue are removed, and then medications are applied. This method aids in preserving the tooth's transient integrity.
When more advanced caries lesions approach the pulp-dentin complex and produce pulp necrosis, endodontic therapy is one way to save primary teeth until exfoliation. Maintaining the child's primary teeth in their oral cavity while getting rid of any symptoms or indicators is the ultimate goal of endodontic therapy in pediatric dentistry (Afroz et al., 2019).
zinc oxide eugenol (ZOE) was Introduced in 1930 and has been the conventional and widely approved root canal filling material for primary teeth. With over 90% of cases successfully reported, studies using ZOE paste have shown moderate to high success rates. But it has some drawbacks as well, such as the slower rate of resorption than the root, the possibility of the developing successor teeth becoming misaligned, particularly in overfilled cases, and worries about the material's potential for reduced antibacterial activity after the material is set in place.
Because zinc oxide eugenol has some disadvantages, biodentine-which may be utilized in direct contact with pulpal tissue-has strong mechanical properties, a good capacity to seal with dentine, and a biocompatibility that is comparable to that of MTA. It fulfilled every requirement of the perfect restorative material, including patient acceptance, good mechanical and physical properties, technical elements from the dentist's perspective, and other clinical characteristics that enhanced the material's efficacy. If only a portion of the odontoblastic layer is damaged, biodentine may accelerate pulp repair and regeneration.
For primary teeth pulpectomy, Metapex (Metapex, Meta Dental, New York, USA) is an easy-to-apply option that combines iodoform and calcium hydroxide. According to studies, this material has a good rate of resorption, less void formation, and excellent clinical and radiographic results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- PICO: Population: Children with vital deeply carious primary molars with irreversible pulpitis Intervention: Pulpotomy using Biodentine in carious primary molars with irreversible pulpitis. Comparator/Control: Parial pulpectomy using Calcium Hydroxide with Iodoform ( Metapex ) in carious primary molars with irreversible pulpitis. Outcomes: Primary outcome, The presence of any adverse radiographic findings (Periodontal membrane space widening, periapical radiolucency, bone resorption, or other pathological changes)
| Arm | Type | Receives |
|---|---|---|
| Metapex | Active comparator | Procedure: dental pulpectomy using metapexPartial pulpectomy using Calcium Hydroxide with Iodoform (Metapex ) in carious primary molars with irreversible pulpitis |
| Biodentine | Experimental | Procedure: dental pulpotomy using biodentinePulpotomy using Biodentine in carious primary molars with irreversible pulpitis |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- • Patient and parent showing cooperation and compliance.
Key exclusion criteria (8 listed)
- • soft tissue inflammation.
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 |
|---|---|---|
| dental pulpectomy using metapexMetapex: A dental pulpectomy treats tooth with irreversible pulpitis in primary and teeth by removing infected pulp tissue using files and irrigation in the radicular part. The procedure involves anesthesia, decay removal, pulp chamber access, filing and irrigation till we reach cleaned dried canals and applying a medicament like Metapex . The tooth is then restored with a filling, often a stainless steel crown. The loss of pulp tissue weakens the tooth's structure and increases the risk of fracture and infection. | Procedure or surgery | Metapex |
| dental pulpotomy using biodentineBiodentine: A dental pulpotomy treats tooth decay or trauma in primary and young permanent teeth by removing infected pulp tissue in the crown while preserving healthy root pulp. The procedure involves anesthesia, decay removal, pulp chamber access, hemostasis, and applying a medicament like MTA or Biodentine. The tooth is then restored with a filling, often a stainless steel crown. Pulpotomies preserve tooth structure, relieve pain, and are less invasive than full root canals, but require regular follow-up. | Procedure or surgery | Biodentine |
Primary outcome
Radiographic
Time frame: Twelve Months
Radiographic Furcation involvement: Furcation involvement will be assessed radiographically using DIGORA software, with visual interpretation assigning scores based on radiolucency levels: 0 for no radiolucency; 1 for radiolucency affecting up to ¼ of the furcation area extending towards the periapical region; 2 for radiolucency involving between ¼ and ½ of the furcation area extending towards the periapical region; and 3 for radiolucency affecting more than ½ of the furcation area extending towards the periapical region.
1 secondary outcome
Clinical
Time frame: Twelve Months
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 24 Mar 2026.
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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.
Marwa Salamoon, Ph.D study chair
Lecturer of Pediatric Dentistry and Dental Public Health MSA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental pulpectomy using metapex and dental pulpotomy using biodentine in people with Dental Caries, run by Mohamed Ahmed Hamdi Abo El Yamin 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 10 inclusion and 8 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 24 Mar 2026. 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?
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?
Radiographic (time frame: Twelve Months). 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 24 Mar 2026.